FDA-2013-N-1524 Non USP Monographed And/Or Non FDA Approved Drug Substances

25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

CAS Dose Recognition in Bibliographies on Safety and Ingredient Name Chemical Name UNII Code Number Format Pharmacopeias Efficacy Data

2-ethylhexyl-4- 2-ethylhexyl-4- 93NOD9WBCS sunscreen phenylbenzophenone-2- phenylbenzophenone-2- carboxylic acid carboxylic acid

4-Aminopyridine 4-AP; Fampridine; 504-24-5 Reagent Federal Register 1999 Dalfampridine

5-Hydroxytryptophan (L) Oxitriptan; L-Tryptophan? 9/8/4350; 73- Powder USP 22-3

Page 1 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

7-Keto Dehydroepiandrosterone, 7-Keto DHEA 566-19-8 Powder Not USP Micronized

8-Methoxypsoralen 8-MOP; Methoxsalen? 298-81-7 USP if correct stuff Acacia Gum, Spray-Dried Powder Acacia Gum, Spray-Dried ? NF, FCC Powder Acacia Syrup Acacia Syrup NF Acepromazine Maleate Acepromazine Maleate 61-00-7 USP Acesulfame Potassium Acesulfame Potassium 55589-62-3 NF, FCC acetaminophen acetaminophen 362O9ITL9D USP, USPMC internal analgesic

acetaminophen acetaminophen 362O9ITL9D USP, USPMC menstrual/diuretic analgesic

acetaminophen acetaminophen 362O9ITL9D USP, UPSMC nighttime sleep aid

acetaminophen acetaminophen 362O9ITL9D USP, USPMC overindulgence in a hangover reliever

Acetaminophen Paracetamol 103-90-2 Powder USP Acetaminophen, 60 Mesh Paracetamol 103-90-2 Powder USP acetanilide acetanilide SP86R356CC Not in USPNF, FCC or USPMC internal analgesic

Page 2 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

acetaZOLAMIDE Acetazolamide 59-66-5 Tablet, Powder USP Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 17th ed. Hudson, OH. Lexi-Comp, Inc. 2010: 41-43.

acetic acid acetic acid Q40Q9N063P NF otic

acetic acid acetic acid Q40Q9N063P NF wart remover

Acetic Acid, 3% (w/v) Aqueous Acetic Acid, 3% (w/v) Not USP Solution Aqueous Solution Acetic Acid, 5% (w/v) Aqueous Acetic Acid, 5% (w/v) Liquid USP has a monograph for Otic Solution Aqueous Solution Solution Acetic Acid, Glacial Acetic Acid, Glacial USP acetic acid, glacial acetic acid, glacial Q40Q9N063P USP, FCC corn/callus remover

acetic acid, glacial acetic acid, glacial Q40Q9N063P USP, FCC wart remover

Acetone Dimethylformaldehyde, 2- 67-64-1 Liquid USP Reagents A list for Acetone Propanone acetone acetone 1364PS73AF USP, FCC skin protectant astringent

Page 3 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Acetone Sodium Bisulfite 2-Hydroxy-2- 540-92-1 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, propanesulfonic acid, name eds. Handbook of Pharmaceutical Excipients. sodium salt 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Acetyl glucosamine Glucosamine Hydrochloride? 66-84-2? USP if correct stuff

Acetyl Hexapeptide-3 Acetyl Hexapeptide-3 Not USP unless by another name Acetylcysteine Acetylcysteine 616-91-1 Oral or USP Morgan DL, Borys DJ. Chapter 45. Poisoning. Inhalation In: Stone CK, Humphries RL, eds. CURRENT solution, Diagnosis & Treatment: Emergency powder Medicine. 6th ed. New York: McGraw-Hill; 2011.

Acetylcysteine Acetylcysteine 616-91-1 Oral or USP Morgan DL, Borys DJ. Chapter 45. Poisoning. Inhalation In: Stone CK, Humphries RL, eds. CURRENT solution, Diagnosis & Treatment: Emergency powder Medicine. 6th ed. New York: McGraw-Hill; 2011. Acetyl-L-Carnitine Hydrochloride 2-(acetyloxy)-3-carboxy- 5080-50-2 powder Not USP unless by another N,N,N-trimethyl-, chloride, ®- name 1-propanaminiu; Acetyl-L- Carnitine

Acidophilus Lactobacillus Acidophilus Lactobacillus Powder Not USP, FCC?

Active Ingredient Chemical Name CAS Number UNII Code Dose Format Pharmacopeia Recognition Monograph and Sub-category Adenosine-5-triphosphate Adenosine? 58-61-7? On Negative list? USP if right disodium salt name and CAS. agar agar USP, FCC laxative bulk laxative

Page 4 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Alanine Alanine; L-Alanine 56-41-7 USP alcloxa alcloxa 18B8O9DQA2 Not in USPNF, FCC or USPMC acne

alcloxa alcloxa 18B8O9DQA2 Not in USPNF, FCC or USPMC anorectal keratolytic

alcloxa alcloxa 18B8O9DQA2 Not in USPNF, FCC or USPMC antifungal

Alcohol Ethanol; Ethyl Alcohol 64-17-5 Liquid USP, BP alcohol alcohol 3K9958V90M USP digestive aid

alcohol alcohol 3K9958V90M USP external analgesic insect bite/sting

alcohol alcohol 3K9958V90M USP external analgesic poison ivy/oak/sumac

alcohol alcohol 3K9958V90M USP menstrual/diuretic

alcohol alcohol 3K9958V90M USP oral heath care

Page 5 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

alcohol alcohol 3K9958V90M USP skin protectant

alcohol alcohol 3K9958V90M USP skin protectant astringent

alcohol alcohol 3K9958V90M USP skin protectant insect bites/stings

alcohol alcohol 3K9958V90M USP skin protectant poison ivy/oak/sumac

alcohol alcohol 3K9958V90M USP weight control

alcohol alcohol 3K9958V90M USP mercury

alcohol, ethoxylated alkyl alcohol, ethoxylated alkyl 3K9958V90M external analgesic insect bite/sting

alcohol, ethoxylated alkyl alcohol, ethoxylated alkyl 3K9958V90M skin protectant insect bites/stings

aldioxa aldioxa 8T66I31YNK Not in USPNF, FCC or USPMC skin protectant diaper rash

Aldosterone Aldosterone Not USP

Page 6 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

alfalfa alfalfa SQI2NBY9KR Not in USPNF, FCC or USPMC weight control

alfalfa leaves alfalfa leaves SQI2NBY9KR Not in USPNF, FCC or USPMC menstrual/diuretic

alginic acid alginic acid 8C3Z4148WZ NF weight control

Aliphatic Polyesters Numerous: Poly(DL-lactide- Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, co-glycolide)(100:0), (85:15), name eds. Handbook of Pharmaceutical Excipients. 975:25), (65:35), and 7th ed. London, UK. Pharmaceutical Press div Numerous at (50:50); Poly(L- Royal Pharmaceutical Society of Great Britain lactide), Poly(glycolide), Poly- and Washington, DC. American Pharmacists e-caprolactone Association; 2012.

Alitame Aclame; L-aspartyl-D-alanine-80863-62-3 USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, N-(2,2,4,4- (anhydrous) eds. Handbook of Pharmaceutical Excipients. tetramethylthietan-3-yl)a- and 99016-42- 7th ed. London, UK. Pharmaceutical Press div mide; 3-(L-aspartyl-D- 9 (hydrate) Royal Pharmaceutical Society of Great Britain alaninamido)-2,2,4,4- and Washington, DC. American Pharmacists tetramethylthietane Association; 2012.

alkyl dimethyl amine oxide and alkyl dimethyl amine oxide gingivitis/plaque aklyl dimethyl glycine and aklyl dimethyl glycine

alkyl isoquinolinium bromide alkyl isoquinolinium bromide acne

Page 7 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Allantoin Allantoin 97-59-6 USP allantoin allantoin 344S277G0Z USP dandruff analgesic

allantoin allantoin 344S277G0Z USP external analgesic

allantoin allantoin 344S277G0Z USP skin protectant

allantoin (5-ureidohydantoin) allantoin (5- 344S277G0Z USP corn/callus remover ureidohydantoin)

allantoin (with a minobenzoin allantoin (with a 344S277G0Z sunscreen acid) minobenzoin acid)

allantoin (wound healing claims allantoin (wound healing 344S277G0Z USP skin protectant only) claims only)

Allithiamine Thiamine Hydrochloride? 67-03-8? USP if correct stuff

Allopurinol Allopurinol Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 66-67.

Page 8 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

allyl isothiocyanate allyl isothiocyanate BN34FX42G3 cough/cold nasal decongestant

allyl isothiocyanate allyl isothiocyanate BN34FX42G3 external analgesic counterirritant pending

allyl isothiocyanate allyl isothiocyanate BN34FX42G3 external analgesic fever blister/cold sore

almadrate sulfate almadrate sulfate 9104833TPA Not in USPNF, FCC or USPMC digestive aid antacid

Almond Oil Almond Oil 8007-69-0 Oil USP aloe ingredients (aloe, aloe aloe ingredients (aloe, aloe V5VD430YW9, Not in USPNF, FCC or USPMC laxative stimulant laxative extract, aloe flower extract) extract, aloe flower extract) ZY8

Aloe Vera Aloe Vera Powder Not USP unless by another name aloe vera [see aloe} aloe vera [see aloe} 09TD8L5SQV Not in USPNF, FCC or USPMC gingivitis/plaque

Aloe Vera Gel Extract Aloe Vera Gel Extract 85507-69-3 Gel Extract, Not USP unless by another 200:1 name aloes aloes V5VD430YW9 USP menstrual/diuretic

aloin aloin W41H6S09F4 Not in USPNF, FCC or USPMC laxative stimulant laxative

Page 9 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

alpha Ketoglutaric acid alpha Ketoglutaric acid Not USP Alpha Tocopherol Alpha Tocopherol 10191-41-0 USP Alpha Tocopheryl Acetate Alpha Tocopheryl Acetate 7695-91-2 USP

alum, ammonium alum, ammonium DPU64XYB1D USP oral health care astringent

alum, ammonium alum, ammonium DPU64XYB1D USP skin protectant astringent

alum, potassium alum, potassium 1L24V9R23S USP antifungal

alum, potassium alum, potassium 1L24V9R23S USP antiperspirant

alum, potassium alum, potassium 1L24V9R23S USP oral health care

alum, potassium alum, potassium 1L24V9R23S USP skin protectant astringent

alumina powder, hydrated alumina powder, hydrated LMI26O6933 Not in USPNF, FCC or USPMC antidiarrheal

aluminum acetate aluminum acetate 80EHD8I43D Not in USPNF, FCC or USPMC external analgesic

Page 10 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

aluminum acetate aluminum acetate 80EHD8I43D Not in USPNF, FCC or USPMC skin protectant astringent

aluminum acetate aluminum acetate 80EHD8I43D Not in USPNF, FCC or USPMC skin protectant diaper rash

Aluminum Acetate Solution Burow's Solution 8006-13-1 Liquid USP aluminum chloride (alcoholic aluminum chloride (alcoholic LIF1N9568Y Not in USPNF, FCC or USPMC antiperspirant solutions) solutions)

aluminum chloride (aqueous aluminum chloride (aqueous LIF1N9568Y Not in USPNF, FCC or USPMC antiperspirant solution aerosol only) solution aerosol only)

aluminum chloride (nonaerosol aluminum chloride LIF1N9568Y Not in USPNF, FCC or USPMC antiperspirant aqueous solution) (nonaerosol aqueous solution)

aluminum chloride hexahydrate aluminum chloride LIF1N9568Y Not in USPNF, FCC or USPMC external analgesic hexahydrate

aluminum chlorohydrate aluminum chlorohydrate HPN8MZW13M USP antiperspirant

aluminum hydroxide aluminum hydroxide 5QB0T2IUN0 USP acne

aluminum hydroxide aluminum hydroxide 5QB0T2IUN0 USP anorectal protectant

Page 11 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

aluminum hydroxide aluminum hydroxide 5QB0T2IUN0 USP antacid

aluminum hydroxide aluminum hydroxide 5QB0T2IUN0 USP antidiarrheal

aluminum hydroxide aluminum hydroxide 5QB0T2IUN0 USP digestive aid antacid

aluminum hydroxide aluminum hydroxide 5QB0T2IUN0 USP overindulgence in a hangover reliever

aluminum hydroxide aluminum hydroxide 5QB0T2IUN0 USP skin protectant diaper rash

Aluminum Hydroxide Adjuvant Aluminum oxyhydroxide 21645-51-2 USP, PhEur Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

aluminum hydroxide gel aluminum hydroxide gel 5QB0T2IUN0 USP overindulgence in a hangover reliever

Page 12 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

aluminum hydroxide gel aluminum hydroxide gel 5QB0T2IUN0 USP skin progectant

aluminum hydroxide topical aluminum hydroxide topical 5QB0T2IUN0 analgesic diaper rash

aluminum hydroxide-hexitol, aluminum hydroxide-hexitol, 5QB0T2IUN0 antacid stabilized polymer stabilized polymer

aluminum hydroxide-magnesium aluminum hydroxide- 5QB0T2IUN0 antacid carbonate co-dried gel magnesium carbonate co- dried gel

aluminum hydroxide-magnesium aluminum hydroxide- 5QB0T2IUN0 antacid trisilicate co-dried gel magnesium trisilicate co- dried gel

aluminum hydroxide-sucrose aluminum hydroxide- 5QB0T2IUN0 antacid hydrated sucrose hydrated

aluminum phosphate aluminum phosphate F92V3S5210 Not in USPNF, FCC or USPMC antacid

Aluminum Phosphate Adjuvant Aluminum phosphate 7784-30-7 USP has Aluminum Phosphate Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Gel Monograph eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Page 13 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

aluminum phosphate gel (in aluminum phosphate gel (in F92V3S5210 USP antacid combination only) combination only)

aluminum sesquichlorohydrate aluminum UCN889409V USP antiperspirant sesquichlorohydrate

aluminum sesquichlorohydrate aluminum USP antiperspirant poylethylene glycol sesquichlorohydrate poylethylene glycol

aluminum sesquichlorohydrate aluminum USP antiperspirant propylene glycol sesquichlorohydrate propylene glycol

Aluminum Sulfate Aluminum Sulfate 17927-65-0 USP aluminum sulfate aluminum sulfate 34S289N54E USP antifungal

aluminum sulfate aluminum sulfate 34S289N54E USP, FCC antiperspirant

aluminum sulfate buffered aluminum sulfate buffered antiperspirant w/ sales less than $25,000 w/sodium aluminum lactate w/sodium aluminum lactate

aluminum sulfate, anhydrous aluminum sulfate, I7T908772F USP, FCC skin protectant astringent anhydrous

aluminum sulfate, buffered aluminum sulfate, buffered antiperspirant (aerosol only) (aerosol only)

Page 14 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

aluminum zirconium aluminum zirconium 481Y8HDW2B USP antiperspirant octachlorohydrate octachlorohydrate

aluminum zirconium aluminum zirconium P9D3YP29MY USP antiperspirant octachlorohydrex gly octachlorohydrex gly

aluminum zirconium aluminum zirconium 15K31617MU USP antiperspirant pentachlorohydrate pentachlorohydrate

aluminum zirconium aluminum zirconium 94703016SM USP antiperspirant pentachlorohydrex gly pentachlorohydrex gly

aluminum zirconium aluminum zirconium 8O386558JE USP antiperspirant tetrachlorohydrate tetrachlorohydrate

aluminum zirconium aluminum zirconium 8O386558JE USP antiperspirant tetrachlorohydrex gly tetrachlorohydrex gly

aluminum zirconium aluminum zirconium T27D6T99LH USP antiperspirant trichlorohydrate trichlorohydrate

aluminum zirconium aluminum zirconium T27D6T99LH USP antiperspirant trichlorohydrex gly trichlorohydrex gly

Amantadine Hydrochloride Amantadine Hydrochloride 665-66-7 USP

Page 15 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

aMILoride Amiloride Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 81-82.

amiloxate (isoamyl p- amiloxate (isoamyl p- 376KTP06K8 USP sunscreen methoxcinnamate) methoxcinnamate)

aminacrine hydrochloride aminacrine hydrochloride OR5RM3Q5QL Not in USPNF, FCC or USPMC boil treatment

Aminoacetic Acid Aminoacetic Acid USP lists in Reagents: Test Solutions for Sodium Aminoacetate aminoacetic acid aminoacetic acid TE7660XO1C Not in USPNF, FCC or USPMC antiemetic

aminobenzoic acid aminobenzoic acid TL2TJE8QTX USP internal analgesic

aminobenzoic acid (PABA) aminobenzoic acid (PABA) TL2TJE8QTX USP sunscreen

aminophylline aminophylline 27Y3KJK423 USPMC cough/cold bronchodilator

Aminosalicylic Acid 5-Aminosalicylic Acid 65-49-6 USP

Page 16 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Amiodarone Amiodarone Hydrochloride 19774-82-4 Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 84-89.

Amitriptyline Hydrochloride Amitriptyline Hydrochloride 549-18-8 USP

Amlodipine Amlodipine Besylate 111470-99-6 USP, EP Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 91-93.

ammonia solution, strong ammonia solution, strong 5138Q19F1X NF skin protectant insect bites/stings

ammonia solution, strong ammonia solution, strong 5138Q19F1X NF external analgesic fever blister/cold sore (ammonia water, strong) (ammonia water, strong)

ammoniated mercury ammoniated mercury JD546Z56F0 USP antimicrobial first aid antiseptic

Ammonium Alginate Ammonium alginat 9005-34-9 USP has an Ammonium Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Phosphate monograph eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Ammonium Alum Ammonium aluminum 7784-25-0 Powder USP sulfate

Page 17 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

ammonium bromide ammonium bromide R0JB3224WS Not in USPNF, FCC or USPMC nighttime sleep aid bromide

Ammonium Chloride Ammonium Chloride Injection, FDA approved product Powder

ammonium chloride ammonium chloride R0JB3224WS USP, FCC cough/cold expectorant

ammonium chloride ammonium chloride R0JB3224WS USP, FCC menstrual/diuretic

ammonium chloride ammonium chloride R0JB3224WS USP, FCC nighttime sleep aid

ammonium chloride ammonium chloride R0JB3224WS USP, FCC oral health care expectorant

ammonium chloride ammonium chloride R0JB3224WS USP, FCC stimulant

ammonium hydroxide ammonium hydroxide 5138Q19F1X Not in USPNF, FCC or USPMC skin protectant insect bites/stings

Amphotericin B Amphotericin B 1397-89-3 Powder USP

Page 18 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

amylase amylase YOJ58O116E Not in USPNF, FCC or USPMC digestive aid

anise oil anise oil 6Y89129C8H NF weight control

Anise Oil, Natural Anise Oil, Natural 800-70-3 Oil NF dosen't say natural anise seed anise seed 21C2F5E8RE Not in USPNF, FCC or USPMC digestive aid

antimony potassium tartrate antimony potassium tartrate DL6OZ476V3 USP cough/cold expectorant

antipyrine antipyrine T3CHA1B51H USP internal analgesic

antipyrine antipyrine T3CHA1B51H USP oral health care anesthetic/analgesic

antipyrine antipyrine T3CHA1B51H USP ophthalmic anesthetic

any atropine ingredient any atropine ingredient 7C0697DR9I USP internal analgesic

any atropine ingredient any atropine ingredient 7C0697DR9I USP menstrual/diuretic

Page 19 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

any ephedrine ingredient any ephedrine ingredient GN83C131XS internal analgesic

any ephedrine ingredient any ephedrine ingredient GN83C131XS menstrual/diuretic

Aprepitant Aprepitant Capsule, Taketomo CK, Hodding JH, Kraus DM. Powder Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 125- 126.

arbonate gel (basic) arbonate gel (basic) aluminum c antacid

Arginine Arginine; L-Arginine 74-79-3 Powder USP Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 131- 132.

arginine arginine 94ZLA3W45F USP, FCC weight control

Arginine Hydrochloride Arginine; L-Arginine 1119-34-2 Powder USP Hydrochloride Argireline 0.05% Acetyl Hexapeptide-3 Liquid Not USP aromatic powder aromatic powder Not in USPNF, FCC or USPMC digestive aid

Page 20 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

asafetida asafetida W9FZA51AS1 Not in USPNF, FCC or USPMC digestive aid

Asafetida Tincture Devil's Dung; Food-of-the- 900-04-8 Liquid Not USP Gods asclepias tuberosa asclepias tuberosa Y62M9GTW4A Not in USPNF, FCC or USPMC menstrual/diuretic botanical/vegetable herb

ascorbic acid ascorbic acid PQ6CK8PD0R USP, FCC corn/callus remover

ascorbic acid ascorbic acid PQ6CK8PD0R USP, FCC wart remover

ascorbic acid ascorbic acid PQ6CK8PD0R USP, FCC weight control

Ascorbic Acid Sodium Salt Ascorbic Acid? 50-81-7 USP if correct stuff Ascorbyl Palmitate Ascorbyl Palmitate; L- 137-66-6 Powder USP, FCC Ascorbic Acid Palmitate; L- Ascorbic Acid, 6- Hexadecanoate; Palmitoyl L- Ascorbic Acid

asparagus asparagus Z1EJP3037Z Not in USPNF, FCC or USPMC menstrual/diuretic

Aspartame N-L-alpha-Aspartyl-L- 22839-47-0 Powder USP, FCC phenylalanine 1-Methyl Ester; APM; Nutrasweet Aspartic Acid Aspartic Acid 689-03-2 Powder USP, FCC

Page 21 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

aspergillus oryza enzymes (except aspergillus oryza enzymes Q6Z8UK5R3G Not in USPNF, FCC or USPMC digestive aid lactase enzyme derivatived from (except lactase enzyme aspe) derivatived from aspe)

aspirin aspirin R16CO5Y76E USP internal analgesic cardiovascular

aspirin aspirin R16CO5Y76E USP internal analgesic rheumatologic

aspirin aspirin R16CO5Y76E USP external analgesic & anesthetic

aspirin aspirin R16CO5Y76E USP external analgesic fever blister/cold sore

aspirin aspirin R16CO5Y76E USP external analgesic poison ivy/oak sumac

aspirin aspirin R16CO5Y76E USP menstrual/diuretic analgesic

aspirin aspirin R16CO5Y76E USP overindulgence in a hangover reliever

aspirin (buffered) aspirin (buffered) R16CO5Y76E USP internal analgesic cardiovascular

Page 22 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

aspirin (buffered) aspirin (buffered) R16CO5Y76E USP internal analgesic rheumatologic

aspirin nighttime aspirin nighttime R16CO5Y76E sleep aid

aspirin oral aspirin oral R16CO5Y76E oral health care anesthetic/analgesic

aspirin, aluminum aspirin, aluminum R16CO5Y76E internal analgesic

aspirin, calcium aspirin, calcium R16CO5Y76E internal analgesic

aspirin, calcium aspirin, calcium R16CO5Y76E menstrual/diuretic

Atenolol Atenolol Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 147- 148. atropa belladonna atropa belladonna WQZ3G9PF0H cough/cold anticholinergic

Page 23 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

atropine atropine 7C0697DR9I USP anorectal anticholinergic

atropine sulfate atropine sulfate 03J5ZE7KA5 USP antidiarrheal

atropine sulfate atropine sulfate 03J5ZE7KA5 USP cough/cold anticholinergic

Attapulgite Attapulgite 12174-11-7 BP; USP has Activated Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Attapulgite monograph eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

attapulgite, activated attapulgite, activated U6V729APAM USP antidiarrheal w/ sales less than $25,000

avobenzone avobenzone G63QQF2NOX USP sunscreen

azaTHIOprine Azathioprine Tablet, Powder Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 161- 162.

Page 24 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Azelaic Acid Azelaic Acid 446-86-6 Flake Not USP unless by another name bacitracin bacitracin 58H6RWO52I USP first aid antibiotic ointment

Bacitracin Micronized Bacitracin Micronized 1405-87-4 Powder USP, EP bacitracin zinc bacitracin zinc 89Y4M234ES USP first aid antibiotic ointment

Baclofen Baclofen 1134-47-0 Tablet, Powder USP Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 171- 172.

barosma barosma Not in USPNF, FCC or USPMC menstrual/diuretic

basic fuchsin basic fuchsin 5P5C03819W Not in USPNF, FCC or USPMC antifungal

beachwood creosote beachwood creosote Not in USPNF, FCC or USPMC cough/cold expectorant

bean bean 8WB9PV3YW5 Not in USPNF, FCC or USPMC digestive aid

Page 25 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

bearberry bearberry 3M5V3D1X36 weight control

bearberry (extract of uva ursi) bearberry (extract of uva 3M5V3D1X36 menstrual/diuretic ursi)

bearberry fluidextract (extract of bearberry fluidextract 3M5V3D1X36 menstrual/diuretic bear berry) (extract of bear berry)

Beclomethasone Dipropionate Beclomethasone 0634-09-8 ? Powder USP Castilla C, Perez-Simon JA, Sanchez-Guijo FM, Dipropionate NDC 62991- et al. Oral Beclomethasone Dipropionate for 1020-4 the Treatment of Gastrointestinal Acute Graft-versus-Host Disease (GVHD). Biol Blood Marrow Transplant 2006; 12: 936-941.

Beeswax Yellow Wax? beeswax beeswax 2ZA36H0S2V skin protectant insect bites/stings w/ sales less than $25,000

beeswax beeswax 2ZA36H0S2V skin protectant poison ivy/oak/sumac w/ sales less than $25,000

beeswax beeswax 2ZA36H0S2V skin protectant w/ sales less than $25,000

Belladona Tincture Belladona Tincture 8007-93-0 Liquid USP monograph? belladonna alkaloids belladonna alkaloids WQZ3G9PF0H corn/callus remover

Page 26 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

belladonna alkaloids belladonna alkaloids WQZ3G9PF0H cough/cold anticholinergic

belladonna alkaloids belladonna alkaloids WQZ3G9PF0H cough/cold bronchodilator

belladonna alkaloids belladonna alkaloids WQZ3G9PF0H digestive aid

belladonna extract belladonna extract WQZ3G9PF0H anorectal anticholinergic

belladonna leaves, powdered belladonna leaves, 6GZW20TIOI digestive aid extract powdered extract

bemotrizinol bemotrizinol PWZ1720CBH sunscreen

benzalkonium chloride benzalkonium chloride F5UM2KM3W7 external analgesic insect bite/sting

benzalkonium chloride benzalkonium chloride F5UM2KM3W7 skin protectant astringent

benzalkonium chloride benzalkonium chloride F5UM2KM3W7 skin protectant insect bites/stings

Page 27 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

benzalkonium chloride benzalkonium chloride PH41D05744 skin protectant astringent

benzalkonium chloride benzalkonium chloride PH41D05744 skin protectant poison ivy/oak/sumac

Benzalkonium Chloride 50% Benzalkonium; CAS 7732-18- 8001-54-5 Liquid/Solution NF 5 Water; CAS 64-17-5 Ethanol benzethonium chloride benzethonium chloride F5UM2KM3W7 antimicrobial

benzethonium chloride benzethonium chloride F5UM2KM3W7 antimicrobial

Page 28 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

benzethonium chloride benzethonium chloride F5UM2KM3W7 antimicrobial

benzethonium chloride benzethonium chloride F5UM2KM3W7 dandruff

benzethonium chloride benzethonium chloride PH41D05744 antifungal

benzethonium chloride benzethonium chloride PH41D05744 antimicrobial

Page 29 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

benzethonium chloride benzethonium chloride PH41D05744 antimicrobial

benzethonium chloride benzethonium chloride PH41D05744 dandruff

benzethonium chloride benzethonium chloride PH41D05744 external analgesic poison ivy/oak/sumac

benzocaine benzocaine U3RSY48JW11 oral health care anesthetic/analgesic

benzocaine benzocaine U3RSY48JW12 otic

benzocaine benzocaine U3RSY48JW13 pediculicide

benzocaine benzocaine U3RSY48JW14 relief of oral discomfort

benzocaine benzocaine U3RSY48JW15 relief of oral discomfort

Page 30 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

benzocaine benzocaine U3RSY48JW5 acne

benzocaine benzocaine U3RSY48JW5 external analgesic male genital desensitizer

benzocaine benzocaine U3RSY48JW7 dandruff

benzocaine benzocaine U3RSY48JW10 external analgesic

benzocaine benzocaine U3RSY48JW16 skin protectant astringent

benzocaine benzocaine U3RSY48JW17 skin protectant poison ivy/oak/sumac

benzocaine benzocaine U3RSY48JW18 wart remover

benzocaine benzocaine U3RSY48JW19 weight control

benzocaine benzocaine U3RSY48JW6 anorectal local anesthetic

Page 31 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

benzocaine (0.5 - 1.25%) benzocaine (0.5 - 1.25%) U3RSY48JW9 external analgesic poison ivy/oak/sumac

benzoic acid benzoic acid 8SKN0B0MIM acne

benzoic acid benzoic acid 8SKN0B0MIM antifungal

benzoic acid benzoic acid 8SKN0B0MIM oral health care

benzoic acid benzoic acid 8SKN0B0MIM skin protectant astringent

benzoin preparations (compound benzoin preparations L7J6A1NE81 cough/cold expectorant tincture of benzoin, tincture of (compound tincture of benz) benzoin, tincture of benz)

Benzoin Tincture Plain Benzoin Tincture Plain 119-53-9 Liquid USP monograph? benzoin tincture, compound benzoin tincture, compound L7J6A1NE81 relief of oral discomfort

benzonatate benzonatate 5P4DHS6ENR cough/cold antitussive

benzoxiquine benzoxiquine GRE0P19C3Z antifungal

Page 32 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

benzoyl peroxide benzoyl peroxide W9WZN9A0GM acne

benzyl alcohol benzyl alcohol LKG8494WBH anorectal local anesthetic

benzyl alcohol benzyl alcohol LKG8494WBH external analgesic & anesthetic

benzyl alcohol benzyl alcohol LKG8494WBH external analgesic male genital desensitizer

benzyl alcohol benzyl alcohol LKG8494WBH oral health care anesthetic/analgesic

benzyl alcohol benzyl alcohol LKG8494WBH pediculicide

benzyl alcohol benzyl alcohol LKG8494WBH relief of oral discomfort

benzyl alcohol benzyl alcohol LKG8494WBH skin protectant poison ivy/oak/sumac

Page 33 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

benzyl benzonate benzyl benzonate N863NB338G pediculicide

Betahistine dihydrochloride 2-Pyridineethanamine, N- 5579-84-0 USP Federal Register 1999 methyl-, dihydrochloride

Betaine Hydrochloride Betaine Hydrochloride 590-46-5 USP betaine hydrochloride betaine hydrochloride JK8U8K4D6K digestive aid

Betaine, Anhydrous Betaine Base 107-43-7 Powder USP Betamechlomethasone Betamechlomethasone Not USP beta-Nicotinamide Adenine beta-NADH Disodium Salt; 606-68-8 Powder Not USP unless by another Dinucleotide Disodium Salt, beta-NADH; Reduced NAD; name Trihydrate, Reduced Reduced DPN

Page 34 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Bethanechol Bethanechol Chloride 590-63-6 Tablet, Powder USP, Reagent Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 191- 192. Bethanechol Bethanechol Chloride 590-63-6 Tablet, Powder USP, Reagent Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 191- 192. bicarbonate bicarbonate antacid

Bichloroacetic Acid Bichloroacetic Acid Not USP unless by another name bile salts/acids bile salts/acids laxative stimulant laxative

Biotin Biotin (D), (Vitamin H) 58-85-5 Powder USP, FCC Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 194.

biotin biotin 6SO6U10H04 weight control

Bipeptide Biocosmetic Bipeptide Biocosmetic Not USP unless by another name bisacodyl bisacodyl 10X0709Y6I laxative

bismuth aluminate bismuth aluminate JB5Y63JDHJ antacid

Page 35 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

bismuth carbonate bismuth carbonate M41L2IN55T antacid

Bismuth citrate Bismuth citrate 813-93-4 USP Federal Register 1999

bismuth oxide bismuth oxide A6I4E79QF1 anorectal protectant

bismuth sodium tartrate bismuth sodium tartrate digestive aid

bismuth sodium tartrate bismuth sodium tartrate external analgesic fever blister/cold sore

bismuth subcarbonate bismuth subcarbonate M41L2IN55T anorectal protectant

bismuth subcarbonate bismuth subcarbonate M41L2IN55T antacid

Page 36 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

bismuth subcarbonate bismuth subcarbonate M41L2IN55T digestive aid

bismuth subgallate bismuth subgallate YIW503MI7V anorectal protectant

bismuth subgallate bismuth subgallate YIW503MI7V antacid

bismuth subgallate bismuth subgallate YIW503MI7V deoderant

bismuth subgallate bismuth subgallate YIW503MI7V digestive aid

bismuth subnitrate bismuth subnitrate H19J064BA5 skin protectant

bismuth subnitrate bismuth subnitrate YIW503MI7V antidarrheal w/ sales less than $25,000

Page 37 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

bismuth subnitrate bismuth subnitrate YIW503MI7V skin protectant fever blister/cold sore

bismuth subnitrate bismuth subnitrate YIW503MI7V skin protectant insect bites/stings w/ sales less than $2

bismuth subnitrate bismuth subnitrate YIW503MI7V skin protectant poison ivy/oak/sumac

bismuth subnitrate bismuth subnitrate YIW503MI7V skin protectant w/ sales less than $25,000

bismuth subsalicylate bismuth subsalicylate 62TEY51RR1 antidiarrheal

bismuth subsalicylate bismuth subsalicylate 62TEY51RR2 antiemetic

bismuth subsalicylate bismuth subsalicylate 62TEY51RR3 antimicrobial

bismuth subsalicylate bismuth subsalicylate 62TEY51RR4 oral health care

Page 38 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

bismuth subsalicylate bismuth subsalicylate 62TEY51RR5 overindulgence in a hangover reliever

bisoctrizole bisoctrizole 8NT850T0YS sunscreen

bithionol bithionol AMT77LS62O external analgesic poison ivy/oak/sumac

bithionol bithionol AMT77LS62O skin protectant poison ivy/oak/sumac

Black Currant Oil Black Currant Oil Oil or Powder?

black radish powder black radish powder 86R5J6D01D digestive aid

blessed thistle (cnicus benedictus) blessed thistle (cnicus 6L5ZL09795 digestive aid benedictus)

blessed thistle (cnicus benedictus) blessed thistle (cnicus 6L5ZL09795 menstrual/diuretic benedictus)

bone marrow red bone marrow red weight control

Boric Acid Boric Acid NDC 0395-303- Powder NF 96

Page 39 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

boric acid boric acid R57ZHV85D4 acne

boric acid boric acid R57ZHV85D6 antifungal

boric acid boric acid R57ZHV85D7 dandruff

boric acid boric acid R57ZHV85D10 skin protectant fever blister/cold sore

boric acid boric acid R57ZHV85D11 skin protectant insect bites/stings w/ sales less than $2

boric acid boric acid R57ZHV85D12 skin protectant poison ivy/oak/sumac

boric acid boric acid R57ZHV85D13 skin protectant poison ivy/oak/sumac w/ sales less than $25,000

boric acid boric acid R57ZHV85D14 skin protectant w/ sales less than $25,000

boric acid boric acid R57ZHV85D5 anorectal antiseptic

Page 40 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

boric acid boric acid R57ZHV85D8 ophthalmic anti-infective

boric acid boric acid R57ZHV85D9 skin protectant astringent

bornelone (5-(3,3-dimethyl-2- bornelone (5-(3,3-dimethyl- LU86E5P72A sunscreen norbornyllDEN)3-pentene-2-one) 2-norbornyllDEN)3-pentene- 2-one)

bornyl acetate bornyl acetate cough/cold nasal decongestant

boroglycerin boroglycerin anorectal antiseptic

boroglycerin boroglycerin oral health care

bran bran laxative

Page 41 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Brilliant Green C.I. 42040 Brillient Green Powder Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 645.

Bromelain Bromelain Not USP, FCC? brompheniramine maleate brompheniramine maleate IXA7C9ZN03 cough/cold antihistamine

Bronopol 2-Bromo-2-nitropropane-1,3-52-51-7 BP, Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, diol eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

buchu buchu KOS935A04V weight control

buchu powdered extract (extract buchu powdered extract KOS935A04V menstrual/diuretic of buchu) (extract of buchu)

buchu, potassium extract buchu, potassium extract KOS935A04V weight control

Page 42 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

buckthorn buckthorn 2C5Q57D7Z4 digestive aid

Budesonide Inhalation Budesonide 51333-22-3 Suspension USP Andre H, Hilgendorf I, Leithaeuser M, Suspension 0.5 mg / mL Junghanss C, et al. Enteral budesonide in treatment for mild and moderate gastrointestinal chronic GVHD. BMT (2008) 42, 541-546.

Budesonide, Micronized 16k,17-Butylidenebis[oxy]- 51333-22-3 Powder USP Andre H, Hilgendorf I, Leithaeuser M, 11,21-dihydroxypregna-1,4- Junghanss C, et al. Enteral budesonide in diene-3,20-dione treatment for mild and moderate gastrointestinal chronic GVHD. BMT (2008) 42, 541-546.

Buffer Solution, pH Buffer Acid Buffer Solution, pH Buffer ? (pH 4.01) Acid (pH 4.01) Buffer Solution, pH Buffer Buffer Solution, pH Buffer ? Alkaline (pH 10.00) Alkaline (pH 10.00)

Buffer Solution, pH Buffer Neutral Buffer Solution, pH Buffer ? (pH 7.00) Neutral (pH 7.00) Bupivacaine Hydrochloride Bupivacaine Hydrochloride 14252-80-3 USP

Bupropion Hydrochlroide Bupropion Hydrochlroide 53152-21-9 USP

busPIRone Buspirone Hydrochloride 33386-08-2 Powder USP

Busulfan Busulfan Tablet, Powder FDA approved product

Page 43 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

butacaine sulfate butacaine sulfate PAU39W3CVB relief of oral discomfort

butamben picrate butamben picrate external analgesic

Butyl Stearate Butyl octadecanoate 123-95-5 USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Butylated Hydroxytoluene (BHT) Phenol, 2,6-bis(1,1- 128-37-0 Liquid NF dimethylethyl)-4-methyl-; 2,6-Di-tert-butyl-p-cresol

Butylene Glycol 1,3-Butanediol 107-88-0 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, name eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

caffeine caffeine 3G6A5W338E overindulgence in a hangover reliever

Page 44 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

caffeine caffeine 3G6A5W338E stimulant

caffeine caffeine 3G6A5W338E analgesic

caffeine caffeine 3G6A5W338E cough/cold miscellaneous

caffeine caffeine 3G6A5W338E menstrual/diuretic

caffeine caffeine 3G6A5W338E menstrual/diuretic analgesic

caffeine caffeine 3G6A5W338E nighttime sleep aid stimulant

caffeine caffeine 3G6A5W338E weight control

Page 45 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Caffeine citrate Caffeine Citrated (Purified) 58-08-2? USP? Federal Register 1999

caffeine citrate caffeine citrate U26EO4675Q weight control

calamine calamine anorectal astringent

calamine calamine external analgesic insect bite/sting

calamine calamine external analgesic poison ivy/oak/sumac

calamine calamine skin protectant

calamine (in combination only) calamine (in combination anorectal protectant only)

Page 46 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

calcium calcium weight control

calcium (mono or dibasic salt) calcium (mono or dibasic SY7Q814VUP antacid salt)

calcium acetate calcium acetate Y882YXF34X skin protectant astringent

Calcium Alginate Calcium alginate 9005-35-0 Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

calcium carbonate calcium carbonate H0G9379FGK antacid

calcium carbonate calcium carbonate H0G9379FGK digestive aid antacid

calcium carbonate calcium carbonate H0G9379FGK weight control

calcium carbonate precipated calcium carbonate H0G9379FGK antidiarrheal precipated

Page 47 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

calcium caseinate calcium caseinate weight control

Calcium Folinate Calcium Folinate Not USP calcium gluconate calcium gluconate SQE6VB453K digestive aid

Calcium glycinate Calcium glycinate Not USP calcium hydroxide calcium hydroxide PF5DZW74VN antidiarrheal w/ sales less than $25,000

calcium lactate calcium lactate 2URQ2N32W3 menstrual/diuretic

calcium lactate calcium lactate 2URQ2N32W3 weight control

calcium pantothenate calcium pantothenate 568ET80C3D laxative stimulant laxative

calcium pantothenate calcium pantothenate 568ET80C3D menstrual/diuretic

calcium pantothenate calcium pantothenate 568ET80C3D wart remover

Page 48 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

calcium pantothenate calcium pantothenate 568ET80C3D weight control

calcium phosphate calcium phosphate H0G9379FGK antacid

calcium polycarbophil calcium polycarbophil antidiarrheal w/ sales less than $2

calcium polycarbophil calcium polycarbophil laxative bulk laxative

calcium polysulfidelysuldfide calcium polysulfidelysuldfide acne

calcium salicylate calcium salicylate internal analgesic

calcium sucrose phosphate calcium sucrose phosphate anticaries

calcium thiosulfate calcium thiosulfate 210100728E acne

calcium undecylenate calcium undecylenate 77YW1RTU8V antifungal

Page 49 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

calcium undecylenate calcium undecylenate 77YW1RTU8V antimicrobial

calcium undecylenate calcium undecylenate 77YW1RTU8V dandruff

calomel calomel J2D46N657D laxative stimulant laxative

calomel (mercurous chloride) calomel (mercurous J2D46N657D antimicrobial first aid antiseptic chloride)

camphor camphor 5TJD82A1ET acne

camphor camphor 5TJD82A1ET anorectal counterritant

camphor camphor 5TJD82A1ET antifungal

camphor camphor 5TJD82A1ET cough/cold antitussive

Page 50 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

camphor camphor 5TJD82A1ET cough/cold expectorant

camphor camphor 5TJD82A1ET cough/cold nasal decongestant

camphor camphor 5TJD82A1ET external analgesic

camphor camphor 5TJD82A1ET oral health care anesthetic/analgesic

camphor camphor 5TJD82A1ET oral health care non-antimicrobial

camphor camphor 5TJD82A1ET skin protectant insect bites/stings

camphor camphor 5TJD82A1ET skin protectant poison ivy/oak/sumac

Page 51 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

camphor camphor 5TJD82A1ET sunscreen in active

camphor camphor 5TJD82A1ET wart remover

camphor camphor 5TJD82A1ET relief of oral discomfort

camphor (exceding 3%) camphor (exceding 3%) 5TJD82A1ET external analgesic fever blister/cold sore

camphor (lozenge) camphor (lozenge) 5TJD82A1ET cough/cold nasal decongestant

camphor gum camphor gum 5TJD82A1ET skin protectant astringent

camphorated metacresol camphorated metacresol antifungal

camphorated metacresol camphorated metacresol external analgesic & anesthetic

camphorated metacresol camphorated metacresol external analgesic male genital desensitizer

Page 52 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

candicidin candicidin antifungal

Cantharidin Cantharidin 56-25-7 Powder, Not USP Federal Register 1999 Crystals

Caprylic Acid Sodium Salt Caprylic Acid Sodium Salt 124-07-2 USP

Capsaicin Capsaicin 404-86-4 USP capsaicin capsaicin S07O44R1ZM external analgesic fever blister/cold sore

capsicum capsicum S07O44R1ZM digestive aid

capsicum capsicum S07O44R1ZM external analgesic fever blister/cold sore

capsicum capsicum S07O44R1ZM relief of oral discomfort

Page 53 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

capsicum capsicum S07O44R1ZM relief of oral discomfort

capsicum oleoresin capsicum oleoresin S07O44R1ZM external analgesic fever blister/cold sore

capsicum oleoresin capsicum oleoresin S07O44R1ZM menstrual/diuretic

capsicum, fluid extract of carbon capsicum, fluid extract of S07O44R1ZM digestive aid carbon

Capsules, Empty Gelatin Capsules, Empty Gelatin ? Vegetable Vegetable captan captan dandruff

Captopril Captopril Tablet, Powder FDA approved product

caramiphen edisylate caramiphen edisylate 09TQU5PG95 cough/cold antitussive

Carbamazepine Carbamazepine 298-46-4 USP Carbamide Carbamide 298-46-4 Not USP

carbamide peroxide carbamide peroxide 31PZ2VAU81 oral health care

Page 54 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

carbamide peroxide carbamide peroxide 31PZ2VAU81 oral health care

carbamide peroxide (in carbamide peroxide (in 31PZ2VAU81 oral health care wound cleaning anhydrous glycerin) anhydrous glycerin)

carbamide peroxide 6.5% (in carbamide peroxide 6.5% (in 31PZ2VAU81 otic anhydrous glycerin) anhydrous glycerin)

carbaspirin calcium carbaspirin calcium N667F17JP1 internal analgesic

carbaspirin calcium carbaspirin calcium N667F17JP1 menstrual/diuretic analgesic

Carbazochrome Adrenochrome 69-81-8 Reagent, Not USP Monosemicarbazone; 3- Hydroxy-1-methyl-5,6- indolin-edione Semicarbazone carbetapentane citrate carbetapentane citrate 4SH0MFJ5HJ cough/cold antitussive

Carbimazole Carbimazole Not USP Carbolic Acid Phenol 108-95-2 Not USP Carbomer 940 Acritamer 940 NF

Page 55 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Carbomer Gel - Aqueous Carbomer Gel - Aqueous Cream No but mentioned in <1151>

Carbomer Gel - Hydroalcoholic Carbomer Gel - Cream No but mentioned in <1151> Hydroalcoholic

carbon carbon 2P3VWU3H10 digestive aid

carbon dioxide released carbon dioxide released 142M471B3J laxative

carboxymethylcellulose sodium carboxymethylcellulose K679OBS311 antidiarrheal sodium

carboxymethylcellulose sodium carboxymethylcellulose K679OBS311 laxative sodium

carboxymethylcellulose sodium carboxymethylcellulose K679OBS311 ophthalmic demulcents sodium

carboxymethylcellulose sodium carboxymethylcellulose K679OBS311 weight control sodium

Carnitine-L Carnitine (L) 541-15-1 Not USP unless by another name

Page 56 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

carrageenan carrageenan 5C69YCD2YJ weight control

carrageenan (degraded) carrageenan (degraded) 5C69YCD2YJ laxative bulk laxative

carrageenan (natural) carrageenan (natural) 5C69YCD2YJ laxative bulk laxative

Carvedilol Carvedilol Tablet, Powder FDA approved product

casanthranol casanthranol laxative stimulant laxative

cascara fluidextract (aromatic) cascara fluidextract laxative stimulant laxative (aromatic)

cascara fluidextract, aromatic cascara fluidextract, menstrual/diuretic (extract of cascara) aromatic (extract of cascara)

cascara sagrada bark cascara sagrada bark 4VBP01X99F laxative stimulant laxative

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cascara sagrada extract cascara sagrada extract digestive aid

cascara sagrada extract cascara sagrada extract laxative stimulant laxative

cascara sagrada fluidextract cascara sagrada fluidextract laxative stimulant laxative

castor oil castor oil D5340Y2I9G laxative stimulant laxative

castor opil castor opil D5340Y2I9G wart remover

catechu, tinctures catechu, tinctures 483O0360NZ digestive aid

cation exchange resins buffered cation exchange resins anion and skin protectant poison ivy/oak/sumac buffered

catnip catnip 7Y51EV0DZW digestive aid

Caustic Potash Potassium Hydroxide 1310-58-3 Not USP unless by another name Caustic Soda Sodium Hydroxide 1310-73-2 Not USP unless by another name

Page 58 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

cedar leaf oil (topical) cedar leaf oil (topical) BJ169U4NLG cough/cold nasal decongestant

Cedarwood Essential Oil Cedarwood Essential Oil 800-27-9 Oil Not USP unless by another name Cefazolin Cefazolin 25953-19-9 USP cellulase cellulase digestive aid

cellulose, microporous cellulose, microporous SMD1X3XO9M skin protectant diaper rash

Ceratonia Carob gum 9000-40-2 USP Reagents: L states that Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Locust Bean Gum is obtained eds. Handbook of Pharmaceutical Excipients. from endosperms of Ceratonia 7th ed. London, UK. Pharmaceutical Press div siliqu. Use Locust Bean Gum, Royal Pharmaceutical Society of Great Britain FCC. and Washington, DC. American Pharmacists Association; 2012.

Ceresin Ceresin wax 8001-75-0 Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

cetalkonium chloride cetalkonium chloride 85474O1N9D external analgesic poison ivy/oak/sumac

Page 59 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

cetalkonium chloride cetalkonium chloride 85474O1N9D skin protectant poison ivy/oak/sumac

Cetrimide Cetyltrimethylammonium 8044-71-1 BP, PhEur; USP has CAS number Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Bromide of 57-09-0 eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

cetyl alcohol cetyl alcohol 936JST6JCN skin protectant insect bites/stings

cetyl alcohol cetyl alcohol 936JST6JCN skin protectant poison ivy/oak/sumac

cetyl alcohol cetyl alcohol 936JST6JCN skin protectant sales w/less than $25,000

cetylpyridinium chloride cetylpyridinium chloride D9OM4SK49P oral health care

chamomile flowers chamomile flowers O2T154T6OG digestive aid

charcoal (activated) charcoal (activated) 2P3VWU3H10 antidiarrhea w/ sales less than $25,000

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

charcoal, activated charcoal, activated 2P3VWU3H10 acute toxic ingestion

Charcoal, activated Charcoal, activated 2P3VWU3H10 antacid

charcoal, activated charcoal, activated 2P3VWU3H10 deoderants for internal use

charcoal, activated charcoal, activated 2P3VWU3H10 overindulgence in a hangover reliever/minimizer

charcoal, activated charcoal, activated 2P3VWU3H10 poison treatment

charcoal, wood/ac charcoal, wood/ac 2P3VWU3H10 digestive aid

chlophedianol hydrochloride chlophedianol hydrochloride 69QQ58998Y cough/cold antitussive

chloral hydrate chloral hydrate 418M5916WG external analgesic & anesthetic

chloral hydrate chloral hydrate 418M5916WG external analgesic counter irritant

Page 61 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

chloral hydrate chloral hydrate 418M5916WG external analgesic fever blister/cold sore

chloral hydrate chloral hydrate 418M5916WG external analgesic poison ivy/oak/sumac

chloral hydrate chloral hydrate 418M5916WG skin protectant poison ivy/oak/sumac

Chloramphenicol Chloramphenicol 250 mg Ora-Blend Taketomo CK, Hodding JH, Kraus DM. capsule Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 289- 290.

chlorcyclizine hydrochloride chlorcyclizine hydrochloride NPB7A7874U cough/cold antihistamine

Chlorhexidine Chlorhexidine 55-56-1 USP Chlorhexidine Acetate Chlorhexidine Acetate 56-95-1 USP Chlorhexidine Diacetate Hydrate Chlorhexidine Diacetate Not USP unless by another Hydrate name chlorhydroxyquinoline (cloxyquin) chlorhydroxyquinoline BPF36H1G6S acne (cloxyquin)

chlorobutanol chlorobutanol HM4YQM8WRC corn/callus remover

Page 62 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

chlorobutanol chlorobutanol HM4YQM8WRC external analgesic & anesthetic

chlorobutanol chlorobutanol HM4YQM8WRC external analgesic & anesthetic fever blister/cold sore

chlorobutanol chlorobutanol HM4YQM8WRC external analgesic poison ivy/oak/sumac

chloroform chloroform 7V31YC746X cough/cold expectorant

chloroform chloroform 7V31YC746X digestive aid

Chloroform Reagent Trichloromethane 67-66-3 Liquid Not USP unless by another name chlorophenothane chlorophenothane CIW5S16655 pediculicide (dichlorodiphenyl (dichlorodiphenyl trichloroethane) trichloroethane)

chlorophyllin chlorophyllin relief of oral discomfort

chlorophyllin copper complex chlorophyllin copper deodorants for internal use complex

Page 63 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

chlorophyllin copper complex chlorophyllin copper oral health care complex

Chloroquine Chloroquine FDA approved product Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 293- 295.

Chloroquine Phosphate Chloroquine Phosphate 50-63-5 Powder USP, EP Chlorothiazide Chlorothiazide Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 295- 296.

chlorothymol chlorothymol LJ25TI0CVT antifungal

chloroxlyneol chloroxlyneol LJ25TI0CVT antimicrobial

Page 64 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

chloroxlyneol chloroxlyneol LJ25TI0CVT antimicrobial

chloroxylenol chloroxylenol LJ25TI0CVT acne

chloroxylenol chloroxylenol LJ25TI0CVT antifungal

chloroxylenol chloroxylenol LJ25TI0CVT dandruff

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

chlorpheniramine maleate chlorpheniramine maleate V1Q0O9OJ9Z cough/cold antihistamine

chlorpheniramine maleate chlorpheniramine maleate V1Q0O9OJ9Z external analgesic poison ivy/oak/sumac

chlorpheniramine maleate chlorpheniramine maleate V1Q0O9OJ9Z skin protectant poison ivy/oak/sumac

chlorprophenpyridamine maleate chlorprophenpyridamine menstrual/diuretic maleate

chlortetracycline hydrochloride chlortetracycline O1GX33ON8R first aid antibiotic ointment hydrochloride

cholecalciferol cholecalciferol 1C6V77QF41 skin protectant diaper rash

cholecalciferol cholecalciferol 1C6V77QF41 weight control

cholecalciferol (vitamin D) cholecalciferol (vitamin D) 1C6V77QF41 anorectal wound healing

Cholesterol Cholesterol Powder Ora-Plus Cherry Syrup, Iron SM. Smith-Lemli-Opitz Syndrome. Gene NF Reviews. http://www.ncbi.nlm.nih.gov/books/bv.fcgi?i ndexed=google&rid=gene.chapter.slo Accessed 3-31-2008.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Cholestyramine / Nystatin / Zinc Cholestyramine for Oral Nystatin Zinc Oxide 40% Cholestyramine for Oral Suspension, USP. Oxide Suspension, USP (4 gram Topical with Mineral [Package insert]. Par Pharmaceutical packet) Powder, USP Oil Paste Companies, Inc., Spring Valley, NY. 100,000 units / gram

choline choline N91BDP6H0X weight control

Choline bitartrate (2- 87-67-2 Powder USP, FCC Federal Register 1999 Hydroxyethyl)trimethylamm onium Bitartrate; Choline Acid Tartrate; Choline Hydrogen Tartrate; CBT

Choline Chloride (2- 67-48-1 Powder USP, FCC Hydroxyethyl)trimethylamm onium Chloride Choline magnesium trisalicylate Choline magnesium Not USP trisalicylate choline salicylate choline salicylate N91BDP6H0X internal analgesic

choline salicylate choline salicylate N91BDP6H0X menstrual/diuretic analgesic

Page 67 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Chondroitin Sulfate Chondroitin Sulfate 9007-28-7 Powder Not USP unless by another name Chondroitin Sulfate Sodium Chondroitin Sulfate Sodium 9082-07-9 USP

chondrus chondrus XR12Z4HLEA weight control

Chromium glycinate Chromium glycinate Not USP Chromium Picolinate Picolinic Acid Chromium 14639-25-9 Powder USP Salt; Chromium Tripicolinate

Chrysin 5,7-Dihydroxyflavone 480-40-0 Powder Not USP Cidofovir Cidofovir Not USP cidophilus cidophilus bacillus a digestive aid

cimicifuga racemosa cimicifuga racemosa K73E24S6X9 menstrual/diuretic botanical/vegetable herb

cinnamedrine hydrochloride cinnamedrine hydrochloride T4B6SPQ0UF menstrual/diuretic muscle relaxant

cinnamon oil dige cinnamon oil dige E5GY4I6YCZ digestive aid

cinnamon tincture cinnamon tincture 5S29HWU6QB digestive aid

Page 68 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

cinoxate cinoxate 5437O7N5BH sunscreen

Ciprofloxacin Ciprofloxacin 85721-33-1 USP Cisapride Cisapride 260779-88-2 USP

citrate (containing active citrate (containing active antacid ingredients: citrate ion, as citric ingredients: citrate ion, as acid or salt) citric acid or salt)

citric acid citric acid 2968PHW8QP relief of oral discomfort

citric acid citric acid 2968PHW8QP weight control

Citric Acid Anhydrous Citric Acid Anhydrous 77-92-9 USP Citrulline (L) Citrulline (L) Not USP citrus pectin citrus pectin 47EQO8LE7H digestive aid

clioquinol clioquinol 7BHQ856EJ5 antifungal

clioquinol (lodochlorhydroxyquin) clioquinol 7BHQ856EJ5 antifungal (lodochlorhydroxyquin)

Clobetasol Propionate Clobetasol Propionate 25122-46-7 USP

Page 69 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

cloflucarban cloflucarban I5ZZY3DC5G antimicrobial

Clomipramine Hydrochloride Clomipramine Hydrochloride 17321-77-6 Powder USP

Page 70 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

clonazePAM Clonazepam Tablet, Powder FDA approved product Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 337- 338.

cloNIDine Clonidine Tablet, Powder FDA approved product Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 338- 341.

Clopidogrel Clopidogrel Tablet, Powder FDA approved product Maltz LA, Gauvreau K, Conner JA, et al. Clopidogril in Pediatric Population: Prescribing Practice and Outcomes From a Single Center. Pediatr Cardiol. 2009; 30(2): 99-105.

clortimazole clortimazole G07GZ97H65 n/a

Clotrimazole Clotrimazole 23593-75-1 Powder USP clotrimazole clotrimazole G07GZ97H65 antifungal

Page 71 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

clove oil clove oil 578389D6D0 skin protectant astringent

cloxyquin (chlorhydroxyquinoline) cloxyquin BPF36H1G6S acne (chlorhydroxyquinoline)

cnicus benedictus cnicus benedictus 6L5ZL09795 menstrual/diuretic

cnicus benedictus cnicus benedictus 6L5ZL09795 weight control

coal tar coal tar R533ES02EC acne

coal tar coal tar R533ESO2EC antifungal

coal tar coal tar R533ESO2EC dandruff

coal tar coal tar R533ESO2EC dandruff psoriasis

coal tar coal tar R533ESO2EC dandruff seborrheic dermatitis

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Cobalt Chloride Hexahydrate Cobalt Chloride Hexahydrate Not USP

Cobalt Gluconate Cobalt Gluconate Not USP Cocoa butter Theobroma Oil Not USP unless by another name cocoa butter cocoa butter 5120YT1CRR anorectal protectant

cocoa butter cocoa butter 512OYT1CRR skin protectant

cocoa butter cocoa butter 512OYT1CRR skin protectant diaper rash

cocoa butter cocoa butter 512OYT1CRR skin protectant fever blister/cold sore

Coconut Oil Edible Coconut Oil Edible NF coconut oil soap, aqueous coconut oil soap, aqueous pediculicide

Cod Liver Oil Cod Liver Oil 8001-69-2 Oil USP cod liver oil cod liver oil BBL281NWFG anorectal wound healing

Page 73 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

cod liver oil cod liver oil BBL281NWFG cough/cold antitussive

cod liver oil cod liver oil BBL281NWFG skin protectant diaper rash

cod liver oil (in combination) cod liver oil (in combination) BBL281NWFG anorectal protectant

codeine codeine Q830PW7520 cough/cold antitussive

codeine codeine Q830PW7520 internal analgesic

codeine codeine Q830PW7520 menstrual/diuretic analgesic

codeine phosphate codeine phosphate GSL05Y1MN6 cough/cold antitussive

codeine phosphate codeine phosphate GSL05Y1MN6 internal analgesic

codeine sulfate codeine sulfate 11QV9BS0CB cough/cold antitussive

Page 74 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

codeine sulfate codeine sulfate 11QV9BS0CB internal analgesic

Coenyme Q10 Ubidecarenone; Ubiquinone- 303-98-0 Powder Not USP unless by another 50; 2-Deca(3-methylbut-2- name enylene)-5,6-dimethoxy-3- methyl-p-benzoquinone

Coenzyme Q50 Ubiquinone-50 USP has Coenzyme Q9 in Reagents: C Collagenase Collagenase USP talks about its use in <123> Glucagon Bioidentity tests

collinsonia (extract stone root) collinsonia (extract stone J9BTD5377V menstrual/diuretic root)

collinsonia extrat collinsonia extrat IOS9HV04K7 anorectal other

Collodion Collodion NDC 51552- Liquid USP 0203-6

Page 75 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Collodion Topical Mix Collodion Liquid USP

colloidal oatmeal colloidal oatmeal 8PI54V663Y dandruff

colloidal oatmeal colloidal oatmeal 8PI54V663Y skin protectant

Page 76 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

colloidal oatmeal colloidal oatmeal 8PI54V663Y skin protectant astringent

colloidal oatmeal colloidal oatmeal 8PI54V663Y skin protectant diaper rash

colocynth colocynth 23H32AOH17 laxative bulk laxative

Colophony (2R,3S,4S,5R,6R)-2- 8050-9-7 and BP, JP, PhEur Rowe RC, Sheskey PJ, Cook WG, Quinn ME, (Hydroxymethyl)-6-[(E)-3- 8050-10-0 eds. Handbook of Pharmaceutical Excipients. phenylprop-2-enoxy]oxane- 7th ed. London, UK. Pharmaceutical Press div 3,4,5-triol Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Copper Copper Not USP unless by another name copper copper 789U1901C5 weight control

Copper Bisglycinate Copper Bisglycinate Not USP unless by another name copper gluconate copper gluconate 789U1901C5 weight control

copper oleate copper oleate 789U1901C5 pediculicide

Page 77 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

copper undecylenate copper undecylenate 789U1901C5 antifungal

Corn Oil Corn Oil Refined 8001-30-7 Liquid NF corn oil corn oil 8470G57WFM weight control

corn oil, aqueous emulsion corn oil, aqueous emulsion cholecystokinetic

corn silk corn silk 7D3VB244UX menstrual/diuretic

corn silk, potassium extract corn silk, potassium extract weight control

Corn Starch Corn Starch Not USP unless by another name corn starch corn starch O8232NY3SJ skin protectant

Corn Starch and Pregelatinized Corn Starch and N/A Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Starch Pregelatinized Starch name eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

corn syrup corn syrup 9G5L16BK6N weight control

Corticotrophin Corticotrophin 9002-60-2 USP Cottonseed Oil Cottonseed Oil 8001-29-4 Oil USP, NF? couch grass couch grass 8K1MK5E1FY menstrual/diuretic

Creatine, Monohydrate N-Guanyl-N-methylglycine; 6020-87-7 Powder Not USP unless by another N-Amidinosarcosine name

creosote creosote relief of oral discomfort

creosote creosote skin protectant poison ivy/oak/sumac

creosote, beechwood creosote, beechwood cough/cold antitussive

creosote, beechwood creosote, beechwood external analgesic poison ivy/oak/sumac

creosote, beechwood creosote, beechwood relief of oral discomfort

creosote, beechwood (oral) creosote, beechwood (oral) cough/cold nasal decongestant

Page 79 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

creosote, beechwood (topical) creosote, beechwood cough/cold nasal decongestant (topical)

cresol cresol 1MXY2UM8NV oral health care

cresol cresol 1MXY2UM8NV oral health care anesthetic/analgesic

cresol cresol 1MXY2UM8NV relief of oral discomfort

cresol cresol 1MXY2UM8NV skin astringent

cresol, saponated cresol, saponated 1MXY2UM8NV dandruff

Cucumber Melon Fragrance Cucumber Melon Fragrance Not USP

cupric sulfate cupric sulfate LRX7AJ16DT weight control

Page 80 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

cupric sulfate cupric sulfate LRX7AJ16DT external analgesic

cupric sulfate cupric sulfate LRX7AJ16DT skin protectant astringent

Curcumin Curcumin 458-37-7 USP cyanocobalamin (vitamin B12) cyanocobalamin (vitamin P6YC3EG204 weight control B12)

Cyclandelate Cyclandelate 456-59-7 USP Federal Register 1999

cyclizine hydrochloride cyclizine hydrochloride W0O1NHP4WE antiemetic

Page 81 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Cyclobenzaprine Hydrochloride Cyclobenzaprine 6202-23-9 USP Hydrochloride cyclomethycaine sulfate cyclomethycaine sulfate 7323N7T136 external analgesic & anesthetic

cyclomethycaine sulfate cyclomethycaine sulfate 7323N7T136 external analgesic fever blister/cold sore

cyclomethycaine sulfate cyclomethycaine sulfate 7323N7T136 external analgesic poison ivy/oak/sumac

Cyclophosphamide Cyclophosphamide 6055-19-2 Injection, USP Powder

Cysteine Cysteine; L-Cysteine 7048-0406 USP Hydrochloride cysteine hydrochloride cysteine hydrochloride ZT934N0X4W skin protectant diaper rash

cystine cystine 48TCX9A1VT weight control

Cytarabine Cytarabine 147-94-4 USP

Page 82 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

danthron danthron Z4XE6IBF3V laxative stimulant laxative

Dantrolene Dantrolene Capsule, FDA approved product Taketomo CK, Hodding JH, Kraus DM. Powder Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 386- 387. Dapsone Dapsone Tablet, Powder FDA approved product Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 387- 389.

datura stramonium datura stramonium cough/cold anticholinergic

Decyl Oleate 9-Octadecenoic acid (0Z)-, 3687-46-5 BP, PhEur Rowe RC, Sheskey PJ, Cook WG, Quinn ME, decyl ester eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Decylmethylsulfoxide Decylmethylsulfoxide Not USP unless by another name Dehydroepiandrosterone (DHEA) DHEA micronized, 53-43-0 Not USP unless by another micronized name Dehydroepiandrosterone, DHEA; Prasterone; 3B- 53-43-0 Powder Not USP unless by another Micronized Hydroxyandrost-5-en-17- name one

Page 83 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

dehyrocholic acid dehyrocholic acid NH5000009I digestive aid

Deoxy-D-Glucose Deoxy-D-Glucose; 2-Deoxy- 154-17-6 Powder USP, Reagent D-Glucose dequalinium chloride dequalinium chloride XYS8INN1I6 oral health care

Desonide Desonide Not USP unless by another name Dexamethasone Acetate Dexamethasone Acetate 1177-67-3? Powder USP Micronized Anhydrous Micronized Anhydrous

dexbromopheniramine dexbromopheniramine BPA9UT29BS cough/cold antihistamine

dexchlorpheniramine maleate dexchlorpheniramine B10YD955QW cough/cold antihistamine maleate

dexpanthenol dexpanthenol 1O6C93RI7Z external analgesic

dexpanthenol dexpanthenol 1O6C93RI7Z external analgesic poison ivy/oak/sumac

dexpanthenol dexpanthenol 1O6C93RI7Z skin protectant

Page 84 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

dextran 70 dextran 70 7SA290YK68 ophthalmic demulcents

dextromethorphan dextromethorphan 7355X3ROTS cough/cold antitussive

dextromethorphan hydrobromide dextromethorphan 9D2RTI9KYH cough/cold antitussive hydrobromide

dextrose dextrose IY9XDZ35W2 weight control

Dextrose Anhydrous Dextrose Anhydrous 50-9907 Powder USP

Page 85 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Dextrose Anhydrous Dextrose Anhydrous 50-9907 Powder USP

Dextrose Anhydrous Dextrose Anhydrous 50-9907 Powder USP, FDA approved injection

Dextrose Hydrous Dextrose Hydrous Powder USP

Page 86 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Diaminopyridine (3,4-) 3, 4-Diaminopyridine 3,4 Not USP Federal Register 1999 Pyridinediamine

diastase diastase digestive aid

diastase malt diastase malt digestive aid

Page 87 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

dibenzothiophene dibenzothiophene Z3D4AJ1R48 acne

dibucaine dibucaine L6JW2TJG99 anorectal local anesthetic

dibucaine dibucaine L6JW2TJG99 external analgesic

dibucaine dibucaine L6JW2TJG99 oral health care anesthetic/analgesic

dibucaine hydrochloride dibucaine hydrochloride Z97702A5DG anorectal local anesthetic

dibucaine hydrochloride dibucaine hydrochloride Z97702A5DG external analgesic

dibucaine hydrochloride dibucaine hydrochloride Z97702A5DG oral health care anesthetic/analgesic

Dibutyl Squarate Dibutyl Squarate Not USP unless by another name dicalcium phosphate dihydrate dicalcium phosphate O7TSZ97GEP anticaries dentrifrices dihydrate

Page 88 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

dicalcium phosphate dihydrate dicalcium phosphate O7TSZ97GEP gingivitis/plaque [see calcium dibasic phosphate) dihydrate [see calcium dibasic phosphate)

Dichloroacetic Acid Dichlorethanoic Acid; DCA; 79-43-6 Liquid Reagent BCA; Bichloroacetic Acid

dichlorodiphenyl trichloroethane dichlorodiphenyl pediculicide (DDT) trichloroethane (DDT)

dichlorophen dichlorophen T1J0JOU64O antifungal

Diclofenac Sodium Diclofenac Sodium 15307-79-6 USP, BP Diethyl Sebacate Diethyl decanedioate 110-40-7 USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

diethylhexyl butamido triazon diethylhexyl butamido 2UTZ0QC864 sunscreen triazon

Difluoroethane (HFC) 1,1-Difluoroethane 75-37-6 Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

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digalloyl trioleate digalloyl trioleate PGQ9BY2MDE sunscreen

dihydroxyaluminum dihydroxyaluminum D0250MG0W6 antacid aminoacetate aminoacetate

dihydroxyaluminum aminoacetic dihydroxyaluminum D0250MG0W6 antacid acid aminoacetic acid

dihydroxyaluminum sodium dihydroxyaluminum sodium 84H8Z9550J antacid carbonate carbonate

dihydroxyaluminum sodium dihydroxyaluminum sodium 84H8Z9550J digestive aid carbonate carbonate

Diindolylmethane (3,3) Diindolylmethane (DIM) Not USP Diloxanide furoate Diloxanide furoate 3735-81-0 USP Federal Register 1999

dimenhydrinate dimenhydrinate JB937PER5C antiemetic

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Dimercapto-1-propanesulfonaic Dimercapto-propanesulfonic Not USP unless by another Federal Register 1999 acid acid(DL-2,3)Na salt name

Dimercaptosuccinic acid (Meso- DMSA; Succimer; meso-2,3- 304-55-2 Powder Not USP 2,3) Dimercaptosuccinic Acid

dimethicone dimethicone 92RU3N3Y1O skin protectant

dimethicone dimethicone 92RU3N3Y1O skin protectant diaper rash

dimethicone dimethicone 92RU3N3Y1O skin protectant fever blister/cold sore

dimethisoquin hydrochloride dimethisoquin hydrochloride SMP2689462 external analgesic

Dimethyl Ether Methoxymethane 115-10-6 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, name eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

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Dimethyl Ketone Dimethyl Ketone Not USP unless by another name Dimethyl Phthalate 1,2-Benzenedicarboxylic 131-11-3 BP, Diethyl Phthalate is in USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, acid, dimethyl esther as a solvent eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Dimethyl Sulfone Methylsulfonylmethane; 67-71-0 Powder USP has monograph for MSM; DMSO2 Dimethyl Sulfoxide Dimethylacetamide N,N-Dimethylacetamide 127-19-5 Liquid BP, PhEur; Listedin USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, monograph for Hydroxypropyl eds. Handbook of Pharmaceutical Excipients. Betadex Ether stock solution. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Dimethylaminoethanol Bitartrate Deanol Bitartrate; DMAE 5988-51-2 Powder Not USP Bitartrate Dimethylaminoethanol Complex DMAE Complex 38% (w/v) Not USP 38% (w/v) Dimethylglycine Hydrochloride Dimethylglycine Not USP Hydrochloride

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Dinitrochlorobenzene Dinitrochlorobenzene Not USP Federal Register 1999

dioctyl sodium sulfosuccinate dioctyl sodium F05Q2T2JA0 pediculicide sulfosuccinate

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diolamine methoxycinnamate diolamine sunscreen (diethanolamine methoxycinnamate methoxycinnamate) (diethanolamine methoxycinnamate) dioxybenzone dioxybenzone B762XZ551X sunscreen

diperodon diperodon 2456GO94TR anorectal anesthetic

diperodon hydrochloride diperodon hydrochloride 5YZ5R8I73Y corn/callus remover

diperodon hydrochloride diperodon hydrochloride 5YZ5R8I73Y external analgesic poison ivy/oak/sumac

diperodon hydrochloride diperodon hydrochloride 5YZ5R8I73Y skin protectant poison ivy/oak/sumac

diphenhydramine citrate diphenhydramine citrate 8GTS82S83M cough/cold antihistamine

diphenhydramine citrate diphenhydramine citrate 8GTS82S83M cough/cold antitussive

diphenhydramine citrate diphenhydramine citrate 8GTS82S83M nighttime sleep aid

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diphenhydrochlorideramine diphenhydrochlorideramine TC2D6JAD40 antiemetic hydrochloride hydrochloride

diphenhydrochlorideramine diphenhydrochlorideramine TC2D6JAD41 cough/cold antihistamine hydrochloride hydrochloride

diphenhydrochlorideramine diphenhydrochlorideramine TC2D6JAD42 cough/cold antitussive hydrochloride hydrochloride

diphenhydrochlorideramine diphenhydrochlorideramine TC2D6JAD43 external analgesic hydrochloride hydrochloride

diphenhydrochlorideramine diphenhydrochlorideramine TC2D6JAD44 nighttime sleep aid antihistamine hydrochloride hydrochloride

diphenhydrochlorideramine diphenhydrochlorideramine TC2D6JAD45 skin protectant poison ivy/oak/sumac hydrochloride hydrochloride

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Diphenylcyclopropenone Diphenylcyclopropenone; 886-38-4 Powder Van der Steen PH, Van Baar HM, Perret CM, DPCP Happle R. Treatment of Alopecia Areata with Diphenylcyclopropenone. J Am Acad Dermatol. 24:253-7, 1991 Feb.

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Dipropylene Glycol 3 isomers and a mixture: 110-98-5; 108- Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, 1,1'-Oxybis(2-propanol); 2,2'- 61-2; 106-62- name eds. Handbook of Pharmaceutical Excipients. Oxybis(1-propaol); 2-(2- 7; 25265-71-8 7th ed. London, UK. Pharmaceutical Press div Hydroxypropoxy)propanol; Royal Pharmaceutical Society of Great Britain Oxybispropanol and Washington, DC. American Pharmacists Association; 2012.

dipropylene glycol salicylate dipropylene glycol salicylate sunscreen

Dipyridamole Dipyridamole Tablet, Powder FDA approved product

disodium hydrogen phosphage disodium hydrogen anticaries phosphage

Disodium Hydrogen Phosphate Disodium Hydrogen Not USP unless by another Phosphate name Disodium Phosphate Disodium Phosphate Not USP unless by another name DL-Methionine Racemethionine 59-51-8 Powder USP DL-Phenylalanine DL-Phenylalanine 150-30-1 Powder Not USP, L-Phenylalanine is USP

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D-Mannose (3S,4S,5S,6R)-6- 3458-28-4 USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, (hydroxymethyl)oxane- eds. Handbook of Pharmaceutical Excipients. 2,3,4,5-tetrol 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Docosanol(1-) Behenyl alcohol 661-19-8 Not USP docusate calcium sulfosuccinate docusate calcium 6K7YS503HC laxative stool softener sulfosuccinate

docusate potassium docusate potassium CIK9F54ZHR laxative stool softener sulfosuccinate sulfosuccinate

docusate sodium docusate sodium F05Q2T2JA0 pediculicide

docusate sodium docusate sodium F05Q2T2JA0 weight control

Docusate Sodium 85% Docusate Sodium 85% 577-11-7 USP docusate sodium sulfosuccinate docusate sodium F05Q2T2JA0 laxative stool softener sulfosuccinate

dodecaethylene glycol dodecaethylene glycol vaginal contraceptive monolaurate (polyethylene monolaurate (polyethylene glycol) 60 monolau glycol) 60 monolau

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Dodecyl Gallate Dodecyl 3,4,5- 1166-52-5 BP, PhEur; USP has Propyl Rowe RC, Sheskey PJ, Cook WG, Quinn ME, tryhydroxybenzoate Gallate eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

dog grass dog grass 8K1MK5E1FY digestive aid

dog grass extract dog grass extract 8K1MK5E1FY menstrual/diuretic

Domeperidone Domeperidone 57808-66-9 BP, USP monograph in progress Motilium in other countries

domiphen bromide domiphen bromide R4CY19YS7C oral health care

doxylamine succinate doxylamine succinate V9BI9B5YI2 cough/cold antihistamine

doxylamine succinate doxylamine succinate V9BI9B5YI2 nighttime sleep aid antihistamine

drometrizole trisiloxane drometrizole trisiloxane 5X93W9OFZL sunscreen

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duodenal substance duodenal substance digestive aid

dyclonine hydrochloride dyclonine hydrochloride ZEC193879Q anorectal local anesthetic

dyclonine hydrochloride dyclonine hydrochloride ZEC193879Q externalan algesic

dyclonine hydrochloride dyclonine hydrochloride ZEC193879Q oral health care anesthetic/analgesic

Dyphylline Dyphylline 479-18-5 USP ecamsule ecamsule M94R1PM439 sunscreen

Edetate acid ethylene diamine Edetic Acid? 60-00-4? USP if the right stuff tetraacetic acid (EDTA)

Edetate calcium disodium Edetate calcium disodium 23411-34-9 USP

edetate disodium edetate disodium 7FLD91C86K relief of oral discomfort

Edetate tetrasodium tetrahydrate Edetate tetrasodium Not USP tetrahydrate elaterin resin elaterin resin laxative stimulant laxative

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elecampane elecampane E55SMD6DA8 digestive aid

elm bark elm bark 91QY4PXU8Q cough/cold antitussive

elm bark elm bark 91QY4PXU8Q oral health care demeculents

Enalapril Enalapril Maleate 76095-16-4 Tablet, Powder USP, FDA approved product Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 499- 503.

Enrofloxacin Enrofloxacin 93106-60-6 Powder USP ensulizole (phenylbenzimidazole ensulizole 9YQ9DI1W42 sunscreen sulfonic acid) (phenylbenzimidazole sulfonic acid)

enzacamene (4- enzacamene (4- 8I3XWY40L9 sunscreen methylbenzylidene camphor) methylbenzylidene camphor)

ephedrine ephedrine GN83C131XS cough/cold bronchodilator

ephedrine (aqueous) ephedrine (aqueous) GN83C131XS cough/cold nasal decongestant

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ephedrine (jelly) ephedrine (jelly) GN83C131XS cough/cold nasal decongestant

ephedrine (oral) ephedrine (oral) GN83C131XS cough/cold nasal decongestant

ephedrine hydrochlorid (oral) ephedrine hydrochlorid NLJ6390P1Z cough/cold nasal decongestant (oral)

ephedrine hydrochloride ephedrine hydrochloride NLJ6390P1Z cough/cold bronchodilator

ephedrine hydrochloride ephedrine hydrochloride NLJ6390P1Z external analgesic male genital desensitizer

ephedrine hydrochloride ephedrine hydrochloride NLJ6390P1Z ophthalmic vasoconstrictor

ephedrine hydrochloride ephedrine hydrochloride NLJ6390P1Z cough/cold nasal decongestant (aqueous) (aqueous)

ephedrine hydrochloride (jelly) ephedrine hydrochloride NLJ6390P1Z cough/cold nasal decongestant (jelly)

ephedrine sulfate ephedrine sulfate U6X61U5ZEG anorectal vasoconstrictor

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ephedrine sulfate ephedrine sulfate U6X61U5ZEG cough/cold bronchodilator

ephedrine sulfate (aqueous) ephedrine sulfate (aqueous) U6X61U5ZEG cough/cold nasal decongestant

ephedrine sulfate (jelly) ephedrine sulfate (jelly) U6X61U5ZEG cough/cold nasal decongestant

ephedrine sulfate (oral) ephedrine sulfate (oral) U6X61U5ZEG cough/cold nasal decongestant

epinephrine epinephrine YKH834O4BH anorectal vasoconstrictor

epinephrine epinephrine YKH834O4BH cough/cold bronchodilator

epinephrine bitartrate epinephrine bitartrate 30Q7KI53AK cough/cold bronchodilator

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epinephrine hydrochloride epinephrine hydrochloride WBB047OO38 anorectal vasoconstritor

epinephrine hydrochloride epinephrine hydrochloride WBB047OO38 cough/cold bronchodilator

epinephrine undecylenate epinephrine undecylenate anorectal vasoconstrictor

ergocalciferol ergocalciferol VS041H42XC weight control

ergot fluid extract ergot fluid extract X3S33EX3KW skin protectant insect bites/stings

ergot fluidextract ergot fluidextract X3S33EX3KW external analgesic insect bite/sting

Escherichia coli vaccine Escherichia coli vaccine 514B9K0L10 anorectal other

estrone estrone 2DI9HA706A acne

Ethanolamine 2-Aminoethanol 141-43-5 Not USP unless by another name

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ether ether 0F5N573A2Y digestive aid

ethohexadiol ethohexadiol M9JGK7U88V dandruff

Ethoxy Diglycol Diethylene Glycol 111-90-0 Liquid USP Monoethyl Ether; Carbitol; 2- (2-Ethoxyethoxy) ethanol

ethyl 4-[bis(hydroxypropyl] ethyl 4-[bis(hydroxypropyl] 54M9O25201 sunscreen aminobenzoate (roxadimate) aminobenzoate (roxadimate)

Ethyl Lactate 2-Hydroxy-propanoic acid 97-64-3 Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, ethyl ester eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

ethyl nitrate ethyl nitrate E1ZT886LR5 menstrual/diuretic

Ethylene Vinyl Acetate Ethylene vinyl acetate 24937-78-8 Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, copolymer eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

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Ethylenediaminetetraacetic Acid Ethylenediaminetetraacetic Not USP unless by another Disodium Salt Acid Disodium Salt name ethylmorphine hydrochloride ethylmorphine MFM5450P3T cough/cold antitussive hydrochloride

Etoposide Etoposide Injection Liquid FDA approved product Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 551- 552.

eucalyptol eucalyptol RV6J6604TK cough/cold antitussive

eucalyptol eucalyptol RV6J6604TK dandruff

eucalyptol eucalyptol RV6J6604TK oral health care anesthetic/analgesic

eucalyptol (lozenge) eucalyptol (lozenge) RV6J6604TK cough/cold nasal decongestant

eucalyptol (mouth) eucalyptol (mouth) RV6J6604TK cough/cold nasal decongestant

eucalyptol/eucalyptus oil eucalyptol/eucalyptus oil 2R04ONI662 cough/cold expectorant

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eucalyptus oil eucalyptus oil 2R04ONI663 cough/cold antitussive

eucalyptus oil eucalyptus oil 2R04ONI664 cough/cold antitussive

eucalyptus oil eucalyptus oil 2R04ONI665 cough/cold antitussive

eucalyptus oil eucalyptus oil 2R04ONI666 cough/cold nasal decongestant

eucalyptus oil eucalyptus oil 2R04ONI667 external analgesic counter irritant

eucalyptus oil eucalyptus oil 2R04ONI668 external analgesic fever blister/cold sore

eucalyptus oil eucalyptus oil 2R04ONI669 external analgesic poison ivy/oak/sumac

eucalyptus oil eucalyptus oil 2R04ONI670 skin protectant astringent

eucalyptus oil eucalyptus oil 2R04ONI671 skin protectant poison ivy/oak/sumac

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eucalyptus oil (lozenge) eucalyptus oil (lozenge) 2R04ONI672 cough/cold nasal decongestant

eucalyptus oil (mouthwash) eucalyptus oil (mouthwash) 2R04ONI673 cough/cold nasal decongestant

eugenol eugenol 3T8H1794QW external analgesic & anesthetic

eugenol eugenol 3T8H1794QW external analgesic fever blister/cold sore

eugenol eugenol 3T8H1794QW external analgesic poison ivy/oak sumac

eugenol eugenol 3T8H1794QW relief of oral discomfort

eugenol eugenol 3T8H1794QW skin protectant astringent

eulcalyptol eulcalyptol RV6J6604TK cough/cold antitussive

euphorbia pilulifera euphorbia pilulifera L13YF113GN cough/cold bronchodilator

Fenbendazole Fenbendazole 43210-67-9 USP, EP

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fennel acid fennel acid digestive aid

ferric acid ferric acid skin protectant poison ivy/oak/sumac

ferric ammonium citrate ferric ammonium citrate UVP74NG1C5 weight conrol

ferric chloride ferric chloride U38V3ZVV3V external analgesic insect bite/sting

ferric chloride ferric chloride U38V3ZVV3V menstrual/diuretic

ferric chloride ferric chloride U38V3ZVV3V oral health care

ferric chloride ferric chloride U38V3ZVV3V skin protectant insect bites/stings

ferric pyrophosphate ferric pyrophosphate QK8899250F weight control

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Ferric subsulfate Ferric Sulfate, Basic 1310-45-8 Powder Not USP unless by another Federal Register 1999 name

ferric subsulfate (Monsel's ferric subsulfate (Monsel's 3QJ8WS6V8H skin protectant astringent solution) solution)

Ferric sulfate hydrate Ferric sulfate hydrate Not USP unless by another Federal Register 1999 name

Ferric Sulfate Solution Ferric Sulfate Solution Not USP unless by another name ferrous fumarate ferrous fumarate R5L488RY0Q weight control

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ferrous gluconate ferrous gluconate U1B11I423Z weight control

ferrous sulfate ferrous sulfate 39R4TAN1VT menstrual/diuretic

ferrous sulfate (iron) ferrous sulfate (iron) 39R4TAN1VT weight control

Ferulic Acid trans-4-hydroxy-3-meth- 1135-24-6 USP oxycinnamic acid flax seed flax seed 4110YT348C weight control

Flecainide Flecainide Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 582- 583.

Fluconazole Fluconazole 86366-73-4 Powder USP, FDA approved tablet and Taketomo CK, Hodding JH, Kraus DM. powder for oral suspension. Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010. Flucytosine Flucytosine Tablet, Powder FDA approved product Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 586- 587.

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Fludrocortisone Fludrocortisone Tablet, Powder FDA approved product Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 589- 590.

fluorosalan fluorosalan 80OFG3WPYD antimicrobial

Flurbiprofen [1,1c-Biphenyl]-4-acetic 5104-49-4 USP acid, 2-fluoro-alpha-methyl-,

Folic Acid Folic Acid Injection, FDA approved product Taketomo CK, Hodding JH, Kraus DM. Powder Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 619- 620. Folic Acid Vitamin M or Vitamin Bc 59-30-3 USP folic acid folic acid 935E97BOY8 weight control

Folinic Acid Calcium Salt Folinic Acid Calcium Salt not usp

formaldehyde solution formaldehyde solution 1HG84L3525 relief of oral discomfort

formic acid formic acid 0YIW783RG1 pediculicide

Formoterol Fumarate Dihydrate Formoterol Fumarate 43229-80-7 Powder Not USP Dihydrate

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

frangula frangula S2D77IH61R laxative stimulant laxative

fructose fructose 6YSS42VSEV overindulgence in a inebriation minimizer

fructose fructose 6YSS42VSEV weight control

Fructose and Pregelatinized Fructose USP 57-48-7 USP has a Fructose monograph Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Starch and NF monographs for eds. Handbook of Pharmaceutical Excipients. Pregelatinized Hydroxypropyl 7th ed. London, UK. Pharmaceutical Press div Corn, Pean and Potato Starch Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Gabapentin Gabapentin 60142-96-3 USP galega galega BIA2SO6F5B digestive aid

gamboge gamboge 7556HJ7587 laxative stimulant laxative

Gamma Aminobutyric Acid 4-Aminobutyric Acid 56-12-2 USP, Reagent garlic, dehydrated garlic, dehydrated V1V998DC17 digestive aid

Page 116 of 1183 25 February 2014

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gelatin gelatin 2G86QN327L ophthalmic demulcents

gelatin gelatin 2G86QN327L oral heal care demeculcents

Gentamicin Gentamicin sulfate 1405-41-0 USP, BP gentian violet gentian violet J4Z741D6O5 oral health care

Gentian Violet 1% Solution Gentian Violet Powder, FDA approved product Solution

gentian voilet gentian voilet J4Z741D6O5 anthelmintic

gentiana lutea (gentian) gentiana lutea (gentian) S72O3284MS menstrual/diuretic

Germanium sesquinoxide Germanium sesquinoxide USP Dimethicone monograph talke about an assay procedure for germanium

GHRP-2 GHRP-2 ? GHRP-6 GHRP-6 ? ginger ginger C5529G5JPQ digestive aid

Ginger root powder Ginger root powder USP has powdered ginger but not CAS #

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Ginko Biloba Standardized Extract Ginko Biloba Standardized Powder USP has Ginkgolic Acids and Extract Ginko Terpene Lactones

ginseng ginseng ZQH6VH092Z nighttime sleep aid

ginseng ginseng ZQH6VH092Z stimulant

Gluconic Acid Calcium Salt D-Glucuronic Acid is USP? 6556-12-3? Not USP unless by another name glutamic acid hydrochloride glutamic acid hydrochloride 3KX376GY7L digestive aid stomach acidifier

Glutamine Glutamine, L 56-85-9 USP Federal Register 1999

Glutaraldehyde solution Pentane-1,5-dial 111-30-8 Liquid Not USP unless by another name Glutathione Glutathione (L) reduced; L- 70-18-8 Powder USP Glutathione Reduced Form; N-(N-L-gamma-Glutamyl-L- cysteinyl)-glycine; GSH

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Glycerin propane-1,2,3-triol 56-81-5 Liquid USP

glycerin glycerin PDC6A3C0OX anorectal protectant

glycerin glycerin PDC6A3C0OX external analgesic poison ivy/oak/sumac

glycerin glycerin PDC6A3C0OX laxative hyperosmotic

glycerin glycerin PDC6A3C0OX ophthalmic demulucent

glycerin glycerin PDC6A3C0OX oral health care

glycerin glycerin PDC6A3C0OX otic

glycerin glycerin PDC6A3C0OX skin protectant

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glycerin glycerin PDC6A3C0OX skin protectant diaper rash

glycerin glycerin PDC6A3C0OX skin protectant fever blister/cold sore

glycerin glycerin PDC6A3C0OX skin protectant insect bites/stings

Glycerin (Synthetic) Glycerin (Synthetic) USP

Glycerin 99.5% Anhydrous Glycerin 99.5% Anhydrous UPC 03951- Liquid USP 03116 glycerine and anhydrous glycerine glycerine and anhydrous PDC6A3C0OX otic glycerine

glycerine and anhydrous glycerine glycerine and anhydrous PDC6A3C0OX skin protectant diaper rash glycerine

glycerine and anhydrous glycerine glycerine and anhydrous PDC6A3C0OX skin protectant poison ivy/oak/sumac glycerine

Glycerol Formal 1,3-Dioxolane-4-methano; 68442-91-1 Liquid Not USP unless by another Glycerin Formal name

glyceryl aminobenzoate glyceryl aminobenzoate A886B5N5IM sunscreen (lisadimate, glyceryl PABA) (lisadimate, glyceryl PABA)

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Glyceryl Monostearate Glyceryl Monostearate Not USP unless by another name Glyceryl Palmitostearate Octadecanoic acid, 2,3- 8067-32-1 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, dihydroxypropyl ester mixed name eds. Handbook of Pharmaceutical Excipients. with 3-hydroxy-2-[(1- 7th ed. London, UK. Pharmaceutical Press div oxohexadecyl)-oxy] propyl Royal Pharmaceutical Society of Great Britain octadecanoate and Washington, DC. American Pharmacists Association; 2012.

glyceryl stearate glyceryl stearate 230OU9XXE4 skin protectant insect bites/stings w/ sales less than $25,000

glyceryl stearate glyceryl stearate 230OU9XXE4 skin protectant poison ivy/oak/sumac w/ sales less than $25,000

glyceryl stearate glyceryl stearate 230OU9XXE4 skin protectant w/ sales less than $25,000

Glycine Glycine; L-Glycine 58-40-6 USP glycine glycine TE7660XO1C antidiarrheal

glycine glycine TE7660XO1C digestive aid

glycine (aminoacetic acid) glycine (aminoacetic acid) TE7660XO1C antacid

Page 121 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Glycofurol alpha-[(Tetrahydro-2- 31692-85-0 Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, furanyl)methyl]-w-hydroxy- eds. Handbook of Pharmaceutical Excipients. poly(oxy-1,2-ethane-diyl) 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

glycol salicylate glycol salicylate external analgesic fever blister/cold sore

glycol salicylate glycol salicylate external analgesic poison ivy/oak/sumac

Glycolic Acid Hydroxyacetic Acid; 79-14-1 Crystal, Not USP unless by another Hydroxyethanoic Acid Granula name Glycolic Acid, 70% Glycolic Acid, 70% 79-14-1 Solution Not USP unless by another name glycyrrhiza (licorice) glycyrrhiza (licorice) 61ZBX54883 menstrual/diuretic

Glydiazinamide Glydiazinamide Not USP gramicidin gramicidin 5IE62321P4 first aid antibiotic

Granisetron Granisetron Hydrochloride Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 653- 655.

Grape Seed Oil Grape Seed Oil 222838-60-0? USP has Grape Seeds Oligomeric Proanthocyanidins

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Green Tea Powder Extract Powdered Decaffeinated 84650-60-2 USP Green Tea Extract

Griseofulvin, Micronized (2S)-trans-7-Chloro-2',4,6,- 126-07-8 Powder USP trimethoxy-6'- methylspiro[benzofuran- 2(3H),1'-(2)cyclohexene]- 3,4'dione

Guaiacol Guaiacol 90-05-1 USP Federal Register 1999

Guaifenesin Guaifenesin 93-14-1 USP guaifenesin guaifenesin 495W7451VQ cough/cold expectorant

guar gum guar gum E89I1637KE laxative bulk laxative

guar gum guar gum E89I1637KE weight control

Gum Arabic Gum Arabic ? haloprogin haloprogin AIU7053OWL antifungal

Page 123 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

hard fat hard fat 8334LX7S21 anorectal protectant

hard fat hard fat 8334LX7S21 skin protectant

Hectorite Hectorite 12173-47-6 Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

hectorite hectorite digestive aid

hectorite hectorite external analgesic poison ivy/oak/sumac

hectorite hectorite skin protectant poison ivy/oak/sumac

hemicellulase hemicellulase digestive aid

Page 124 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Heptafluoropropane (HFC) 1,1,1,2,3,3,3- 431-89-0 Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Hepafluoropropane eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

hexachlorophene hexachlorophene IWW5FV6NK2 antimicrobial

Hexetidine 1,3-bis(2-Ethylhexyl)-5- 141-94-6 Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, methylhexahydro-- eds. Handbook of Pharmaceutical Excipients. pyrimidinamine 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

hexylresorcinol hexylresorcinol R9QTB5E82N external analgesic & anesthetic

hexylresorcinol hexylresorcinol R9QTB5E82N external analgesic fever blister/cold sore

hexylresorcinol hexylresorcinol R9QTB5E82N external analgesic poison ivy/oak/sumac

hexylresorcinol hexylresorcinol R9QTB5E82N oral health care anesthetic/analgesic

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hexylresorcinol hexylresorcinol R9QTB5E82N antimicrobial

Histadine, L monohydrochloride Histadine 71-00-1 USP

Page 126 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

histamine dihydrochloride histamine dihydrochloride 3POA0Q644U external analgesic fever blister/cold sore

Histidine Histidine; L-Histidine 70-00-1 usp histidine histidine 4QD397987E weight control

hlorhydroxy complex hlorhydroxy complex aluminum c skin protectant astringent

hlorohydrex hlorohydrex aluminum c acne

hlorohydrex polyethylene glycol hlorohydrex polyethylene aluminum c antiperspirant glycol

hlorohydrex propylene glycol hlorohydrex propylene aluminum c antiperspirant glycol

homatropine methylbromide homatropine 68JRS2HC1C antidiarrheal methylbromide

homatropine methylbromide homatropine 68JRS2HC1C digestive aid methylbromide

homatropine methylbromide homatropine 68JRS2HC1C menstrual/diuretic muscle relaxant methylbromide

Page 127 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

homosalate homosalate V06SV4M95S sunscreen

honey honey Y9H1V576FH skin protectant

horehound horehound 7A72MUN24Z cough/cold antitussive

horehound horehound 7A72MUN24Z oral health care expectorant

horehound horehound 7A72MUN24Z cough/cold expectorant

horsetail horsetail SC52PT1846 digestive aid

huckleberry diges huckleberry diges 9P2U39H18W digestive aid

Hyaluronic Acid Sodium Salt Sodium Hyaluronate 9067-32-7 Powder USP has hyaluronidase for injection but no substance monograph, EP Hyaluronidase, salt free Hyaluronidase, salt free Not USP

Page 128 of 1183 25 February 2014

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hydrALAZINE Hydralazine Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 680 - 682.

hydrastis hydrastis 658O6T0WXZ anorectal antiseptic

hydrastis hydrastis 658O6T0WXZ anorectal counterritant

hydrastis canadensis hydrastis canadensis S1EFO94F35 weight control

hydrastis canadensis (golden seal) hydrastis canadensis (golden ZW3Z11D0JV digestive aid seal)

hydrastis canadensis (golden seal) hydrastis canadensis (golden ZW3Z11D0JV menstrual/diuretic seal)

hydrastis fluid extract hydrastis fluid extract 1E8C2W13Z0 digestive aid

hydrate magnesium aluminate hydrate magnesium antacid activated sulfate aluminate activated sulfate

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Hydrazine sulfate Hydrazine sulfate Not USP unless by another Federal Register 1999 name

hydrochloric acid hydrochloric acid QTT17582CB digestive aid

Hydrochloric Acid 37% Muriatic Acid; Chlorhydric 7647-01-0 Liquid NF, Reagent, ACS Acid hydrocodone bitartrate hydrocodone bitartrate NO70W886KK cough/cold antitussive

Page 130 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Hydrocortisone Hydrocortisone Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 685- 689.

hydrocortisone hydrocortisone WI4X0X7BPJ external analgesic

hydrocortisone (0.25-5%) hydrocortisone (0.25-5%) WI4X0X7BPJ external analgesic

hydrocortisone (0.5-1%) hydrocortisone (0.5-1%) WI4X0X7BPJ external analgesic

hydrocortisone (combination) hydrocortisone WI4X0X7BPJ anorectal (combination)

hydrocortisone acetate hydrocortisone acetate 3X7931PO74 external analgesic

hydrocortisone acetate hydrocortisone acetate 3X7931PO75 external analgesic

hydrocortisone acetate (0.25- hydrocortisone acetate (0.25- 3X7931PO76 external analgesic 5.0%) 5.0%)

hydrocortisone acetate (0.25- hydrocortisone acetate (0.25- 3X7931PO77 external analgesic 5.0%) 5.0%)

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Hydrocortisone Micronized Hydrocortisone Micronized Powder USP Powder Powder hydrocortisone preparations hydrocortisone preparations dandruff

hydrogen fluoride hydrogen fluoride RGL5YE86CZ anticaries

hydrogen peroxide hydrogen peroxide BBX060AN9V antimicrobial

hydrogen peroxide hydrogen peroxide BBX060AN9V external analgesic poison ivy/oak/sumac

hydrogen peroxide hydrogen peroxide BBX060AN9V oral health care

hydrogen peroxide hydrogen peroxide BBX060AN9V oral health care wound cleaning

hydrogen peroxide hydrogen peroxide BBX060AN9V skin protectant poison ivy/oak/sumac

Page 132 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

hydrogen peroxide and povidone hydrogen peroxide and BBX060AN9V gingivitis plaque iodine povidone iodine

Hydrogen Peroxide and Saline Hydrogen Peroxide 3% Sodium Taketomo CK, Hodding JH, Kraus DM. Chloride for Pediatric Dosage Handbook. 17th ed. Irrigation 0.9% Hudson, Ohio. Lexi-Comp, Inc. 2010: 689. Sterile

hydrogen peroxide and sodium hydrogen peroxide and BBX060AN9V gingivitis/plaque bicarbonate sodium bicarbonate

Hydrogen Peroxide and Water Hydrogen Peroxide 3% Sterile Water Taketomo CK, Hodding JH, Kraus DM. for Irrigation Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 689.

hydrogen peroxide, sodium hydrogen peroxide, sodium BBX060AN9V gingivitis citrate, sodium lauryl sulfate, and citrate, sodium lauryl zinc ch sulfate, and zinc ch

Hydroquinone Hydroquinone Monobenzyl 123-31-9 USP Ether hydroquinone hydroquinone XV74C1N1AE skin bleach

Page 133 of 1183 25 February 2014

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Hydroxychloroquine Hydroxychloroquine Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 694- 695.

hydroxyethylcellulose hydroxyethylcellulose ophthalmic demulcents

Hydroxyethylpiperazine Ethane 2-[4-(2- 7365-45-9 Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Sulfonic Acid Hydroxyethyl)piperazine-1- eds. Handbook of Pharmaceutical Excipients. yl)ethanesulfonic acid 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Hydroxymethylmethyl Cellulose Hydroxyethylmethylcellulos 9032-42-2 NF, BP, PhEur Rowe RC, Sheskey PJ, Cook WG, Quinn ME, e; Hymetellose eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Hydroxypropyl Cellulose Hydroxypropylcellulose 9004-64-2 Powder USP 1500 CPS hydroxypropyl methycellulose hydroxypropyl 273FM27VK1 ophthalmic demulcents methycellulose

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Hydroxyurea Hydroxyurea 127-07-1 Capsule, USP Taketomo CK, Hodding JH, Kraus DM. Powder Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 695- 697.

hyocyamine sulfate hyocyamine sulfate F2R8V82B84 antidiarrheal

hyoscyamine sulfate hyoscyamine sulfate F2R8V82B84 menstrual/diuretic

hypromellose hypromellose 3NXW29V3WO ophthalmic demulcents

ibuprofen ibuprofen WK2XYI10QM analgesic

Page 135 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

ichlorohydrate ichlorohydrate aluminum d antiperspirant

ichlorohydrex polyethylene glycol ichlorohydrex polyethylene aluminum d antiperspirant glycol

ichlorohydrex propylene glycol ichlorohydrex propylene aluminum d antiperspirant glycol

Ichthammol Bituminol 8029-68-3 Powder Not USP unless by another name ichthammol ichthammol corn/callus remover

ICU Bottom Paste Maalox Regular Strength Cholestyramin Sterile Water Aquaphor Original Taketomo CK, Hodding JH, Kraus DM. Antacid e for Oral for Irrigation Pediatric Dosage Handbook, 17th ed. Suspension, Hudson, Ohio, Lexi-Comp, Inc. 2010: 302- USP (4 gram 304. packet)

Idarubicin Hydrochloride Idarubicin Hydrochloride 57852-57-0 USP

impatiens biflora tincture impatiens biflora tincture SY15A62UPX external analgesic poison ivy/oak/sumac

impatiens biflora tincture impatiens biflora tincture SY15A62UPX skin protectant poison ivy/oak/sumac

Page 136 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Indigo Carmine 3,3'-dioxo-2,2'-bis-indolyden- 860-22-0 Powder Not USP unless by another 5,5'-disulfonic acid disodium name salt

Indole-3-carbinol Indole-3-methanol; I3C; 3- 700-06-1 Powder Not USP unless by another Indolylcarbinol name infusion of rose petals infusion of rose petals 969IQC5YJU ophthalmic astringent

Inositol myo-Inositol; meso-Inositol; 87-89-8 Powder USP, FCC (1,2,3,5-trans-4,6)- Cyclohexan-1,2,3,4,5,6- hexol inositol inositol 4L6452S749 weight control

Inositol Hexanicotinate Inositol Niacinate ? Powder NF

iodides (calcium iodide iodides (calcium iodide cough/cold anhydrous, hydroidic acid iodized anhydrous, hydroidic acid lim) iodized lim)

iodine iodine 9679TC07X4 corn/callus remover

iodine iodine 9679TC07X6 oral health care

iodine iodine 9679TC07X7 wart remover

Page 137 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

iodine iodine 9679TC07X5 digestive aid

iodine iodine 9679TC07X8 weight control

iodine complex/phosphate ester iodine complex/phosphate antimicrobial of alkylaryloxy polyethylene ester of alkylaryloxy polyethylene

Page 138 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

iodine tincture iodine tincture 9679TC07X10 antimicrobial

iodine tincture iodine tincture 9679TC07X11 antimicrobial

iodine tincture iodine tincture 9679TC07X4 antimicrobial

iodine tincture iodine tincture 9679TC07X5 antimicrobial

iodine tincture iodine tincture 9679TC07X6 antimicrobial

iodine tincture iodine tincture 9679TC07X7 antimicrobial

iodine tincture iodine tincture 9679TC07X8 antimicrobial

iodine tincture iodine tincture 9679TC07X9 antimicrobial

iodine topical solution iodine topical solution 9679TC07X4 antimicrobial

Page 139 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

iodoantipyrine (idopyrine) iodoantipyrine (idopyrine) V30V6H1QX4 internal analgesic

Iodochlorhydroxyquin Iodochlorhydroxyquin ? Iodoform Iodoform Not USP unless by another Federal Register 1999 name

Iopanoic Acid Iopanoic Acid 96-83-3 Not USP unless by another name ipecac ipecac 62I3C8233L cough/cold expectorant

ipecac fluidextrat ipecac fluidextrat 62I3C8233L cough/cold expectorant

ipecac fluidextrat ipecac fluidextrat 62I3C8233L poison treatment

Page 140 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

ipecac syrup ipecac syrup 62I3C8233L cough/cold expectorant

ipecac syrup ipecac syrup 62I3C8233L emetic

ipecac syrup ipecac syrup 62I3C8233L poison treatment

ipecac tincture ipecac tincture 62I3C8233L poison treatment

ipomea ipomea laxative stimulant laxative

Ipratropium Bromide Ipratropium Bromide 66985-17-9 USP Ipratropium Bromide, Ipratropium Bromide, 22254-24-6 USP, EP monohydrate monohydrate Iron Glycinate Chelate Iron Glycinate Chelate Not USP unless by another name iron ox bile iron ox bile digestive aid

iron oxide iron oxide 1K09F3G675 external analgesic poison ivy/oak/sumac

iron oxide iron oxide 1K09F3G675 skin protectant poison ivy/oak/sumac

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

isobornyl thiocycanoacetate isobornyl thiocycanoacetate pediculicide

Isoleucine Isoleucine; L-Isoleucine 73-32-5 USP isoleucine isoleucine 04Y7590D77 weight control

isopropyl alcohol isopropyl alcohol ND2M416302 alcohols (topical)

isopropyl alcohol isopropyl alcohol ND2M416303 external analgesic poison ivy/oak/sumac

isopropyl alcohol isopropyl alcohol ND2M416304 mercury

isopropyl alcohol isopropyl alcohol ND2M416305 otic

isopropyl alcohol isopropyl alcohol ND2M416306 otic

isopropyl alcohol isopropyl alcohol ND2M416307 skin protectant astringent

isopropyl alcohol isopropyl alcohol ND2M416308 skin protectant poison ivy/oak/sumac

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Isopropyl Isostearate Propan-2-yl 16- 68171-33-5 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, methylheptadecanoate name eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

isopropyl palmitate isopropyl palmitate 8CRQ2TH63M skin protectant insect bites/stings w/ sales less than $25,000

isopropyl palmitate isopropyl palmitate 8CRQ2TH63M skin protectant poison ivy/oak/sumac w/ sales less than $25,000

isopropyl palmitate isopropyl palmitate 8CRQ2TH63M skin protectant w/ sales less than $25,000

Itraconazole Oriconazole 84625-61-6 Powder USP, BP, EP Ivermectin Ivermectin 70288-86-7 USP, BP jalap jalap 4UDO46YBK2 laxative stimulant laxative

johnswort johnswort XK4IUX8MNB digestive aid

junipar tar junipar tar anorectal analgesic, anesthetic, antipruretic

Page 143 of 1183 25 February 2014

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junipar tar junipar tar dandruff

junipar tar junipar tar digestive aid

junipar tar junipar tar external analgesic

juniper oil (oil of juniper) juniper oil (oil of juniper) YNW2QPG8YK menstrual/diuretic

juniper, potassium extract juniper, potassium extract weight control

kaolin kaolin 24H4NWX5C0 anorectal protectant

kaolin kaolin 24H4NWX5C0 antidiarrheal

kaolin kaolin 24H4NWX5CO skin protectant

kaolin kaolin 24H4NWX5CO skin protectant diaper rash

Page 144 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

kaolin, colloidal kaolin, colloidal 24H4NWX5CO digestive aid

Kaolin, Colloidal Powder Kaolin, Colloidal Powder powder Not USP unless by another name Karaya Gum Karaya Gum USP talked about in Tragacanth monograph; FCC

karaya gum karaya gum laxative

karaya gum karaya gum weight control

kelp kelp weight control

Ketoconazole Ketoconazole Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 780 - 781.

Ketotifen Fumarate Ketotifen Hydrogen 345880-14-8 Powder EP, Not USP Fumarate knotgrass knotgrass 64Y2IV7284 digestive aid

Page 145 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Kojic Acid 5-Hydroxy-2(hydroxymethyl)-501-30-4 Powder Not USP unless by another 4H-pyran-4-one; 5-Hydroxy- name 2-hydroxy-methyl-4-pyrone

Labetalol Labetalol Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 999- 1002. lactic acid lactic acid 33X04XA5AT digestive aid

lactic acid lactic acid 33X04XA5AT wart remover

Lactobacillus acidophilis Lactobacillus acidophilis antidiarrheal

Lactobacillus bugaricus Lactobacillus bugaricus antidiarrheal

lactose lactose J2B2A4N98G weight control

lactose lactose J2B2A4N98G digestive aid

Page 146 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Lactose, Monohydrate and Corn Lactose Monohydrate is USP 5989-81-1 USP has a Lactose monograph Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Starch and NF monographs for eds. Handbook of Pharmaceutical Excipients. Pregelatinized Hydroxypropyl 7th ed. London, UK. Pharmaceutical Press div Corn, Pean and Potato Starch Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Lactose, Monohydrate and Lactose Monohydrate is USP 5989-81-1 USP has a Lactose monograph Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Microcrystalline Cellulose and NF monograph for eds. Handbook of Pharmaceutical Excipients. Microcrystalline Cellulose 7th ed. London, UK. Pharmaceutical Press div separately Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Lactose, Monohydrate and Lactose, Monohydrate and Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Povidone Povidone eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Lactose, Monohydrate and Lactose Monohydrate is USP 5989-81-1 USP has a Lactose monograph Rowe RC, Sheskey PJ, Cook WG, Quinn ME, Powdered Cellulose and NF monograph for eds. Handbook of Pharmaceutical Excipients. Powdered Cellulose separately 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Lactose, Spray-Dried Mixture of lactose 59889-81-1; Combo not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, monohydrate; lactose 10039-26-6; eds. Handbook of Pharmaceutical Excipients. monohydrate, cyclic; lactose 64044-51-5 7th ed. London, UK. Pharmaceutical Press div monohydrate, open form Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

L-Alanine Alanine, (L) FCC Sterile Water Introduction to amino acid metabolism for Irrigation essential versus non-essential amino acids inborn errors in amino acid metabolism. http://themedicalbiochemistrypage.org/ami no-acid-metabolism.html Accessed 12-22- 2011.

lanolin lanolin 7EV65EAW6H anorectal protectant

lanolin lanolin 7EV65EAW6H external analgesic poison ivy/oak/sumac

lanolin lanolin 7EV65EAW6H skin protectant

lanolin lanolin 7EV65EAW6H skin protectant diaper rash

lanolin lanolin 7EV65EAW6H skin protectant poison ivy/oak/sumac

Page 148 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

lanolin lanolin 7EV65EAW6H skin protectant poison ivy/oak/sumac

lanolin (in combination) lanolin (in combination) ophthalmic emollient

lanolin alcohols lanolin alcohols anorectal protectant

lanolin anionic derivatives lanolin anionic derivatives ophthalmic

lanolin, anhydrous (in lanolin, anhydrous (in ophthalmic emollient combination) combination)

Lanolin, Hydrous Hydrous lanolin 8020-84-6 BP, JP, PhEur; Lanolin is USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, 8027-33-6; Could it be equal to eds. Handbook of Pharmaceutical Excipients. Modified Lanolin in USP? 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

lappa extract lappa extract anorectal other

L-Aspartic Acid Sodium Salt Monsodium L-Aspartate; 3792-50-5 powder USP CAS = 56-84-8 Sodium Aspartate

Page 149 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

laureth 10S laureth 10S vaginal contraceptive

Lauric Acid Dodecanoic acid 143-07-7 USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

lauryl isoquinolinium bromide lauryl isoquinolinium 09TM5K0O34 dandruff bromide

lavender compound, tincture of lavender compound, 9YT4B71U8P digestive aid tincture of

Lavender Oil oleum Lavandulae 8000-28-0 Oil Not USP unless by another name lawsone (w/ dihydroxyacetone) lawsone (w/ TLH4A6LV1W sunscreen dihydroxyacetone)

L-Carnosine B-Alanyl-L-hystidine 305-84-0 Powder Not USP unless by another name L-Citruline Citrulline (L); N5- 372-75-8 Powder Not USP unless by another (Aminocarbonyl)-L-ornithine name

L-Cysteine Cysteine; L-2-Amino-3- 52-90-4 Powder Not USP, Cysteine is USP 56-89- mercaptopropanoic Acid 3

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

lead acetate lead acetate RX077P88RY external analgesic poison ivy/oak/sumac

lead acetate lead acetate RX077P88RY skin protectant poison ivy/oak/sumac

lecithin lecithin weight control

Lecithin Organogel Lecithin/Isopropyl Palmitate Liquid Not USP unless by another Solution, Lecithin name 50%/Isopropyl Palmitate Solution Lecithin Soya Granular Lecithin Soya Granular 8002-43-5 Powder Not USP unless by another name leptandra extract leptandra extract anorectal other

Leucine Leucine; L-Leucine 61-90-5 USP Leucine Leucine, Acetyl-L-leucine

leucine weight leucine weight GMW67QNF9C weight control

Page 151 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Leucovorin Calcium Leucovorin Calcium 1492-18-8 Tablet, Powder USP, FDA approved product

levmetamfetamine levmetamfetamine Y24T9BT2Q2 cough/cold nasal decongestant

Levodopa and Carbidopa Levodopa and Carbidopa Tablet, Powder FDA approved tablet dosage Lacy CF, Armstrong LL, Goldman MP, Lance form LL. Drug Information Handbook. 20th ed. Hudson, Ohio. Lexi-Comp, Inc. 2011: 267- 270.

Levofloxacin Hemihydrate Levofloxacin Hemihydrate 138199-71-0 Powder USP

Levomenthol Levomenthol Not USP unless by another name Levulose Fructose 57-48-7 Not USP unless by another name

Page 152 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

L-Histidine Monohydrochloride, Histidine, L-alpha-Amino- 5934-29-2 Powder Not USP unless by another Monohydrate 4(or 5)-imidazolepropionic name Aciid Monohydrochloride; L- Histidine Hydrochloride Monohydrate

lidocaine lidocaine 98PI200987 anorectal local anesthetic

lidocaine lidocaine 98PI200988 external analgesic male genital desensitizer

lidocaine lidocaine 98PI200989 external analgesic

lidocaine lidocaine 98PI200990 oral health care anesthetic/analgesic

lidocaine lidocaine 98PI200991 skin protectant poison ivy/oak/sumac

Lidocaine Hydrochloride Lidocaine Hydrochloride 96108-05-0 or Powder USP 685508 lidocaine hydrochloride lidocaine hydrochloride V13007Z41A external analgesic

lidocaine hydrochloride lidocaine hydrochloride V13007Z41A oral health care analgesic

Page 153 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Lidocaine, Epinephrine and Lidocaine Hydrochloride, Powders USP, FCC Eidelman A, Weiss JM, et al. Topical Tetracaine (LET) Epinephrine Bitartrate, anaesthetics for repair of dermal laceration. Tetracaine Hydrochloride, Cochrane Database Syst Rev 2011 Jun 15; (6): Sodium Bisulfite CD005364. Monosodium Salt, Hydroxyethylcellulose (CPS 5000), Methylparaben, and Propylparaben

linden linden CFN6G1F6YK digestive aid

Linoleic Acid (Z,Z)-9,12-Octadecadienoic 60-33-3 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, acid name eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

lipase lipase digestive aid

Liquid Paraffin Parafin Parafin in USP 8002-74-2 Liquid Petrolatum Petrolatum Not USP unless by another name Lisinopril Lisinopril Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 832- 834.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

live yeast cell derivative live yeast cell derivative 3NY3SM6B8U anorectal other

live yeast cell derivative live yeast cell derivative 3NY3SM6B8U anorectal wound healing

live yeast cell derivative live yeast cell derivative 3NY3SM6B8U skin protectant insect bites with sales less than $2

live yeast cell derivative live yeast cell derivative 3NY3SM6B8U skin protectant w/ sales less than $25,000

liver conconcentrate liver conconcentrate weight control

L-Leucine Leucine (L) Powder

L-Methionine Methionine, L-Methionine Ora-Plus Introduction to amino acid metabolism Crystals essential versus non-essential amino acids inborn errors in amino acid metabolism. http://themedicalbiochemistrypage.org/ami no-acid-metabolism.html Accessed 12-22- 2011.

Page 155 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

L-Ornithine Hydrochloride Ornithine Hydrochloride; L- 3184-13-2 Powder Not USP unless by another 2,5-Diaminopentanoic Acid name

Losartan Losartan Potassium FDA approved tablet dosage form

Loxasperse Loxasperse Not USP unless by another name L-Triiodothyronine Sodium Triiodothyronine Sodium (L) Not USP unless by another name L-Tyrosine Tyrosine; N-Acetyl-L- 537-55-3? USP if the right stuff Tyrosine L-Valine Valine (L) Powder

Lysine Lysine, L-Lysine Acetate 57282-49-2 USP lysine lysine K3Z4F929H6 weight control

lysine aspirin lysine aspirin internal analgesic

Page 156 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Lysine Hydrochloride Lysine, L-Lysine 657-27-2 USP Hydrochloride lysine hydrochloride lysine hydrochloride JNJ23Q2COM digestive aid

lysine hydrochloride lysine hydrochloride JNJ23Q2COM weight control

Maalox and Diphenhydramine Maalox Regular Strength Diphenhydram Allen LV Jr. Oral Mucositis and Compounded Antacid ine 2.5 mg / Mouthwashes. US Pharm 2011; mL Oral 36(7)(Oncology suppl): 12-15. Solution

Maalox Regular Strength Magnesium, Aluminum, UPC 0113- Liquid USP Substance monograph? Simethicone 0851-40 Maalox, Diphenhydramine and Maalox Regular Strength Diphenhydram Lidocaine 2% Allen LV Jr. Oral Mucositis and Compounded Lidocaine Antacid ine 2.5 mg / Viscous Mouthwashes. US Pharm 2011; mL Oral 36(7)(Oncology suppl): 12-15. Solution

Maalox, Diphenhydramine and Maalox Regular Strength Diphenhydram Nystatin Oral Allen LV Jr. Oral Mucositis and Compounded Nystatin Antacid ine 2.5 mg / 100,000 Units Mouthwashes. US Pharm 2011; mL Oral / mL 36(7)(Oncology suppl): 12-15. Solution Suspension

Mafenide Acetate Mafenide Acetate 13009-99-9 USP magaldrate magaldrate antacid

Page 157 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

magnesium magnesium I38ZP9992A weight control

magnesium aluminosilicate magnesium aluminosilicate 6M2P64V0NC antacid

magnesium aluminum silicate magnesium aluminum 6M2P64V0NC acne silicate

Magnesium ascorbate Magnesium ascorbate Not USP Magnesium Bisglycinate Magnesium Bisglycinate Not USP

Magnesium Bisglycinate Magnesium Bisglycinate Powder Not USP Dihydrate 11% Dihydrate 11%

magnesium carbonate magnesium carbonate 0E53J927NA antacid

magnesium carbonate magnesium carbonate 0E53J927NA overindulgence in a hangover reliever/overindulger

Magnesium Citrate Magnesium Citrate 3344-18-1 Powder USP has magnesium citrate for oral solution monograph

magnesium citrate (oral) magnesium citrate (oral) RHO26O1T9V laxative

Page 158 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

magnesium glycinate magnesium glycinate IFN18A4Y6B antacid

Magnesium Glycinate 15% Magnesium Glycinate 15% powder Not USP

magnesium hydroxide magnesium hydroxide NBZ3QY004S antacid

magnesium hydroxide magnesium hydroxide NBZ3QY004S digestive aid antacid

magnesium hydroxide magnesium hydroxide NBZ3QY004S laxative saline laxative

magnesium oxide magnesium oxide 3A3U0GI71G antacid

magnesium oxide magnesium oxide 3A3U0GI71G weight control

magnesium salicylate magnesium salicylate 41728CY7UX internal analgesic

magnesium salicylate magnesium salicylate 41728CY7UX menstrual/diuretic analgesic

Magnesium Stearate Magnesium Stearate 557-04-0 NF, BP Magnesium Sulfate Epsom Salts 10034-99-8 USP

Page 159 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Magnesium Sulfate Magnesium Sulfate Injection, FDA approved product Powder

magnesium sulfate magnesium sulfate DE08037SAB acne

magnesium sulfate magnesium sulfate DE08037SAB laxative saline laxative

magnesium sulfate magnesium sulfate DE08037SAB menstrual/diuretic

magnesium trisilicate magnesium trisilicate C2E1CI501T antacid

magnesium trisilicate magnesium trisilicate C2E1CI501T digestive aid antacid

magnesium trisilicate magnesium trisilicate C2E1CI501T overindulgence in a hangover reliever/overindulger

Page 160 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

malt malt weight control

malt soup extract malt soup extract R3NBG8914U laxative

maltodextrin maltodextrin 7CVR7L4A2D weight control

Mandelic Acid (DC) Phenylglycolic acid; 2- USP? Hydroxy-2-phenylacetic acid

Mandelic Acid (DL) Phenylglycolic acid; 2- USP? Hydroxy-2-phenylacetic acid

Mandelic Acid AS Mandelic Acid AS 90-64-2 USP Manganese Bisglycinate Manganese Bisglycinate 13446-34-9 USP has monographs for and 10034-96- Manganese Chloride and Sulfate 5 manganese citrate manganese citrate 4Z2OA6A13N weight control

mannitol mannitol 3OWL53L36A digestive aid

mannitol mannitol 3OWL53L36A weight control

Page 161 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Mannitol and Sorbitol Mannitol and Sorbitol Mannitol 69- USP both Mannitol and Sorbitol Rowe RC, Sheskey PJ, Cook WG, Quinn ME, 65-8; Sorbitol but not the combination eds. Handbook of Pharmaceutical Excipients. 50-70-4 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Mastoid Powder Ciprofloxacin, Clotrimazole, Various Tablet, Powder USP, FDA approved products Dexamethasone, Boric Acid

MBK MBK ? m-cresol m-cresol GGO4Y809LO antifungal

meclizine hydrochloride meclizine hydrochloride HDP7W44CIO antiemetic

Medium Cream Medium Cream ? Melatonin N-[2-(5-Methoxyindol-3- 73-31-4 Powder USP yl)ethyl]acetamide; N-Acetyl- 5-methoxytryptamine

menfegol menfegol vaginal contraceptive

Menthol Natural Menthol 2216-51-5 Powder USP Menthol

Page 162 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

menthol menthol L7T10EIP3A antifungal

menthol menthol L7T10EIP3A dandruff

menthol menthol L7T10EIP3A skin protectant astringent

menthol menthol LT10EIP3A anorectal analgesic, anesthetic, antipruritic

menthol menthol LT10EIP3A anorectal counterritant

menthol menthol LT10EIP3A cough/cold antitussive

Page 163 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

menthol menthol LT10EIP3A cough/cold nasal decongestant

menthol menthol LT10EIP3A external analgesic

menthol menthol LT10EIP3A oral health care anesthetic/analgesic

menthol menthol LT10EIP3A skin protectant insect bites/stings

menthol menthol LT10EIP3A skin protectant poison ivy/oak/sumac

menthol menthol LT10EIP3A wart remover

menthol menthol LT10EIP3A relief of oral discomfort

menthol (0.1 to 1.0%) menthol (0.1 to 1.0%) LT10EIP3A external analgesic

menthol (mouthwash) menthol (mouthwash) LT10EIP3A cough/cold antihistamine

Page 164 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

menthol exceeding 1% menthol exceeding 1% L7T10EIP3A external analgesic fever blister/cold sore

menthol/peppermint oil menthol/peppermint oil cough/cold expectorant

meradimate (menthyl meradimate (menthyl J9QGD60OUZ sunscreen anthranilate) anthranilate)

meralein sodium meralein sodium oral health care

merbromin merbromin M0T18YH28D external analgesic poison ivy/oak/sumac

merbromin merbromin M0T18YH28D skin protectant poison ivy/oak/sumac

merbromin (mercurochrome) merbromin M0T18YH28D antimicrobial first aid antiseptic (mercurochrome)

Mercaptopurine Mercaptopurine 6112-76-1 Tablet, Powder USP Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 884- 885. mercufenol chloride mercufenol chloride antimicrobial first aid antiseptic (orthocholoromercuriphenol, (orthocholoromercuriphenol orthohydroxyphenyl , orthohydroxyphenyl

Page 165 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

mercuric chloride mercuric chloride 53GH7MZT1R external analgesic poison ivy/oak/sumac

mercuric chloride mercuric chloride 53GH7MZT1R skin protectant poison ivy/oak/sumac

mercuric chloride (bichloride of mercuric chloride (bichloride 53GH7MZT1R antimicrobial first aid antiseptic mercury, mercury chloride) of mercury, mercury chloride)

mercuric oxide, yellow mercuric oxide, yellow IY191986AO antimicrobial first aid antiseptic

mercuric salicylate mercuric salicylate antimicrobial first aid antiseptic

mercuric sulfide, red mercuric sulfide, red antimicrobial first aid antiseptic

mercury mercury FXS1BY2PGL antimicrobial first aid antiseptic

mercury oleate mercury oleate antimicrobial first aid antiseptic

mercury oleate mercury oleate dandruff

Page 166 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

mercury sulfide mercury sulfide antimicrobial first aid antiseptic

mercury, ammoniated mercury, ammoniated skin bleach

mercury-containing ingredient mercury-containing antimicrobial diaper rash ingredient

mercury-containing ingredient mercury-containing vaginal contractptive ingredient

metaproterenol sulfate metaproterenol sulfate GJ20H50YF0 cough/cold antihistamine

Methadone Methadone Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 893- 896.

methapyrilene fumarate methapyrilene fumarate KJ5I25TXYL cough/cold antihistamine

methapyrilene fumarate methapyrilene fumarate KJ5I25TXYL internal analgesic

Page 167 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

methapyrilene fumarate methapyrilene fumarate KJ5I25TXYL nighttime sleep aid antihistamine

methapyrilene hydrochloride methapyrilene 00S42N58OM cough/cold antihistamine hydrochloride

methapyrilene hydrochloride methapyrilene 00S42N58OM external analgesic & anesthetic hydrochloride

methapyrilene hydrochloride methapyrilene 00S42N58OM external analgesic fever blister/cold sore hydrochloride

methapyrilene hydrochloride methapyrilene 00S42N58OM external analgesic poison ivy/oak/sumac hydrochloride

methapyrilene hydrochloride methapyrilene 00S42N58OM menstrual/diuretic hydrochloride

methapyrilene hydrochloride methapyrilene 00S42N58OM nighttime sleep aid antihistamine hydrochloride

methenamine methenamine J50OIX95QV menstrual/diuretic

Page 168 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Methimazole Methimazole 60-56-0 Tablet, Powder USP, FDA approved tablet Taketomo CK, Hodding JH, Kraus DM. dosage form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 897- 898.

Methionine Methionine; L-Methionine 63-68-3 USP

methionine methionine AE28F7PNPL weight control

Methotrexate Methotrexate 59-05-2 USP methoxyphenamine methoxyphenamine 52V8BVV7FX cough/cold bronchodilator hydrochloride hydrochloride

methoxypolyoxyethyleneglycol methoxypolyoxyethylenegly vaginal contraceptive 550 laurate col 550 laurate

methyl nicotinate methyl nicotinate 7B1AVU9DJN external analgesic fever blister/cold sore

Methyl Salicylate Methyl Salicylate 119-36-8 USP methyl salicylate methyl salicylate LAV5U5022Y corn/callus remover

Page 169 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

methyl salicylate methyl salicylate LAV5U5022Y dandruff

methyl salicylate methyl salicylate LAV5U5022Y external analgesic fever blister/cold sore

methyl salicylate methyl salicylate LAV5U5022Y oral health care anesthetic/analgesic

methyl salicylate methyl salicylate LAV5U5022Y relief of oral discomfort

methyl salicylate methyl salicylate LAV5U5022Y skin protectant astringent

Methyl Sulfone MSM; Dimethyl Sulfone; 75-75-2 Powder USP CAS # is 67-71-0 Methylsulfonylmethane

methylbenzethonium chloride methylbenzethonium antimicrobial chloride

Page 170 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

methylbenzethonium chloride methylbenzethonium antimicrobial chloride

methylbenzethonium chloride methylbenzethonium corn/callus remover chloride

methylbenzethonium chloride methylbenzethonium dandruff chloride

methylcellulose methylcellulose 4GFU244C4J laxative

Page 171 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

methylcellulose methylcellulose 4GFU244C4J ophthalmic demulcents

methylcellulose methylcellulose 4GFU244C4J weight control

Methylcellulose Gel 1% Methylcellulose Gel 1% NDC 51552- Liquid ? 0702-7 Methylcellulose Oral Solution N/A N/A Liquid NF

Methylcellulose Powder Methocel E4M; Cellulose, 9004-67-5 Powder USP methyl ether Methylcobalamin Coalpha-[alpha-(5,6- 13422-55-4 powder JP, Not USP Dimethylbenzimidazolyl)]- CoBeta-methylcobamide; Mecobalamin

methylparaben methylparaben A2I8C7HI9T antifungal

Metolazone Metolazone Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 917- 918.

Page 172 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Metoprolol Metoprolol Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 918- 920.

Metronidazole Metronidazole Tablet, Powder FDA approved tablet dosage form

Page 173 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Metronidzole benzoate 2-(2-Methyl-5-nitro-1H- 13182-89-3 Powder USP, EP, BP, USP compounding Federal Register 1999 imidazol-1-yl)ethyl Benzoate monograph

Mexiletine Mexiletene Tablet, Powder FDA approved capsule dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 924- 925.

miconazole nitrate miconazole nitrate VW4H1CYW1K antifungal

Microcrystalline Cellulose Avicel Ph-105 9004-34-6 Powder USP Midazolam 8-Chloro-6-(o-fluorophenyl)- 59467-70-8 Powder USP, BP 1-methyl-4H-imidazo{1,5-a]- [1,4]benzodiazepine

mild silver protein mild silver protein ophthalmic anti-infective

Page 174 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Milk and Molasses Milk and Molasses 50:50 Liquid Loening-Baucke V. Chronic Constipation in Children. Gastroenterology 1993; 105: 1557- 1564. Thorpe DM. Management of Opiod-induced Constipation. Current Pain and Headache Reports 2001; 5: 237-240.

Milk of Sulfur Milk of Sulfur ? milk solids, dried milk solids, dried 917J3173FT antacid

Milk Thistle Silybum Marianum What is Silybin 22888-70-6 in USP? minaeral oil minaeral oil N6K5787QVP skin protectant diaper rash

Mineral Oil Mineral Oil Oil USP, FDA approved OTC product

mineral oil mineral oil T5L8T28FGP anorectal protectant

Page 175 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

mineral oil mineral oil T5L8T28FGP laxative lubricant

mineral oil mineral oil T5L8T28FGP ophthalmic emollient

mineral oil mineral oil T5L8T28FGP skin protectant

Mineral Oil and Lanolin Alcohols Mineral oil; Lanolin alcohols 8012-95-1; Both are USP, combo is not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, 8027-33-6 eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

mineral oil, light mineral oil, light T5L8T28FGP ophthalmic emollient

Minerals Minerals ? Molasses Molasses (Unsulphured) Syrup Loening-Baucke V. Chronic Constipation in Children. Gastroenterology 1993; 105: 1557- 1564. Thorpe DM. Management of Opiod-induced Constipation. Current Pain and Headache Reports 2001; 5: 237-240.

Molybdenum Glycinate Molybdenum Glycinate Nuclear

Page 176 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

mono- and di-glycerides mono- and di-glycerides weight control

Monosodium L-Aspartate Monosodium L-Aspartate Not USP unless by another name Monosodium Phosphate Monosodium Phosphate Not USP unless by another name mullein mullein 9936O846LI anorectal other

mustard oil mustard oil N4G8379626 cough/cold nasal decongestant (alltlishthiocyanate)(topical/inhal (alltlishthiocyanate)(topical/i ant) nhalant)

Mycophenolate Mofetil Mycophenolate Mofetil 128794-94-5 USP, EP

mycozyme mycozyme digestive aid

Myristic Acid 3-Mercapto-1,2-propanediol 544-63-8 USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

myrrh myrrh JC71GJ1F3L relief of oral discomfort

Page 177 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Myrrh gum tincture Myrrh gum tincture USP has monograph for Myrrh Federal Register 1999

myrrh tincture myrrh tincture JC71GJ1F3L oral health care astringent

myrrh, fluid extract of myrrh, fluid extract of JC71GJ1F3L digestive aid

Nabumetone 2-Butanone, 4-(6-methoxy-2- 4924-53-8 USP naphthalenyl)-4-(6-Methoxy- -naphthyl)-2-butanone

N-Acetyl-D-Glucosamine 2-Acetamio-2-deoxy-D- 7512-17-6 powder Not USP unless by another glucose name Nalbuphine Hydrochloride 17-Cyclobutylmethyl-7,8- 23277-43-2 Powder Not USP unless by another dihydro-14-hydroxy-17- name normorphine hydrochloride

Page 178 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Naltrexone Naltrexone Tablet, Powder FDA approved tablet dosage Chang Y, Golker L. The use of naltrexone in form the management of sever generalized pruritus in biliary atresia; report of a case. Pediatric Dermatology 2008; 25: 403-404.

naphazoline hydrochloride naphazoline hydrochloride MZ1131787D cough/cold nasal decongestant

naphazoline hydrochloride naphazoline hydrochloride MZ1131787D ophthalmic vasoconstrictor

naphazoline hydrochloride (jelly) naphazoline hydrochloride MZ1131787D cough/cold nasal decongestant (jelly)

natural estrogenic horomone natural estrogenic menstrual/diuretic horomone

Page 179 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Neohesperidine Dihydrochalcone 1-[4-][2-O-(6-Deoxy-gamma- 20702-77-6 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, L mannopyranosyl)-beta- name eds. Handbook of Pharmaceutical Excipients. D0glucopyranosy-l]oxy]-2,6- 7th ed. London, UK. Pharmaceutical Press div dihydroxyphenyl]-3-(3- Royal Pharmaceutical Society of Great Britain hydroxy-4- and Washington, DC. American Pharmacists methyxyphenyl)propan-1- Association; 2012. one

Neomycin Neomycin Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 978- 979.

neomycin ointment (combination neomycin ointment I16QD7X297 first aid antibiotic only) (combination only)

Neomycin Sulfate Neomycin Sulfate 1405-10-3 Powder USP neomycin sulfate neomycin sulfate 057Y626693 first aid antibiotic ointment

neomycin sulfate cream neomycin sulfate cream 057Y626693 first aid antibiotic

nettle nettle 0GG6WIU2KW digestive aid

niacinamide niacinamide 25X51I8RD4 menstrual/diuretic

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niacinamide niacinamide 25X51I8RD4 nightime sleep aid

niacinamide niacinamide 25X51I8RD4 weight control

nickel-pectin nickel-pectin digestive aid

Nicotinamide Nicotinamide Not USP unless by another name Nicotinic Acid Niacin, Vitamin B3 59-67-6 Not USP unless by another name Nifedipine Nifedipine 21829-25-4 USP Nimodipine 3,5-Pyridinedicarboxylic 66085-59-4 Powder USP, EP acid, 1,4-dihydro-2,6- dimethyl-4-(3-nitrophenyl)-, 2-methoxyethyl 1- methylethyl ester

nitromersol nitromersol RU6242GP15 antimicrobial first aid antiseptic

nitromersol nitromersol RU6242GP15 oral health care

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Non-Fat Dry Milk Non-Fat Dry Milk Loening-Baucke V. Chronic Constipation in Children. Gastroenterology 1993; 105: 1557- 1564. Thorpe DM. Management of Opiod-induced Constipation. Current Pain and Headache Reports 2001; 5: 237-240.

nonylphenoxypoly nonylphenoxypoly antimicrobial (ethyleneoxy)ethanol iodine (ethyleneoxy)ethanol iodine

nonylphenoxypoly nonoxynol 9 nonylphenoxypoly vaginal contraceptive nonoxynol 9

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noscapine noscapine cough/cold antitussive

noscapine hydrochloride noscapine hydrochloride cough/cold antitussive

nutmeg oil (oil of nutmet) nutmeg oil (oil of nutmet) AEE24M3MQ9 menstrual/diuretic

nux vomica extract nux vomica extract 269XH13919 digestive aid

Nystatin Nystatin 1400-61-9 Powder USP nystatin nystatin BDF1O1C72E antifungal

obtundia obtundia surgical dressing external analgesic

obtundia obtundia surgical dressing skin protectant insect stings

octinoxate octinoxate 4Y5P7MUD51 sunscreen (octylmethoxycinnamate; (octylmethoxycinnamate; ethylhexyl methoxycinnamate) ethylhexyl methoxycinnamate) octisalate (octyl salicylate; octisalate (octyl salicylate; 4X49Y0596W sunscreen ethylhexyl salicylate) ethylhexyl salicylate)

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octocrylene octocrylene 5A68WGF6WM sunscreen

octoxynol 9 octoxynol 9 7JPC6Y25QS vaginal contraceptive

Octyl Gallate Octyl 3,4,5- 1034-01-1 BP, PhEur; USP has Propyl Rowe RC, Sheskey PJ, Cook WG, Quinn ME, trihydroxybenzoate Gallate eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

octyl triazone (ethylhexyl octyl triazone (ethylhexyl sunscreen triazone) triazone)

oil of erigeron oil of erigeron menstrual/diuretic

Opium powder Opium powder antidiarrheal

Opium tincture Opium tincture antidiarrheal

organic vegetables organic vegetables weight control

Orphenadrine Citrate Orphenadrine Citrate 4682-36-4 USP

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orthophosphoric acid orthophosphoric acid E4GA8884NN digestive aid

Oseltamivir (Tamiflu) Oseltamivir Capsule, FDA approved product Powder

ox bile ox bile laxative stimulant laxative

ox bile extract ox bile extract digestive aid

Oxalic Acid Dihydrate Oxalic Acid Dihydrate 6153-56-6 Crystal USP Oxitriptan 5-Hydroxytryptophan 56-69-9 Not USP unless by another name oxybenzone (benzophenone-3) oxybenzone (benzophenone- 95OOS7VE0Y sunscreen 3)

oxymetazoline hydrochloride oxymetazoline K89MJ0S5VY cough/cold nasal decongestant (aqueous) hydrochloride (aqueous)

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oxymetazoline hydrochloride oxymetazoline K89MJ0S5VY cough/cold nasal decongestant (aqueous) hydrochloride (aqueous)

oxymetazoline hydrochloride oxymetazoline K89MJ0S5VY cough/cold nasal decongestant (jelly) hydrochloride (jelly)

oxyquinoline oxyquinoline 5UTX5635HP antifungal

oxyquinoline oxyquinoline 5UTX5635HP antimicrobial

oxyquinoline oxyquinoline 5UTX5635HP oral health care

oxyquinoline oxyquinoline 61VUG75Y3P antifungal

oxyquinoline oxyquinoline 61VUG75Y3P skin protectant astringent

Oxytetracycline Hydrochloride Oxytetracycline 148-24-3 or Powder USP Hydrochloride 2058-46-0 oxytetracycline hydrochloride oxytetracycline 4U7K4N52ZM first aid antibiotic ointment (combination only) hydrochloride (combination only)

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padimate a (5 percent or higher) padimate a (5 percent or 77FU10423X sunscreen higher)

padimate a (up to 5 percent) padimate a (up to 5 percent) 77FU10423X sunscreen

padimate o padimate o Z11006CMUZ sunscreen

pambron pambron UA8U0KJM72 menstrual/diuretic antihistamine

pancreatin pancreatin FQ3DRG0N5K digestive aid exocrine pancreatic insufficiency

pancreatin pancreatin FQ3DRG0N5K weight control

pancrelipase pancrelipase FQ3DRG0N5K digestive aid exocrine pancreatic insufficiency

panthenol panthenol WV9CM0O67Z corn/callus remover

panthenol panthenol WV9CM0O67Z external analgesic insect bite/sting

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panthenol panthenol WV9CM0O67Z external analgesic poison ivy/oak/sumac

panthenol panthenol WV9CM0O67Z skin protectant poison ivy/oak/sumac

pantothenic acid pantothenic acid 19F5HK2737 weight control

papain papain A236A06Y32 digestive aid

papain papain A236A06Y32 weight control

papaya enzymes papaya enzymes KU94FIY6JB weight control

papaya, natural papaya, natural KU94FIY6JB digestive aid

para-chloromercuriphenol para-chloromercuriphenol 3JJ4O33LAY antimicrobial diaper rash

para-chloromercuriphenol para-chloromercuriphenol 3JJ4O33LAY antimicrobial first aid antiseptic

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paraffin paraffin I9O0E3H2ZE ophthalmic emollient

paregoric paregoric antidiarrheal

parethoxycaine hydrohcloride parethoxycaine 414P5USJ7F external analgesic poison ivy/oak/sumac hydrohcloride

parethoxycaine hydrohcloride parethoxycaine 68E52E5J67 skin protectant poison ivy/oak/sumac hydrohcloride

parsley parsley 58FMD0Q0EV menstrual/diuretic

passion flower extract passion flower extract SY49TH8VUA nighttime sleep aid

Patchouli Essential Oil Patchouli Essential Oil Oil ? pectin pectin 89NA02M4RX antidiarrheal w/ sales less than $25,000

pectin pectin 89NA02M4RX external analgesic fever blister/cold sore

pectin pectin 89NA02M4RX oral health care demeculents

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pectin pectin 89NA02M4RX digestive aid

Pennyroyal Oil Pennyroyal Oil Oil Not USP unless by another name Pentoxifylline Pentoxifylline 6493-05-6 USP Pentylenetetrazole Pentylenetetrazole Not USP unless by another Federal Register 1999 name

peppermint peppermint V95R5KMY2B digestive aid

peppermint oil peppermint oil V95R5KMY2B cough/cold nasal decongestant

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peppermint oil peppermint oil V95R5KMY2B cough/cold nasal decongestant

peppermint oil peppermint oil V95R5KMY2B cough/cold antitussive

peppermint oil peppermint oil V95R5KMY2B digestive aid

peppermint oil peppermint oil V95R5KMY2B external analgesic insect bite/sting

peppermint oil peppermint oil V95R5KMY2B skin protectant astringent

peppermint oil peppermint oil V95R5KMY2B skin protectant insect bites/stings

peppermint oil (mouthwash) peppermint oil (mouthwash) V95R5KMY2B cough/cold antihistamine

peppermint oil and sage oil peppermint oil and sage oil V95R5KMY2B gingivitis/plaque

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peppermint spirit peppermint spirit V95R5KMY2B digestive aid

peppermint spirit peppermint spirit V95R5KMY2B menstrual/diuretic

pepsin pepsin digestive aid

pepsin pepsin weight control

pepsin, essence pepsin, essence menstrual/diuretic

Peruvian Balsam Peru Balsam 8007-00-9 Powder Not USP unless by another name Peruvian balsam Peruvian balsam 367E55FXGW anorectal wound healing

peruvian balsam peruvian balsam 367E55FXGW skin protectant diaper rash

peruvian balsam oil peruvian balsam oil 367E55FXGW ophthalmic

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peruvian balsam oil peruvian balsam oil 367E55FXGW skin protectant diaper rash

petrolatum petrolatum 4T6H12BN9U anorectal protectant

petrolatum petrolatum 4T6H12BN9U ophthalmic emollient

petrolatum petrolatum 4T6H12BN9U skin protectant

Petrolatum and Lanolin Alcohols Petrolatum; Lanolin alcohols 8009-03-8; See Lanolin and Petrolatum Rowe RC, Sheskey PJ, Cook WG, Quinn ME, 8027-33-6 combo? eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

petrolatum, white petrolatum, white 4T6H12BN9U ophthalmic emollient

petrolatum, white petrolatum, white 4T6H12BN9U skin protectant

phenacaine hydrochloride phenacaine hydrochloride 70C1507JU9 anorectal anesthetic

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phenacetin phenacetin ER0CTH01H9 digestive aid

phenacetin phenacetin ER0CTH01H9 internal analgesic

phenacetin phenacetin ER0CTH01H9 menstrual/diuretic

phenacetin phenacetin ER0CTH01H9 weight control

Phenazopyridine Phenazopyridine FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1097.

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Phenindamine tartrate Phenindamine tartrate Not USP - ON negative list? Federal Register 1999

phenindamine tartrate phenindamine tartrate 28725X3PV8 cough/cold antihistamine

phenindamine tartrate phenindamine tartrate 28725X3PV8 menstrual/diuretic

pheniramine maleate pheniramine maleate NYW905655B cough/cold antihistamine

pheniramine maleate pheniramine maleate NYW905655B internal analgesic

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phenobarbital phenobarbital YQE403BP4D cough/cold miscellaneous

phenol phenol 339NCG44TV acne

phenol phenol 339NCG44TV anorectal antiseptic

phenol phenol 339NCG44TV antifungal

phenol phenol 339NCG44TV antimicrobial

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phenol phenol 339NCG44TV antimicrobial

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phenol phenol 339NCG44TV antimicrobial

phenol phenol 339NCG44TV dandruff

phenol phenol 339NCG44TV external analgesic

phenol phenol 339NCG44TV oral health care anesthetic/analgesic

phenol phenol 339NCG44TV skin protectant astringent

phenol phenol 339NCG44TV skin protectant insect bites/stings

phenol phenol 339NCG44TV skin protectant poison ivy/oak/sumac

phenol phenol 339NCG44TV relief of oral discomfort

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phenol phenol 339NCG44TV relief of oral discomfort

phenolate sodium phenolate sodium 4NC0T56V35 acne

phenolate sodium phenolate sodium 4NC0T56V35 antifungal

phenolate sodium phenolate sodium 4NC0T56V35 dandruff

phenolate sodium phenolate sodium 4NC0T56V35 external analgesic

phenolate sodium phenolate sodium 4NC0T56V35 oral health care anesthetic/analgesic

phenolate sodium phenolate sodium 4NC0T56V35 relief of oral discomfort

phenolphthalein phenolphthalein 6QK969R2IF laxative stimulant laxative

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phenoxyacetic acid phenoxyacetic acid YRC253429Q corn/callus remover

phenyl salicyiate phenyl salicyiate 28A37T47QO corn/callus remover

phenyl salicylate phenyl salicylate 28A37T47QO acne

phenyl salicylate phenyl salicylate 28A37T47QO antiemetic

phenyl salicylate phenyl salicylate 28A37T47QO antifungal

phenyl salicylate phenyl salicylate 28A37T47QO menstrual/diuretic

phenyl salicylate (salo) phenyl salicylate (salo) 28A37T47QO antidiarrheal

Phenylalanine Phenylalanine; L-alpha- 63-91-2 Powder USP Amino-Beta-Phenylpropionic Acid phenylalanine phenylalanine 47E5O17Y3R weight control

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phenylephrine bitartrate phenylephrine bitartrate 27O3Q5ML57 cough/cold nasal decongestant (effervescent) (effervescent)

phenylephrine hydrochloride phenylephrine 04JA59TNSJ anorectal vasoconstrictor hydrochloride

phenylephrine hydrochloride phenylephrine 04JA59TNSJ cough/cold nasal decongestant hydrochloride

phenylephrine hydrochloride phenylephrine 04JA59TNSJ ophthalmic vasoconstrictor hydrochloride

phenylephrine hydrochloride phenylephrine 04JA59TNSJ oral health care hydrochloride

phenylephrine hydrochloride phenylephrine 04JA59TNSJ ophthalmic vasoconstrictor (0.08 to 0.2%) hydrochloride (0.08 to 0.2%)

phenylephrine hydrochloride phenylephrine 04JA59TNSJ cough/cold nasal decongestant (aqueous) hydrochloride (aqueous)

Page 201 of 1183 25 February 2014

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phenylephrine hydrochloride phenylephrine 04JA59TNSJ cough/cold nasal decongestant (aqueous) hydrochloride (aqueous)

phenylephrine hydrochloride phenylephrine 04JA59TNSJ cough/cold nasal decongestant (jelly) hydrochloride (jelly)

phenylmercuric acetate phenylmercuric acetate OSX88361UX vaginal contraceptive

Phenylmercuric Borate [Orthoborato(3-)-O]- 102-98-7 USP has monographs for Rowe RC, Sheskey PJ, Cook WG, Quinn ME, phenylmercurate(2- Phenylmercuric acetate and eds. Handbook of Pharmaceutical Excipients. )dihydrogen nitrate 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

phenylmercuric nitate phenylmercuric nitate CG8692ZN14 antimicrobial first aid antiseptic

phenylmercuric nitrate phenylmercuric nitrate CG8692ZN14 vaginal contraceptive

Page 202 of 1183 25 February 2014

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phenylpropanolamine bitartrate phenylpropanolamine B48FTC099P cough/cold nasal decongestant bitartrate

phenylpropanolamine phenylpropanolamine 8D5I63UE1Q oral health care hydrochloride hydrochloride

phenylpropanolamine phenylpropanolamine 8D5I63UE1Q weight control hydrochloride hydrochloride

phenylpropanolamine phenylpropanolamine 8D5I63UE1Q cough/cold nasal decongestant hydrochloride (oral) hydrochloride (oral)

phenylpropanolamine phenylpropanolamine 8D5I63UE1Q cough/cold nasal decongestant hydrochloride (topical) hydrochloride (topical)

phenylpropanolamine maleate phenylpropanolamine cough/cold nasal decongestant maleate

Phenyltoloxamine Phenyltoloxamine Citrate 1176-08-5 USP Federal Register 1999

Page 203 of 1183 25 February 2014

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phenyltoloxamine citrate phenyltoloxamine citrate 8UE48MJH8M internal analgesic

phenyltoloxamine dihydrogen phenyltoloxamine 8UE48MJH8M cough/cold antihistamine citrate dihydrogen citrate

phenyltoloxamine dihydrogen phenyltoloxamine 8UE48MJH8M external analgesic poison ivy/oak/sumac citrate dihydrogen citrate

phenyltoloxamine dihydrogen phenyltoloxamine 8UE48MJH8M internal analgesic citrate dihydrogen citrate

phenyltoloxamine dihydrogen phenyltoloxamine 8UE48MJH8M menstrual/diuretic antihistamine citrate dihydrogen citrate

phenyltoloxamine dihydrogen phenyltoloxamine 8UE48MJH8M nighttime sleep aid antihistamine citrate dihydrogen citrate

phenyltoloxamine dihydrogen phenyltoloxamine 8UE48MJH8M skin protectant poison ivy/oak/sumac citrate dihydrogen citrate

phenyltoloxamine hydrochloride phenyltoloxamine cough/cold antihistamine hydrochloride

phosphate fluoride phosphate fluoride acidulated anticaries

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phosphate fluoride phosphate fluoride acidulated anticaries

Phospholipids See table Many USP, NF Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

phosphorated carbohydrate phosphorated carbohydrate antiemetic

phosphoric acid phosphoric acid E4GA8884NN anticaries

phosphorus phosphorus 27YLU75U4W weight control

phytolacca phytolacca 11E6VI8VEG weight control

Phytonadione Phytonadione Methylcellulos Sorbitol 70% Solution Taketomo CK, Hodding JH, Kraus DM. e 1% Pediatric Dosage Handbook, 17th ed. Suspension Hudson, Ohio, Lexi-Comp, Inc. 2010: 1109- 1110.

picrotoxin picrotoxin ZLT174DL7U pediculicide

Page 205 of 1183 25 February 2014

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Pilocarpine Nitrate Pilocarpine Nitrate 148-72-1 Powder USP Cystic Fibrosis Sweat Testing for Diagnosis

Pilocarpine Nitrate Pilocarpine Nitrate

Pimobendan Pimobendan 74150-27-9 Powder EP pine tar pine tar dandruff

pine tar preparations (extract pine tar preparations cough/cold expectorant white pine compound, pine tar, (extract white pine syrup of compound, pine tar, syrup of pineapple enzymes pineapple enzymes weight control

piperazine citrate piperazine citrate 63KP7FXF2I anthelmintic

piperocaine hydrochloride piperocaine hydrochloride Q2RH0XR1MB ophthalmic anesthetic

Page 206 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

piperonyl butoxide (combination) piperonyl butoxide LWK91TU9AH pediculicide (combination)

pipsissewa pipsissewa menstrual/diuretic

Piracetam Pyrrolidone Acetamide; 2-(2- 7491-74-9 Powder EP Oxopyrrolidin-1- yl)acetamide Piracetam dihydrogen citrate Piracetam dihydrogen 7491-74-9? Federal Register 1999 citrate

Piroxicam Piroxicam 36322-90-4 USP piscidia erythrina piscidia erythrina 58JV0P12FY menstrual/diuretic botanical herb

plantago ovata husks plantago ovata husks laxative bulk laxative

plantago seed plantago seed 9C60Y73166 laxative bulk laxative

Page 207 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

plantago seed plantago seed 9C60Y73166 weight control

plantago seed husks [see psyllium plantago seed husks [see 9C60Y73166 laxative seed husks] psyllium seed husks]

plantago seed, blond [see plantago seed, blond [see 9C60Y73166 laxative plantago seed] plantago seed]

Podophyllum Resin Podophyllum Resin USP, BP podophyllum resin (podophyllin) podophyllum resin laxative stimulant laxative (podophyllin)

Polidocanol (Laureth-9) Polidocanol (Laureth-9) 9002-92-0 USP? poloxamer poloxamer laxative stool softener

poloxamer 188 poloxamer 188 LQA7B6G8JG antimicrobial

poloxamer 407 poloxamer 407 TUF2IVW3M2 relief of oral discomfort

poloxamer-iodine complex poloxamer-iodine complex antimicrobial

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

poloxamer-iodine complex poloxamer-iodine complex antimicrobial

Poly(DL-Lactic Acid) Poly[oxy(1-methyl-2-oxo-1,2- 26023-30-3 or There is a USP monograph for Rowe RC, Sheskey PJ, Cook WG, Quinn ME, ethanediyl)] 26680-10-4 Lactic Acid [50-21-5] eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Poly(methyl vinyl ether/maleic Various 9011-16-9; Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, anhydride) 25153-40-6; eds. Handbook of Pharmaceutical Excipients. 25087-06-3; 7th ed. London, UK. Pharmaceutical Press div 64-17-5; Royal Pharmaceutical Society of Great Britain 25087-06-3; and Washington, DC. American Pharmacists 25119-68-0; Association; 2012. 64-17-5 200- 751-6; 62386- 95-2 polycarbophil polycarbophil antidiarrheal w/ sales less than 25,000

polycarbophil polycarbophil laxative

polydimethylsiloxane and polydimethylsiloxane and gingivitis/plaque poloxamer poloxamer

Polyethyle Glycol 3350 Polyethyle Glycol 3350 25322-68-3 USP Polyethylene Glycol 1450 Polyethylene Glycol 1450

Polyethylene Glycol 300 Polyethylene Glycol 300 25322-68-3 USP

polyethylene glycol 300 polyethylene glycol 300 5655G9Y8AQ ophthalmic demulcents

polyethylene glycol 400 polyethylene glycol 400 B697894SGQ ophthalmic demulcents

Page 210 of 1183 25 February 2014

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polyethylene glycol 6000 polyethylene glycol 6000 30IQX730WE ophthalmic demulcents

Polyethylene Glycol 8000 Polyethylene Glycol 8000 25322-68-3 USP

polymyxin b sulfate (combination polymyxin b sulfate 19371312D4 first aid antibiotic ointment only) (combination only)

polyols, liquid polyols, liquid ophthalmic demulcents

polyoxeythylene laurate polyoxeythylene laurate skin protectant astringent

Polyoxyethylene (20) Sorbitan Polyoxyl 20 Sterayl Ether? 9005-00-9? USP? Monolaurate Polyoxyl 40 Stearate PEG-40 Stearate 9004-9903 usp Polysorbate 20 Polysorbate 20 9005-64-5 NF polysorbate 80 polysorbate 80 6OZP39ZG8H ophthalmic demulcents

polyvinyl alcohol polyvinyl alcohol 532B59J990 ophthalmic demulcents

Potash Lye Potassium Hydroxide 16893-85-9 USP has Sulfurated Potash

Potassium Acetate Potassium Acetate 127-08-2 USP

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potassium acetate potassium acetate M911911U02 menstrual/diuretic

potassium bicarbonate potassium bicarbonate HM5Z15LEBN antacid

potassium bicarbonate potassium bicarbonate HM5Z15LEBN digestive aid

Potassium Bitartrate Cream of Tarter 868-14-4 Powder USP, FCC Potassium Bromide Potassium Bromide USP? potassium bromide potassium bromide OSD78555ZM nighttime sleep aid bromide

potassium carbonate potassium carbonate BQN1B9B9HA antacid

potassium carbonate potassium carbonate BQN1B9B9HA antacid antidiarrheal w/ sales less than $25,000

potassium carbonate potassium carbonate BQN1B9B9HA digestive aid

potassium chlorate potassium chlorate H35KS68EE7 oral health care

Page 212 of 1183 25 February 2014

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Potassium Chloride Potassium Chloride 7447-40-7 Powder, USP, FDA approved product Management of metabolic acidosis; antacid; Injection alkalinization of urine and stabilization of acid base status.

Potassium Chloride Potassium Chloride 7447-40-7 Powder USP

potassium citrate potassium citrate EE90ONI6FF weight control

potassium ferrocyanide potassium ferrocyanide GTP1P30292 skin protectant astringent

potassium guaiacolsulfonate potassium guaiacolsulfonate TTK33Z47F1 cough/cold expectorant

Potassium Hydroxide, 10% (w/v) Potassium Hydroxide, 10% 1310-58-3 NF has monograph for Solution (w/v) Solution Potassium Hydroxide CAS 1310- 58-3 potassium iodide potassium iodide 1C4QK22F9J oral health care expectorant

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Potassium Iodide "Diluted" Potassium Iodide "Diluted" Oral Solution USP, FDA approved oral solution Home Preparation Procedure for Emergency Solution Solutoin product too concentrated for Administration of Potassium Iodide Tablets pediatric use measuring to Infants and Small Children. http://www.fda.gov/downloads/Drugs/Emer gencyPreparedness/BioterrorismandDrugPre paredness/ucm072757.pdf Accessed 6-11- 2013.

potassium nitrate potassium nitrate RU45X2JN0Z menstrual/diuretic

Potassium Phosphate Potassium Phosphate Powder, FDA approved injection dosage Injection form

Potassium Phosphate Dibasic Potassium Phosphate 7758-11-4 USP Dibasic

Potassium Phosphate Monobasic Potassium Phosphate 7778-77-0 USP Monobasic

potassium salicylate potassium salicylate K91YT16P5M internal analgesic

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povidone povidone FZ989GH94E ophthalmic demulcents

Povidone (K-30) Povidone (K-30) 9003-39-8 Powder USP povidone-iodine povidone-iodine 85H0HZU99M acne

povidone-iodine povidone-iodine 85H0HZU99M dandruff

povidone-iodine povidone-iodine 85H0HZU99M oral health care

povidone-iodine povidone-iodine 85H0HZU99M antifungal

povidone-iodine povidone-iodine 85H0HZU99M antimicrobial

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

povidone-iodine povidone-iodine 85H0HZU99M antimicrobial

povidone-vinylacetate povidone-vinylacetate external analgesic poison ivy/oak/sumac copolymers copolymers

povidone-vinylacetate povidone-vinylacetate skin protectant poison ivy/oak/sumac copolymers copolymers

Pracasil-Plus Pracasil-Plus Not USP pramoxine hydrochloride pramoxine hydrochloride 88AYB867L5 anorectal local anesthetic

pramoxine hydrochloride pramoxine hydrochloride 88AYB867L5 external analgesic

pramoxine hydrochloride pramoxine hydrochloride 88AYB867L5 skin protectant diaper rash

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pramoxine hydrochloride (in pramoxine hydrochloride (in 88AYB867L5 anorectal combination) combination)

precipitated sulfur precipitated sulfur 70FD1KFU70 anorectal keratolytic

Pregnenolone Micornized Pregnenolone Micornized 145-13-1 Powder Not USP unless by another name Prilocaine Hydrochloride Prilocaine Hydrochloride 1786-81-8 USP

Primaquine Primaquine base FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1153- 1154.

prolase prolase digestive aid

Proline Proline; L-Proline 147-85-3 USP Propionic Acid 2-(2-Fluorobiphenyl-4- 79-09-4 USP yl)propionic Acid propionic acid propionic acid JHU490RVYR antifungal

Propylene Glycol Propylene Glycol Liquid USP propylene glycol propylene glycol 6DC9Q167V3 ophthalmic demulcents

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

propylene glycol propylene glycol 6DC9Q167V3 pediculicide

propylhexedrine propylhexedrine LQU92IU8LL cough/cold nasal decongestant

propylparaben propylparaben Z8IX2SC1OH antifungal

Propylthiouracil Propythiouracil Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1178- 1180.

protease protease digestive aid

protein hydrolysate protein hydrolysate skin protectant diaper rash

Protirelin Thyrotropin-releasing 24305-27-9 Not USP hormone prune concentrate dehydrate prune concentrate S8O01I9YLZ laxative stimulant laxative dehydrate

prune powder prune powder S8O01I9YLZ laxative stimulant laxative

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

pseudoephedrine hydrochloride pseudoephedrine 6V9V2RYJ8N cough/cold bronchodilator hydrochloride

pseudoephedrine hydrochloride pseudoephedrine 6V9V2RYJ8N cough/cold nasal decongestant hydrochloride

pseudoephedrine sulfate pseudoephedrine sulfate Y9DL7QPE6B cough/cold bronchodilator

pseudoephedrine sulfate pseudoephedrine sulfate Y9DL7QPE6B cough/cold nasal decongestant

pseudoephedrine sulfate (oral) pseudoephedrine sulfate Y9DL7QPE6B cough/cold nasal decongestant (oral)

psyllium (hemicellulose) [see psyllium (hemicellulose) [see 9C60Y73166 laxative plantago seed] plantago seed]

psyllium hydrophillic mucilloid psyllium hydrophillic laxative mucilloid

psyllium seed psyllium seed 9C60Y73166 laxative

psyllium seed (blond) psyllium seed (blond) laxative

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

psyllium seed husks psyllium seed husks laxative

psylllium (hemicellulose) psylllium (hemicellulose) laxative bulk laxative

p-t-butyl-m-cresol p-t-butyl-m-cresol 0462U14DUI skin protectant astringent

pyrantel pamoate pyrantel pamoate 81BK194Z5M anthelmintic

Pyrazinamide Pyrazinamide Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1188- 1189.

pyrethrum extract (combination) pyrethrum extract ZUM06L90GV pediculicide aerosol (combination)

pyrethrum extract (combination) pyrethrum extract ZUM06L90GV pediculicide non-aerosol (combination)

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Pyridoxal-5-Phosphate, Codecarboxylase; 3-Hydroxy- 41468-25-1 powder Not USP unless by another Monohydrate 5-hydroxymethyl-2- name methylpyridine-4- carboxaldehyde 5'- Phosphate; Pyridoxal Phosphate

Pyridoxine Pyridoxine Hydrochloride Pyridoxine Injection, FDA approved injection and OTC Taketomo CK, Hodding JH, Kraus DM. Hydrochloride Powder dosage forms Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1190- 1191.

pyridoxine hydrochloride pyridoxine hydrochloride 68Y4CF58BV menstrual/diuretic vitamine

pyridoxine hydrochloride pyridoxine hydrochloride 68Y4CF58BV skin protectant fever blister/cold sore

pyridoxine hydrochloride pyridoxine hydrochloride 68Y4CF58BV weight control (vitamine B6) (vitamine B6)

Pyridoxyl-5-Phosphate Pyridoxyl-5-Phosphate Not USP unless by another name pyrilamine maleate pyrilamine maleate R35D29L3ZA acne

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

pyrilamine maleate pyrilamine maleate R35D29L3ZA cough/cold antihistamine

pyrilamine maleate pyrilamine maleate R35D29L3ZA external analgesic insect bite/sting

pyrilamine maleate pyrilamine maleate R35D29L3ZA external analgesic poison ivy/oak/sumac

pyrilamine maleate pyrilamine maleate R35D29L3ZA internal analgesic

pyrilamine maleate pyrilamine maleate R35D29L3ZA menstrual/diuretic antihistamine

pyrilamine maleate pyrilamine maleate R35D29L3ZA nighttime sleep aid antihistamine

pyrilamine maleate pyrilamine maleate R35D29L3ZA oral health care anesthetic/analgesic

pyrilamine maleate pyrilamine maleate R35D29L3ZA skin protectant insect bites/stings

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pyrilamine maleate pyrilamine maleate R35D29L3ZA skin protectant poison ivy/oak/sumac

Pyrimethamine Pyrimethamine FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010; 1191- 1192.

pyrithione zinc pyrithione zinc R953O2RHZ5 dandruff (wash-off)

pyrithione zinc pyrithione zinc R953O2RHZ6 dandruff (leave-on)

pyrithione zinc pyrithione zinc R953O2RHZ7 dandruff seborrheic dermatitis (wash-off)

pyrithione zinc pyrithione zinc R953O2RHZ8 dandruff seborrheic dermatitis (leave-on)

Pyrrolidone 2-Pyrrolidinone 616-45-5 BP, PhEUR; USP has Rowe RC, Sheskey PJ, Cook WG, Quinn ME, methylpyrrolidone eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Pyruvic Aldehyde 40% Aqueous Pyruvaldehyde 78-98-8 Solution Pyruvic Acid is USP 127-17-3 Solution Quinacrine Hydrochloride Quinacrine Hydrochloride 6151-30-0 USP

quinine quinine A7V27PHC7A antimalarial

quinine quinine A7V27PHC7A internal analgesic

racemethionine racemethionine 73JWT2K6T3 skin protectant diaper rash

racephedrine hydrochloride racephedrine hydrochloride 43SK4LAO7D cough/cold bronchodilator

racephedrine hydrochloride racephedrine hydrochloride 43SK4LAO7D cough/cold nasal decongestant (oral/topical) (oral/topical)

racepinephrine hydrochloride racepinephrine 43SK4LAO7D cough/cold bronchodilator hydrochloride

Page 224 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Raffinose BD-Fructofuranosyl-O- 512-69-6 Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, gamma-D-galactopyranosyl- eds. Handbook of Pharmaceutical Excipients. (1-6)-gamma-D- 7th ed. London, UK. Pharmaceutical Press div glucopyranoside, anhydrous Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Ranitidine Hydrochloride Ranitidine Hydrochloride 66357-59-3 USP

red petrolatum red petrolatum sunscreen

reosote reosote relief of oral discomfort

resorcinol resorcinol YUL4LO94HK anorectal antiseptic

resorcinol resorcinol YUL4LO94HK anorectal keratolytic

resorcinol resorcinol YUL4LO94HK antifungal

resorcinol resorcinol YUL4LO94HK antimicrobial

Page 225 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

resorcinol resorcinol YUL4LO94HK dandruff

resorcinol resorcinol YUL4LO94HK external analgesic

resorcinol resorcinol YUL4LO94HK skin protectant diaper rash

resorcinol (as single ingredient resorcinol (as single YUL4LO94HK acne only) ingredient only)

resorcinol (when combined with resorcinol (when combined YUL4LO94HK acne sulfur) with sulfur)

resorcinol monoacetate (as single resorcinol monoacetate (as YUL4LO94HK acne ingreidnet only) single ingreidnet only)

resorcinol monoacetate (in resorcinol monoacetate (in YUL4LO94HK acne combination with sulfur) combination with sulfur)

Resveratrol Resveratrol Not USP Retinoic Acid-All Trans Retinoic Acid-All Trans Not USP unless by another name rhubarb fluid extract rhubarb fluid extract G280W4MW6E digestive aid

Page 226 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

rhubarb fluidextract rhubarb fluidextract G280W4MW6E antidiarrheal w/ sales less than $25,000

rhubarb, Chinese rhubarb, Chinese laxative stimulant laxative

riboflavin riboflavin TLM2976OFR menstrual/diuretic

riboflavin riboflavin TLM2976OFR weight control

rice polishings rice polishings weight control

Rifabutin Rifabutin Rifabutin Capsule, FDA approved capsule dosage Taketomo CK, Hodding JH, Kraus DM. Powder form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1213- 1215.

Rifampin Rifampin Rifampin Capsule, FDA approved capsule dosage Taketomo CK, Hodding JH, Kraus DM. Powder form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1215- 1216.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

riFAXimin Rifaximin Rifaximin Tablet, Powder FDA approved tablet dosage Rifaximin (Xifaxan). [Package insert]. Salix form Pharmaceuticals, Inc., Morrisville, NC. November 2010.

romohydrate romohydrate aluminum b antiperspirant

sabadilla, alkaloids sabadilla, alkaloids 6NAF1689IO pediculicide

saccharin saccharin FST467XS7D weight control

Saccharin Sodium Saccharin Sodium 6155-57-3 USP sage oil sage oil U27K0H1H2O skin protectant astringent

salicyl alcohol salicyl alcohol FA1N0842KB oral health care

salicylamide salicylamide EM8BM710ZC internal analgesic

salicylamide salicylamide EM8BM710ZC menstrual/diuretic

Page 228 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

salicylamide salicylamide EM8BM710ZC nighttime sleep aid

salicylamide salicylamide EM8BM710ZC external analgesic & anesthetic

salicylamide salicylamide EM8BM710ZC external analgesic fever blister/cold sore

salicylamide salicylamide EM8BM710ZC external analgesic poison ivy/oak/sumac

salicylic acid salicylic acid O414PZ4LPZ acne

salicylic acid salicylic acid O414PZ4LPZ corn/callus remover collodoin-like vehicle

salicylic acid salicylic acid O414PZ4LPZ corn/callus remover plaster vehicle

salicylic acid salicylic acid O414PZ4LPZ dandruff

salicylic acid salicylic acid O414PZ4LPZ dandruff psoriasis

Page 229 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

salicylic acid salicylic acid O414PZ4LPZ dandruff seborrheic dermatitis

salicylic acid salicylic acid O414PZ4LPZ wart remover collodoin-like vehicle

salicylic acid salicylic acid O414PZ4LPZ wart remover karaya gum, glycol plaster vehicle

salicylic acid salicylic acid O414PZ4LPZ wart remover plaster vehicle

salicylic acid salicylic acid O414PZ4LPZ antifungal

salicylic acid salicylic acid O414PZ4LPZ external analgesic poison ivy/oak/sumac

salicylic acid salicylic acid O414PZ4LPZ skin protectant poison ivy/oak/sumac

salicylic acid (over 2 up to 5%) salicylic acid (over 2 up to O414PZ4LPZ acne 5%)

salsalate salsalate V9MO595C9I internal analgesic

Page 230 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

sanguinaria extract sanguinaria extract N9288CD508 gingivitis/plaque

Saponite Saponite 1319-41-1 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, name eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

saw palmetto saw palmetto J7WWH9M8QS menstrual/diuretic

scopalamine hydrobromide scopalamine hydrobromide 451IFR0GXB nighttime sleep aid scopolamine compound

scopolamine aminoxide scopolamine aminoxide nighttime sleep aid scopolamine compound hydrobromide hydrobromide

scopolamine hydrobromide scopolamine hydrobromide 451IFR0GXB antidiarrheal

sea mineral sea mineral weight control

Secretin, human 99% Secretin, human 99% Not USP unless by another name

Page 231 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Selenium Selegiline Hydrochloride 14611-52-0 Injection, USP is for Selenium Sulfide CAS Taketomo CK, Hodding JH, Kraus DM. Powder 7488-56-4 Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010; 1367.

selenium sulfide selenium sulfide Z69D9E381Q dandruff

selenium sulfide selenium sulfide Z69D9E381Q dandruff seborrheic dermatitis

selenium sulfide, micronized selenium sulfide, micronized Z69D9E381Q dandruff

Selenomethionine (l) Butanoic acid, 2-amino-4- 1464-42-2 USP (methylseleno)-, (S)-' (S)-2- Amino-4- (methylselenyl)butyric acid

senecio aureus senecio aureus 5WS1632J8W menstrual/diuretic botanical/vegetable herb

senna senna AK7JF626KX digestive aid

Page 232 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

senna fluidextract senna fluidextract AK7JF626KX laxative

senna pod concentrate senna pod concentrate S8SJ19N2NX laxative

senna syrup senna syrup laxative

sennosides a and b sennosides a and b laxative

Serine Serine; L-Serine 56-45-1 USP Serotonin Hydrochloride Serotonin Hydrochloride ?

Sesame Oil Sesame Oil NF sesame seed sesame seed 7Y1255HVXR weight control

shark liver oil shark liver oil 4B24275HEU anorectal wound healing

shark liver oil shark liver oil 4B24275HEU antimicrobial

shark liver oil shark liver oil 4B24275HEU skin protectant insect bites/stings w/ sales less than $2

Page 233 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

shark liver oil shark liver oil 4B24275HEU skin protectant poison ivy/oak/sumac w/ sales less than $25,000

shark liver oil shark liver oil 4B24275HEU skin protectant w/ sales less than $25,000

shark liver oil (combination only) shark liver oil (combination 4B24275HEU anorectal protectant only)

Shea Butter, Organic Shea Butter, Organic ? Short Chain Fatty Acid Sodium Acetate Trihydrate Sodium Sodium Sodium Chloride Granular USP- Harig JM, Soergel KH, Komorowski RA, Wood Propionate Butyrate NF CM. Treatment of Diversion Colitis with Short FCC chain Fatty Acid Irrigation. N Engl J Med 1989 Jan. 5; 320(1): 23-28.

Sildenafil Citrate Sildenafil Citrate 171599-33-0 Tablet, Powder USP Carroll WD, Dhillon R. Sildenafil as a treatment for Pulmonary Hypertension. Arch Dis Chil 2003 Sept; 88(9): 827-828.

silver nitrate silver nitrate 95IT3W8JZE skin protectant astringent

Page 234 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Silver protein mild Silver, Colloidal; Silver 9015-51-4 Powder Silver sulfadiazine in USP Federal Register 1999 Nucleate; Mild Protargin

Silver, Colloidal Silver, Colloidal Not in USP; nuclear? simethicone simethicone TYU5GP6XGE antiflatulent

simethicone simethicone TYU5GP6XGE digestive aid antiflatulent

simethicone simethicone TYU5GP6XGE external analgesic

Page 235 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

simethicone simethicone TYU5GP6XGE skin protectant poison ivy/oak/sumac

Simple Syrup Syrup USP Simplgel 30 Polyacrylamide/C13-14 USP Chapter on Polyacrylamides Isoparaffin/Laureth-7 Sirolimus Sirolimus Oral Solution 1 mg FDA approved capsules and McNamara EK, Curtis AR, Fleischer AB. Case / mL liquid dosage forms Report: Successful treatment of angiofibromata of tuberous sclerosis complex with rapamycin. J of Dermat Treat 2010; Early Online, 1-3.

skin protectant skin protectant aromatics astringent

sodium sodium weight control

sodium 3, 4-dimethylphenyl- sodium 3, 4-dimethylphenyl- 25K35WQ32Q sunscreen glyoxylate glyoxylate

sodium acetylsalicylate (in sodium acetylsalicylate (in overindulgence in a hangover reliever solution) solution)

sodium aluminum chlorohydroxy sodium aluminum antiperspirant lactate chlorohydroxy lactate

Page 236 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Sodium Aspartate Sodium Aspartate USP Sorta

Sodium Benzoate Sodium Benzoate USP-NF 532-32-1 Powder NF Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1268- 1269.

sodium benzoate sodium benzoate OJ245FE5EU menstrual/diuretic

Sodium Bicarbonate Sodium Bicarbonate 144-55-8 Powder USP, FDA approved product, Taketomo CK, Hodding JH, Kraus DM. Meets ACS Reagent Chemical Pediatric Dosage Handbook, 17th ed. Requirements for Lab Research Hudson, Ohio, Lexi-Comp, Inc. 2010.

sodium bicarbonate sodium bicarbonate 8MDF5V39QO analgesic

sodium bicarbonate sodium bicarbonate 8MDF5V39QO antacid

sodium bicarbonate sodium bicarbonate 8MDF5V39QO anticaries

Page 237 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

sodium bicarbonate sodium bicarbonate 8MDF5V39QO digestive aid antacid

sodium bicarbonate sodium bicarbonate 8MDF5V39QO gingivitis/plaque

sodium bicarbonate sodium bicarbonate 8MDF5V39QO oral health care wound cleansing

sodium bicarbonate sodium bicarbonate 8MDF5V39QO skin protectant

sodium bicarbonate sodium bicarbonate 8MDF5V39QO weight control

Sodium Biphosphate Sodium Biphosphate Not in USP Sodium Bisulfate Sodium Bisulfate Powder ACS Reagent, Not in USP sodium borate sodium borate 91MBZ8H3QO acne

sodium borate sodium borate 91MBZ8H3QO antifungal

sodium borate sodium borate 91MBZ8H3QO dandruff

Page 238 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

sodium borate sodium borate 91MBZ8H3QO external analgesic insect bite/sting

sodium borate sodium borate 91MBZ8H3QO oral health care

sodium borate sodium borate 91MBZ8H3QO skin protectant astringent

sodium borate sodium borate 91MBZ8H3QO skin protectant insect bites/stings

sodium borate monohydrate sodium borate monohydrate 91MBZ8H3QO oral health care

Sodium Bromide Sodium Bromide 7647-15-6 Granules USP, Reagent, ACS sodium bromide sodium bromide LC1V549NOM daytime sedative

sodium bromide sodium bromide LC1V549NOM nighttime sleep aid bromide

Page 239 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Sodium Butyrate Sodum Butyrate 156-54-7 usp Federal Register 1999

Sodium Caprylate Octanoic Acid Sodium Salt; Powder NF, Food Grade Sodium Octanoate; Caprylic Acid Sodium Salt

sodium caprylate sodium caprylate 9XTM81VK2B antifungal

sodium caprylate sodium caprylate 9XTM81VK2B oral health care

sodium carbonate sodium carbonate 45P3261C7T antacid

sodium carbonate sodium carbonate 45P3261C7T anticaries

Page 240 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

sodium carboxymethylcellulose sodium antidiarrheal carboxymethylcellulose

sodium carboxymethylcellulose sodium laxative bulk laxative carboxymethylcellulose

sodium caseinate sodium caseinate 7473P66J9E weight control

Sodium Chloride Sodium Chloride 7647-14-5 Powder, USP, substance and product Taketomo CK, Hodding JH, Kraus DM. Crystal, Tablet monograph, FDA Approved OTC Pediatric Dosage Handbook, 17th ed. Active tablet product Hudson, Ohio, Lexi-Comp, Inc. 2010: 1270- 1273.

Sodium Chloride Sodium Chloride 7647-14-5 Powder, USP, substance and product Taketomo CK, Hodding JH, Kraus DM. Crystal monograph, FDA approved Pediatric Dosage Handbook, 17th ed. product Hudson, Ohio, Lexi-Comp, Inc. 2010: 1270- 1273.

sodium chloride sodium chloride 451W47IQ8X digestive aid

sodium chloride sodium chloride 451W47IQ8X ophthalmic hypertonic agent

Page 241 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

sodium chloride (salt) sodium chloride (salt) 451W47IQ8X weight control

sodium citrate sodium citrate 1Q73Q2JULR cough/cold expectorant

sodium citrate sodium citrate 1Q73Q2JULR digestive aid antacid

sodium citrate sodium citrate 1Q73Q2JULR relief of oral discomfort

sodium citrate in solution sodium citrate in solution 1Q73Q2JULR overindulgence in a hangover reliever/overindulgence

Sodium Cyclamate Sodium N- 139-05-9 USP, BP, PhEur Rowe RC, Sheskey PJ, Cook WG, Quinn ME, cyclohexylsulfamate eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

sodium diacetate sodium diacetate 26WJH3CS0B skin protectant astringent

sodium dichromate sodium dichromate oral health care

Page 242 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Sodium Dihydrogen Phosphate Sodium Dihydrogen Not USP unless by another Phosphate name sodium dihydrogen phosphate sodium dihydrogen 3980JIH2SW anticaries phosphate

sodium dihydrogen phosphate sodium dihydrogen anticaries monohydrate phosphate monohydrate

sodium fluoride sodium fluoride 8ZYQ1474W7 relief of oral discomfort

sodium fluoride (aqueous) sodium fluoride (aqueous) 8ZYQ1474W7 anticaries

sodium fluoride (aqueous) sodium fluoride (aqueous) 8ZYQ1474W7 anticaries (acidulated phosphate fluoride (acidulated phosphate with .01% fl) fluoride with .01% fl)

sodium fluoride (aqueous) sodium fluoride (aqueous) 8ZYQ1474W7 anticaries (acidulated phosphate fluoride (acidulated phosphate with 0.2% fl) fluoride with 0.2% fl)

sodium fluoride gel or paste sodium fluoride gel or paste 8ZYQ1474W7 anticaries dentrifrices

Page 243 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

sodium fluoride powder sodium fluoride powder 8ZYQ1474W7 anticaries dentrifrices

Sodium Hyaluronate Sodium hyaluronate 9067-32-7 BP, PhEur Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Sodium Hydroxide 1N Sodium Hydroxide 1N 7732-18-5 Liquid Not USP unless by another Concentrate name

sodium monofluoro phosphate sodium monofluoro C810JCZ56Q anticaries phosphate

sodium monofluoro phosphate sodium monofluoro C810JCZ56Q relief of oral discomfort phosphate

sodium monofluoro phosphate sodium monofluoro C810JCZ56Q anticaries dentrifrices (gel or paste) phosphate (gel or paste)

sodium monofluoro phosphate sodium monofluoro C810JCZ56Q anticaries (rinse) phosphate (rinse)

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Sodium Nitrate Sodium Nitrate 7631-98-4 Powder Reagent Plus >= 99.0% (Sodium Nitrite in USP)

sodium nitrate sodium nitrate 8M4L3H2ZVZ menstrual/diuretic

Sodium Octanoate Sodium Octanoate Not USP unless by another name sodium oleate sodium oleate 399SL044HN laxative stimulant laxative

sodium para-amino benzoate sodium para-amino 75UI7QUZ5J internal analgesic benzoate

sodium perborate sodium perborate Y52BK1W96C oral health care

sodium perborate monohydrate sodium perborate Y9UKD0XE6F oral health care wound cleansing monohydrate

Page 245 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Sodium Phosphate Sodium Phosphate Dibasic Sodium Solution FDA approved product Anhydrous, USP Phosphate Monobasic Anhydrous, USP

sodium phosphate sodium phosphate SE337SVY37 anticaries

Sodium Phosphate Dibasic Dried NDC 51552--0447-6 Powder Not USP unless by another Anhydrous name, FDA approved injection

Sodium Phosphate Monobasic Sodium Phosphate NDC 51552- Powder Not USP unless by another Anhydrous Monobasic Anhydrous 0815-6 name, FDA approved injection

sodium phosphate, dibasic sodium phosphate, dibasic SE337SVY37 laxative saline laxative

sodium phosphate, monobasic sodium phosphate, SE337SVY37 laxative saline laxative monobasic

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

sodium potassium tartrate sodium potassium tartrate QH257BPV3J antacid

sodium propionate sodium propionate DK6Y9P42IN antifungal

sodium propionate sodium propionate DK6Y9P42IN antimicrobial

sodium salicylate sodium salicylate WIQ1H85SYP dandruff

sodium salicylate sodium salicylate WIQ1H85SYP digestive aid

sodium salicylate sodium salicylate WIQ1H85SYP internal analgesic

sodium salicylate sodium salicylate WIQ1H85SYP menstrual/diuretic analgesic

sodium salicylate sodium salicylate WIQ1H85SYP overindulgence in alcohol/food

Page 247 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

sodium salicylic acid phenolate sodium salicylic acid WIQ1H85SYP anorectal antiseptic phenolate

sodium sulfide (aqueous) sodium sulfide (aqueous) C02T02993U ingrown toenail gel vehicle

sodium thiosulfate sodium thiosulfate HX1032V43M acne

Sodium Thiosulfate 0.1N (0.1M) Sodium Thiosulfate 2.5%; 10102-17-7 Liquid USP, FDA approved injection CAS 497-19-8 0.02% Sodium Carbonate; CAS 7732-18-5 Water (balance)

Soft Paraffin Parafin Not USP unless by another name sols, secondary sols, secondary amyltricre oral health care

sols, secondary sols, secondary amyltricre antifungal

soopolamine hydrobromide soopolamine hydrobromide 451IFR0GXB antiemetic

sorbitol sorbitol 506T60A25R digestive aid

Page 248 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

sorbitol sorbitol 506T60A25R laxative hyperosmotic

sorbitol sorbitol 506T60A25R oral health care demeculents

Sotalol Sotalol Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010; 1284- 1289.

soy meal soy meal weight control

soybean oil, hydrogenated soybean oil, hydrogenated 241ATL177A cholecystokinetic (powder) (powder)

soybean protein soybean protein R44IWB3RN5 weight control

Spironolactone Spironolactone Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1289- 1290.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Spironolactone / Spironolactone and Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. Hydrochlorothiazide Hydrochlorothiazide form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1289- 1290.

Splenda sucralose based ? Aspartate Sodium? Squaric acid dibutyl ester Squaric Acid Di-N-Butyl Ester Liquid Not USP unless by another Federal Register 1999 (SADBE)? name

squill preparations (squill, squill squill preparations (squill, 3629601H5D cough/cold expectorant extract) squill extract)

stannous fluoride stannous fluoride 3FTR44B32Q anticaries dentrifrices

Page 250 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

stannous fluoride stannous fluoride 3FTR44B32Q anticaries dentrifrices

stannous fluoride stannous fluoride 3FTR44B32Q relief of oral discomfort

stannous fluoride (gel) stannous fluoride (gel) 3FTR44B32Q anticaries

stannous fluoride (rinse) stannous fluoride (rinse) 3FTR44B32Q anticaries

stannous pyrophosphate and zinc stannous pyrophosphate gingivitis/plaque citrate and zinc citrate

stearyl alcohol stearyl alcohol 2KR89I4H1Y skin protectant insect bites/stings w/ sales less than $25,000

stearyl alcohol stearyl alcohol 2KR89I4H1Y skin protectant poison ivy/oak/sumac w/ sales less than $25,000

stearyl alcohol stearyl alcohol 2KR89I4H1Y skin protectant w/ sales less than $25,000

stem bromelain stem bromelain ZLM4P8929R digestive aid

Page 251 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Sterile Water for Irrigation Sterile Water for Irrigation USP

Stevia Powder Extract, Min 90% Stevia Powder Not USP unless by another name strawberry strawberry 4J2TY8Y81V digestive aid

Strong Iodine Solution NDC 0395-0775-16 Liquid USP strontium chloride strontium chloride 5R78837D4A relief of oral discomfort

strontium chloride strontium chloride 5R78837D4A relief of oral discomfort

strychnine strychnine H9Y79VD43J digestive aid

sublimed sulfur sublimed sulfur 70FD1KFU70 anorectal keratolytic

sucros sucros C151H8M554 weight control

Sucrose Sucrose 57-50-1 Powder USP sucrose sucrose C151H8M554 menstrual/diuretic

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

sugars sugars oral health care demeculents

sulfacetamide sodium sulfacetamide sodium 4NRT660KJQ ophthalmic anti-infective

sulfADIAZINE Sulfadiazine FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010; 1300- 1301.

Sulfadimethoxine Sulfadimethoxine 122-11-2 USP Sulfamethoxazole, Micronized Sulfamethoxazole, 723-46-6 Powder USP, EP Micronized Sulfanilamide p-Anilinesulfonamide 63-74-1 USP sulfaSALAzine Sulfasalazine Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1304- 1305. sulferated oils of turpentine sulferated oils of turpentine menstrual/diuretic

Sulfobutylether B-Cyclodextrin Beta-Cyclodextrin 182410-00-0 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, sulfobutylether, sodium salt name eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

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sulfur sulfur 70FD1KFU70 acne

sulfur sulfur 70FD1KFU70 antifungal

sulfur sulfur 70FD1KFU70 dandruff

sulfur sulfur 70FD1KFU70 external analgesic poison ivy/oak/sumac

sulfur sulfur 70FD1KFU70 skin protectant

sulfur sulfur 70FD1KFU70 skin protectant diaper rash

sulfur sulfur 70FD1KFU70 skin protectant fever blister/cold sore

sulfur (when combined w/ sulfur (when combined w/ 70FD1KFU70 acne resorcinol, resorcinol resorcinol, resorcinol monoacetate) monoacetate)

Sulfur Precipitated Sulfur Precipitated 7704-34-9 Powder USP sulfur, sublimed sulfur, sublimed 70FD1KFU70 pediculicide

Page 254 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

sulisobenzone sulisobenzone 1W6L629B4K sunscreen

Supposibase-F (Fatty Acid) Hard Fat; C10-18 USP = Hard Fat, many Triglycerides monographs for Triglycerides

T3 Sodum Dilution (1:1000) T3 Sodum Dilution (1:1000) Not USP

Tacrolimus Monohydrate Tacrolimus 109581-93-3 Capsule USP, FDA approved capsule Taketomo CK, Hodding JH, Kraus DM. dosage form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1311- 1315.

Tadalafil Tadalafil Tablet, Powder FDA approved tablet dosage Tadalafil (Adcirca). [Package insert]. Eli Lilly form and Co., Indianapolis, IN. Revised April 2011.

talc talc 7SEV7J4R1U skin protectant astringent

talc talc 7SEV7J4R1U skin protectant diaper rash

Tamsulosin Tamsulosin Hydrochloride 106463-17-6 Capsule, USP, FDA approved capsule Lacy CF, Armstrong LL, Goldman MP, Lance powder dosage form LL. Drug Information Handbook. 20th ed. Hudson, Ohio. Lexi-Comp, Inc. 2011: 1558- 1559.

Page 255 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

tannic acid tannic acid 28F9E0DJY11 skin protectant diaper rash

tannic acid tannic acid 28F9E0DJY12 skin protectant fever blister/cold sore

tannic acid tannic acid 28F9E0DJY13 skin protectant poison ivy/oak/sumac

tannic acid tannic acid 28F9E0DJY14 skin protectant diaper rash

tannic acid tannic acid 28F9E0DJY14 skin protectant wound healing

tannic acid tannic acid 28F9E0DJY6 anorectal astringent

tannic acid tannic acid 28F9E0DJY7 antifungal

tannic acid tannic acid 28F9E0DJY10 external analgesic poison ivy/oak/sumac

tannic acid tannic acid 28F9E0DJY9 external analgesic fever blister/cold sore

Page 256 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

tannic acid diges tannic acid diges 28F9E0DJY8 digestive aid

tannic acid glycerite tannic acid glycerite 28F9E0DJY15 skin protectant astringent

taraxacum officinale taraxacum officinale menstrual/diuretic botanical/vegetable herb

tartaric acid tartaric acid W4888I119H laxative saline laxative

tartrate (acid or salt) tartrate (acid or salt) antacid

Taurine Taurin; L-Taurine 107-35-7 USP Federal Register 1999

Tea Tree Oil Melaleuca Oil; Oleum 68647-73-4 Oil Not USP unless by another Melaleucae; Melaleuca name Alternifolia (Tea Tree) Leaf Oil Teaberry Oil Teaberry Oil Not USP unless by another name

Page 257 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Temozolomide Temozolomide Capsule, FDA approved capsule dosage Taketomo CK, Hodding JH, Kraus DM. powder form Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 1315- 1318.

terpin hydrate preparations terpin hydrate preparations cough/cold expectorant (terpion hydrate, terpin hydrate (terpion hydrate, terpin elixer) hydrate elixer)

tetracaine tetracaine 0619F35CGV anorectal local

tetracaine tetracaine 0619F35CGV external analgesic & anesthetic

tetracaine tetracaine 0619F35CGV oral health care anesthetic/analgesic

Tetracaine Base Tetracaine Base 94-24-16 Powder USP Tetracaine Hydrochloride Tetracaine Hydrochloride 136-47-0 Powder USP

tetracaine hydrochloride tetracaine hydrochloride 5NF5D4OPCI acne

tetracaine hydrochloride tetracaine hydrochloride 5NF5D4OPCI anorectal local anesthetic

Page 258 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

tetracaine hydrochloride tetracaine hydrochloride 5NF5D4OPCI external analgesic

tetracaine hydrochloride tetracaine hydrochloride 5NF5D4OPCI first aid antibiotic ointment

tetracaine hydrochloride tetracaine hydrochloride 5NF5D4OPCI oral health care anesthetic/analgesic

Tetrafluoroethane (HFC) 1,1,1,2-Tetrafluoroethane 811-97-2 Not in USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

tetrahydrochloride tetrahydrochloride 0YZT43HS7D ophthalmic vasoconstrictor

thaimine hydrochloride (vitamin thaimine hydrochloride M572600E5P weight control B1) (vitamin B1)

thaimine mononitrate (vitamin B1 thaimine mononitrate 8K0I04919X weight control mononitrate) (vitamin B1 mononitrate)

Page 259 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Thaumatin Thaumatin 53850-34-3 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, name eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

thenyldiamine hydrochloride thenyldiamine hydrochloride 7ZQC1892H9 cough/cold antihistamine

thenyldiamine hydrochloride thenyldiamine hydrochloride 7ZQC1892H9 cough/cold nasal decongestant

theobromine sodium salicylate theobromine sodium menstrual/diuretic antihistamine salicylate

theophylline (in combination) theophylline (in C137DTR5RG cough/cold bronchodilator combination)

theophylline calcium salicylate theophylline calcium cough/cold bronchodilator salicylate

Theophylline Compound with Theophylline and Theophyline is in USP but not Ethylenediamine ethylenediamine the combo

Page 260 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

theophylline mens theophylline mens C137DTR5RG menstrual/diuretic antihistamine

theophylline sodium glycinate theophylline sodium cough/cold bronchodilator glycinate

theophylline, anhydrous theophylline, anhydrous 0I55128JYK cough/cold bronchodilator

Thiamine Thiamine Injection, FDA approved injection and OTC Taketomo CK, Hodding JH, Kraus DM. Powder dosage forms Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1338- 1339.

thiamine hydrochloride thiamine hydrochloride M572600E5P menstrual/diuretic

thiamine hydrochloride thiamine hydrochloride M572600E5P nighttime sleep aid

thimerosal thimerosal 2225PI3MOV antimicrobial first aid antiseptic

Thioctic Acid Lipoic acid; alpha lipoic acid 1200-22-2 Not USP unless by another name

Page 261 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

thiocyanoacetate thiocyanoacetate pediculicide

Thioguanine Thioguanine Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1339- 1340.

thonzylamine hydrochloride thonzylamine hydrochloride 6K9YKD48Y4 cough/cold antihistamine

Threonine Threonine; L-Threnonine 72-19-5 USP

threonine threonine 2ZD004190S weight control

thylene blue thylene blue T42P99266K menstrual/diuretic

thymol thymol 3J50XA376E acne

thymol thymol 3J50XA376E analgesic fever blister/cold sore

thymol thymol 3J50XA376E antifungal

Page 262 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

thymol thymol 3J50XA376E cough/cold nasal decongestant

thymol thymol 3J50XA376E dandruff

thymol thymol 3J50XA376E external analgesic & anesthetic

thymol thymol 3J50XA376E external analgesic poison ivy/oak/sumac

thymol thymol 3J50XA376E oral health care anesthetic/analgesic

thymol thymol 3J50XA376E relief of oral discomfort

thymol thymol 3J50XA376E skin protectant astringent

thymol (lozenge) thymol (lozenge) 3J50XA376E cough/cold nasal decongestant

Page 263 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

thymol (mouthwash) thymol (mouthwash) 3J50XA376E cough/cold nasal decongestant

Thymol iodide Dithymol Diiodide 552-22-7 Powder USP has Thymol CAS 89-83-8 Federal Register 1999

thymol iodide thymol iodide 3J50XA376E oral health care

thymol iodide thymol iodide 3J50XA376E relief of oral discomfort

Page 264 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Tinidazole Tinidazole 19387-91-8 USP, EP Federal Register 1999

titanium dioxide titanium dioxide 15FIX9V2JP sunscreen

tolindate tolindate 5236RK32KG antifungal

tolnaftate tolnaftate 06KB629TKV antifungal

Toltrazuril Toltrazuril 69004-03-1 Powder Not in USP tolu balsam tolu balsam TD2LE91MBE oral health care

tolu preparations (tolu, tolu tolu preparations (tolu, tolu TD2LE91MBE cough/cold expectorant balsam tincture) balsam tincture)

Tommygel Tommygel Not USP topical starch topical starch 08232NY3SJ anorectal protectant

Page 265 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

topical starch topical starch O8232NY3SJ external analgesic

topical starch topical starch O8232NY3SJ skin protectant

topical starch topical starch O8232NY3SJ skin protectant astringent

topical starch topical starch O8232NY3SJ skin protectant diaper rash

topical starch topical starch O8232NY3SJ skin protectant fever blister/cold sore

topical starch topical starch O8232NY3SJ skin protectant poison ivy/oak/sumac

Topiramate Topiramate Oral, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010; 1360- 1363.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Tramadol Hydrochloride Tramadol Hydrochloride 36282-47-0 Tablet, Powder USP, maybe EP

Tranexamic Acid trans-4- 1197-18-8 USP, BP (Aminomethyl)cyclohexanec arboxylic Acid; AMCA

Tranilast 2{[(2E)-3-(3,4- 53902-12-8 Not USP unless by another dimethyxyphenyl)prop-2- name enoyl]amino}benzoic acid

TraZODone Trazodone Hydrochloride Tablet, Powder FDA approved tablet dosage Trissel LA. Trissel's Stability of Compounded form Formulations, 4th ed. Washington, DC: American Pharmacists Association; 2009.

triacetin triacetin XHX3C3X673 antifungal

tricalcium phosphate tricalcium phosphate K4C08XP666 antacid

tricalcium phosphate tricalcium phosphate K4C08XP666 weight control

Page 267 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Tricaprylin 1,3-Di(octanoyloxy)propan-2-538-23-8 Not in USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, yl octanoate eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Trichloroacetic Acid Trichloracetic Acid, TCA 76-03-9 Crystals USP lists as Reagent, BP, Kuntz R. Sensitization Therapy for Warts. Int J Reagent ACS of Pharmaceutical Compounding 2003; 7(4): 266-270.

Trichloroacetic Acid, 100% (w/v) Trichloracetic Acid, TCA Solution Listed in Reagents: P and D in Aqueous Solution USP Trichloroacetic Acid, 30% (w/v) Trichloracetic Acid, TCA Solution Listed in Reagents: P and D in Aqueous Solution USP Trichloroacetic Acid, 30% (w/v) Trichloracetic Acid, TCA Solution Reagent, ACS Aqueous Solution Trichloroacetic Acid, 50% (w/v) Trichloracetic Acid, TCA Solution Listed in Reagents: P and D in Aqueous Solution USP Trichloroacetic Acid, 85% (w/v) Trichloracetic Acid, TCA Solution Listed in Reagents: P and D in Aqueous Solution USP triclocarban triclocarban BGG1Y1ED0Y antimicrobial

triclocarban triclocarban BGG1Y1ED0Y antimicrobial

Page 268 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

triclocarban triclocarban BGG1Y1ED0Y antimicrobial

triclosan triclosan 4NM5039Y5X antimicrobial

Page 269 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

triclosan triclosan 4NM5039Y5X antimicrobial

Triethanolamine Tris(2-hydroxyethyl)amine 102-71-6 USP lists in assay section of several monographs Triglycerides C10-18 Triglycerides Not USP trillium trillium digestive aid

Trilostane Trilostane 13647-35-3 Not in USP Trimethoprim Trimethoprim Tablet, Powder FDA approved tablet dosage Taketomo CK, Hodding JH, Kraus DM. form Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010; 1416- 1419.

Page 270 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Triolein 2,3-bis[[(Z)-octadec-9- 122-32-7 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, enoyl]oxy]propyl (Z)- name eds. Handbook of Pharmaceutical Excipients. octadec-9-enoate 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

tripelennamine hydrichloride tripelennamine FWV8GJ56ZN external analgesic hydrichloride

tripelennamine hydrochloride tripelennamine FWV8GJ56ZN external analgesic fever blister/cold sore hydrochloride

triple dye triple dye antimicrobial

Page 271 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

triple dye triple dye antimicrobial

triprolidine hydrochloride triprolidine hydrochloride YAN7R5L890 cough/cold antihistamine

triticum triticum 8K1MK5E1FY menstrual/diuretic

trolamine trolamine 9O3K93S3TK external analgesic

trolamine trolamine 9O3K93S3TK skin protectant fever blister/cold sore

trolamine trolamine 9O3K93S3TK skin protectant insect bites/stings

trolamine trolamine 9O3K93S3TK skin protectant poison ivy/oak/sumac

Page 272 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

trolamine salicylate trolamine salicylate H8O4040BHD external analgesic fever blister/cold sore (triethanolamine salicylate) (triethanolamine salicylate)

trolamine salicylate trolamine salicylate H8O4040BHD external analgesic insect bite/sting (triethanolamine salicylate) (triethanolamine salicylate)

trolamine salicylate trolamine salicylate H8O4040BHD external analgesic poison ivy/oak/sumac (triethanolamine salicylate) (triethanolamine salicylate)

trolamine salicylate trolamine salicylate H8O4040BHD sunscreen (triethanolamine salicylate) (triethanolamine salicylate)

Tryptophan Tryptophan; L-Tryptophan 73-22-3 USP

tryptophan tryptophan 8DUH1N11BX weight control

turpentine oil turpentine oil XJ6RUH0O4G external analgesic fever blister/cold sore

turpentine oil turpentine oil XJ6RUH0O4G external analgesic poison ivy/oak/sumac

turpentine oil turpentine oil XJ6RUH0O4G external insect bite/sting

Page 273 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

turpentine oil turpentine oil XJ6RUH0O4G skin protectant insect bites/stings w/ sales less than $2

turpentine oil turpentine oil XJ6RUH0O4G skin protectant poison ivy/oak/sumac

turpentine oil (oral) turpentine oil (oral) XJ6RUH0O4G cough/cold antitussive

turpentine oil (rectified) turpentine oil (rectified) XJ6RUH0046 anorectal counterirritant

turpentine oil (spirits of turpentine oil (spirits of XJ6RUH0O4G cough/cold expectorant turpentine) turpentine)

turpentine oil (spirits of turpentine oil (spirits of XJ6RUH0O4G cough/cold nasal decongestant turpentine) (oral) turpentine) (oral)

turpentine oil (spirits of turpentine oil (spirits of XJ6RUH0O4G cough/cold nasal decongestant turpentine) (topical) turpentine) (topical)

turpentine oil (topical) turpentine oil (topical) XJ6RUH0O4G cough/cold antitussive

turpentine, venice (venice turpentine, venice (venice AD8LJ73GQF menstrual/diuretic turpentine) turpentine)

Tylosin Tartrate Tylosin Tartrate 1405-54-5 Powder USP, EP

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tyrosine tyrosine 42HK56048U weight control

uinolinium bromide uinolinium bromide alkyl isoq dandruff

ulose ulose alpha cell laxative bulk laxative

undecoylium chlorideiodine undecoylium chlorideiodine antimicrobial compolex compolex

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undecoylium chlorideiodine undecoylium chlorideiodine antimicrobial compolex compolex

undecylenic acid undecylenic acid K3D86KJ24N antifungal

undecylenic acid undecylenic acid K3D86KJ24N dandruff

Urea Urea 57-13-6 Crystals USP-NF Lacy CF, Armstrong LL, Goldman MP, Lance LL. Drug Informatoin Handbook. 20th ed. Hudson, Ohio. Lexi-Comp, Inc. 2011: 1669- 1670.

urea urea 8W8T17847W menstrual/diuretic

Ursodiol UDCA; Ursodeoxycholic 128-13-2 Capsule, USP, EP, FDA approved dosage Taketomo CK, Hodding JH, Kraus DM. Acid; 3alpha, 7Beta- powder form Pediatric Dosage Handbook. 17th ed. Dihydroxy-5Beta-cholan-24- Hudson, Ohio. Lexi-Comp, Inc. 2010; 1393- oic acid 1394.

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uva ursi, extract of uva ursi, extract of 3M5V3D1X36 menstrual/diuretic

uva ursi, potassium extract uva ursi, potassium extract weight control

valACYclovir Valcyclovir Tablet, Powder FDA approved tablet dosage Nadal D, Leverger G, Sokal EM, et al. An form Investigation of the Steady-State Pharmacokinetics of Oral Valacyclovir in Immunocompromised Children. J Inf Dis 2002; 186 (Suppl1): S123-30.

Valic Acid Valic acid; L-Valic acid 17407-55-5 Not USP unless by another name Valine Valine, L-Valine 72-18-4 Powder USP valine valine HG18B9YRS7 weight control

Vanadium Nicotinate Glycinate Vanadium Nicotinate USP Glycinate Vancomycin Vancomycin Injection, Oral FDA approved injection and Taketomo CK, Hodding JH, Kraus DM. capsule dosage forms Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 1404- 1407.

vegetable (green) vegetable (green) 9ZP99WL196 weight control

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Verapamil Verapamil Tablet, Powder Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: pgs. 1416-1419.

vitamin A vitamin A 81G40H8B0T anorectal wound healing

vitamin A vitamin A 81G40H8B0T corn/callus remover

vitamin A vitamin A 81G40H8B0T skin protectant diaper rash

vitamin A vitamin A 81G40H8B0T weight control

vitamin A acetate vitamin A acetate weight control

vitamin A palmitate vitamin A palmitate weight control

Vitamin A Palmitate, in Corn Oil Retinol Palmitate 79-81-2 Oil USP has Viotamin A Oral Liquid Preparation, EP Vitamin D3 in Corn Oil Vitamin D3 in Corn Oil Oil USP?

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vitamin E vitamin E H4N855PNZ1 acne

vitamin E vitamin E H4N855PNZ1 nighttime sleep aid

vitamin E vitamin E H4N855PNZ1 stimulant

vitamin E vitamin E H4N855PNZ1 weight control

vitromersol vitromersol antimicrobial first aid antiseptic

water and additives water and additives ophthalmic

water, purified water, purified 059QF0KO0R ophthalmic

Wax, Anionic Emulsifying Anionic emulsifying wax 8014-38-8 BP, PhEur; Not USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012.

Wax, Paraffin Paraffin Wax 8002-74-2 USP?

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wax, white wax, white 7G1J5DA97F ophthalmic emollient

wax, yellow wax, yellow 2ZA36H0S2V ophthalmic emollient

wheat germ wheat germ YR3G369F5A weight control

white ointment white ointment ophthalmic emollient

white petrolatum white petrolatum 4T6H12BN9U anorectal protectant

witch hazel (haramelis water) witch hazel (haramelis 1014J0U34 anorectal astringent water)

witch hazel skin witch hazel skin 101I4J0U34 skin protectant astringent

woodruff woodruff N8C4A9A49H digestive aid

Xanthan Gum Xanthan Gum 11138-66-2 Powder USP? xanthan gum xanthan gum TTV12P4NEE weight control

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xylometazoline hydrochloride xylometazoline X5S84033NZ cough/cold nasal decongestant hydrochloride

xylometazoline hydrochloride xylometazoline X5S84033NZ cough/cold nasal decongestant (aqueous) hydrochloride (aqueous)

xylometazoline hydrochloride xylometazoline X5S84033NZ cough/cold nasal decongestant (jelly) hydrochloride (jelly)

yeast yeast 3NY3SM6B8U weight control

yeast cell derivative, live yeast cell derivative, live 3NY3SM6B8U skin protectant diaper rash

yeast cell derivative, live yeast cell derivative, live 3NY3SM6B8U skin protectant wound healing agent

yellow mercuric oxide yellow mercuric oxide IY191986AO ophthalmic anti-infective

Zinc Zinc 84-02-6 Powder USP has Zinc Oxide and Sulfate

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zinc acetate zinc acetate FM5526K07A skin protectant

zinc acetate zinc acetate FM5526K07A skin protectant diaper rash

zinc acetate zinc acetate FM5526K07A skin protectant wound healing agent

zinc acetate zinc acetate FM5526K07A external analgesic

zinc caprylate zinc caprylate QL5435GI2S antifungal

zinc carbonate zinc carbonate EQR32Y7H0M skin protectant

zinc carbonate zinc carbonate EQR32Y7H0M skin protectant diaper rash

zinc chloride zinc chloride 86Q357L16B corn/callus remover

zinc chloride zinc chloride 86Q357L16B oral health care

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zinc chloride zinc chloride 86Q357L16B skin protectant astringent

zinc citrate zinc citrate K72I3DEX9B gingivitis/plaque

zinc oxide zinc oxide SOI2LOH54Z acne

zinc oxide zinc oxide SOI2LOH54Z external analgesic

zinc oxide zinc oxide SOI2LOH54Z external analgesic insect bite/sting

zinc oxide zinc oxide SOI2LOH54Z n/a

zinc oxide zinc oxide SOI2LOH54Z sunscreen

zinc oxide zinc oxide SOI2LOH54Z anorectal astringent

zinc oxide zinc oxide SOI2LOH54Z skin protectant

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zinc oxide zinc oxide SOI2LOH54Z skin protectant astringent

zinc oxide (combination only) zinc oxide (combination SOI2LOH54Z anorectal protectant only)

Zinc Oxide paste 25% Zinc Oxide paste 25% 1314-13-2? Paste USP zinc phenol sulfonate zinc phenol sulfonate 4O71YT5YB5 sunscreen

zinc phenolsulfonate zinc phenolsulfonate 4O71YT5YB5 antidiarrheal

zinc phenolsulfonate zinc phenolsulfonate 4O71YT5YB5 antiemetic

zinc phenolsulfonate zinc phenolsulfonate 4O71YT5YB5 skin protectant astringent

Zinc Picolinate Zinc Picolinate 17949-65-4 Not in USP zinc propionate zinc propionate antifungal

Zinc Pyrithione (48%) Zinc Pyrithione (48%) 13463-41-7 Not in USP zinc stearate zinc stearate H92E6QA4FV acne

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zinc stearate zinc stearate H92E6QA4FV skin protectant astringent

Zinc Sulfate Zinc Sulfate Zinc Sulfate FDA Approved injection dosage Norwood C, Chaney B, Moore RW. Managing Injection, form, OTCs Zinc Deficiency in an Office Setting. IJPC 4(6): Powder, 440-441. Tablet, Capsule

zinc sulfate zinc sulfate 89DS0H96TB ophthalmic astringent

zinc sulfate zinc sulfate 89DS0H96TB poison treatment

zinc sulfate zinc sulfate 89DS0H96TB external analgesic fever blister/cold sore

zinc sulfate zinc sulfate 89DS0H96TB skin protectant astringent

zinc sulfate zinc sulfate 89DS0H96TB skin protectant fever blister/cold sore

zinc sulfide zinc sulfide 89DS0H96TB acne

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zinc undecylenate zinc undecylenate 388VZ25DUR antifungal

zirconium oxide zirconium oxide external analgesic insect bite/sting

zirconium oxide zirconium oxide external analgesic poison ivy/oak/sumac

zirconium oxide zirconium oxide skin protectant insect bites/stings

zirconium oxide zirconium oxide skin protectant poison ivy/oak/sumac

Zonisamide Zonisamide Tablet, Powder FDA approved capsule dosage Zonisamde. [Package insert]. Eisai Inc., form Woodcliff Lake, NJ, April 2009

zyloxin zyloxin antimicrobial first aid antiseptic

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zyloxin zyloxin skin protectant poison ivy/oak/sumac

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Bibliographies on Safety and Bibliographies on Safety and Efficacy Data Bibliographies on Safety and Efficacy Data Efficacy Data

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 43- 45.

Bibliography Panel Pending

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 Amin JH, et al. Arginine supplementation prevents necrotizing enterocolitis in the premature infant. J Pediatr 2002 Apr; 140(4): 425-31.

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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Gordon J, McLeod JW, Mayr-Harting A, Orr JW, Zinnemann K. Black EH, et al. (eds.). Smith and Nesi's Ophthalmic Granick MS, Heckler FR, Jones EW. Surgical The Value of antiseptics as Prophylactic applications to recent Plastic and Reconstructive Surgery. Springer skin-marking techniquies. Plast Reconstr Surg wounds. J of Hygiene 1947; 45(3): 297-306. Science+Business Media, LLC. 2012. Zoumalan CI, Eliasich 197 Apr; 79(4): 573-80. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2234848/pdf K, Lolli Jr GJ, Chapter 4: Instrumentation in Ophthalmic /jhyg00184-0050.pdf Accessed 12-28-2011. Plastic Surgery, page 97.

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 Bertz H, Afting M, Kreisel W, Duffner U, Greinwald R, Finke J. Ibrahim RB, Abidi MH, Cronin SM, Lum LG, Al-Kadhimi Z, Feasibiilty and response to budesonide as topical et al. Nonabsorbable Corticosteroids Use in the corticosteroid therapy for acute intestinal GVHD. BMT (1999) Treatment of Gastrointestinal Graft-versus-Host Disease. 24, 1185-1189. Biol Blood Marrow Transplant 15: 395-405 (2009).

Bertz H, Afting M, Kreisel W, Duffner U, Greinwald R, Finke J. Ibrahim RB, Abidi MH, Cronin SM, Lum LG, Al-Kadhimi Z, Feasibiilty and response to budesonide as topical et al. Nonabsorbable Corticosteroids Use in the corticosteroid therapy for acute intestinal GVHD. BMT (1999) Treatment of Gastrointestinal Graft-versus-Host Disease. 24, 1185-1189. Biol Blood Marrow Transplant 15: 395-405 (2009).

Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 222- 223.

Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage It is recommended that the same batch be used for the Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 223- entire course of therapy. Doses should be drawn up into 225. a syringe to prevent underdosing. Warm to room temperature. Flush NG tube with 10 mL water.

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 Moed L, Shwayder TA, Chang MW. Cantharidin Revisited: a de Bengoa Vallejo RB, Iglesias MEL, Gomez-Martin B, blistering defense of an ancient medicine. Arch Dermatol Gomez RS, Crespo AS. Application of Cantharidin and 2001; 137: 1357-1360. Podophyllotoxin for the Treatment of Plantar Warts. J Am Podiatr Med Assoc 98(6): 445-450, 2008.

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, Inc. 2010: 242- 244.

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 Cunniff CM. Smith-Lemli-Opitz Syndrome (RSH Syndrome, SLO Syndrome, SLOS) Gene Reivew.org Accessed 3-31-2008.

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Desitin (40% Zinc Oxide Diaper Rash Paste). [Product Nystatin Topical Powder, USP. [Package insert]. Paddock Container]. Johnson & Johnson Consumer Products Company. Laboratories, Inc., Minneapolis, MN. Revised 10-2007. Skillman, NJ. CCI 2008.

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Upitis JA, Krol A. The Use of Diphenylcyclopropenone in the Khandpur S, Sharma VK, Sumanth K. Topical Federal Register 1999 Treatment of Recalcitrant Warts. J Cutan Med Surg. 2002: 214- Immunodulators in dermatology. J Postgrad Med June 217. 2004: 50(20; 131-139.

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FDA approved products.

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Ikezuagu G, Ndefo UA. Oral Mocositis: Update on Prevention and Management Strategies. US Pharm 2009; 34(1)(Oncology suppl): 10-14.

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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Flint: Cummings Otolarynology: Head & Neck Surgery 5th ed. Chapter 138 (UTSW Mastoid Powder)

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 Koren G, et al. Systemic exposure to mercaptopurine as a prognostic factor in acute lymphoblastic leukemia in children. N Engl J Med 1990; 323: 17-21.

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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Miller MK, Dowd MD, Fraker M. Emergency Department Walker M, Warner BW, Brilli Rj, Jacobs BR. Hansen SE, Whitehill JL, Goto CS, Quintero CA, Management and Short-Term Outcome of Children with Cardiopulmonary Compromise Associated with Milk and Darling BE, Davis J. Safety and Efficacy of Milk Constipation. Pediatric Emergency Care 2007; 23: 1-4. Molasses Enema Use in Children. J of Pediatric and Molasses Enemas Compared With Gastroenterology and Nutrition 2003; 36: 144-148. Sodium Phosphate Enemas for the Treatment of Constipation in a Pediatric Emergency Department. Pediatric Emergency Care 2011; 27(12): 1118-1120.

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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Lacy CF, Armstrong LL, Goldman MP, Lance LL. Drug Zellos A, Roy A, Schwarz KB. Use of oral naltrexone for Lindor KD, Gershwin ME, Poupon R, et al. Information Handbook, 17th ed. Hudson, Ohio, Lexi-Comp, severe pruritus due to cholestatic liver disease in American Association for Study of Liver Inc. 2008: 1084-1085. children. JPGN 2010; 51: 787-789. Diseases. Primary biliary cirrhosis. Hepatology 2009; 50: 292-308.

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Children's Medical Center Policy, Pathology Department Technical Document: Sweat Chloride Analysis No. HM 16.07.

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Primaquine Phosphate Tablets, USP. [Package insert]. Sanofi- Aventis U.S. LLC., Bridgewater, NJ. Revised November 2010.

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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Lacy CF, Armstrong LL, Goldman MP, Lance LL. Drug Information Handbook. 20th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 1433-1434.

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Kothari SS, Duggal B. Chronic oral Sildenafil therapy in severe Cholfrani HA, Wiedemann R, Rose F, Olschewsk H, pulmonary artery hypertension. Indian Heart Journal 2002; Schermuly RT, Weismann N, et al. Sildenafil (Viagra) may 54: 404-409. help improve control of pulmonary hypertension. Annals of Internal Medicine 2 April 2002; 136; 54: 404-409.

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

Haemel AK, O'Brian AL, Teng JM. Topical Rapamycin: A Novel Approach of Facial Angiofibromas in Tuberous Sclerosis. Arch Dermatol July 2010; 146(7): 715-718.

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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Children's Medical Center Policy, Pathology Department Technical Document: Sweat Chloride Analysis No. HM 16.07.

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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<795> United States Pharmacopeial Convention, Inc. United States Pharmacopeia 34-National Formulary 29. Rockville, MD: US Pharmacopeial Convention, Inc.; 2011: 330-337.

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

Goto T, Kino T, Hatanaka H, Pkuhara M, Kohsaka M, Aoki H, et al. FK506; historical perspectives. Transplant Prac 1991; 23: 2713-2717.

Takatsuki S, Calderbank M, Ivy DD. Initial Experience With Lacy CF, Armstrong LL, Goldman MP, Lance LL. Drug Tadalafil in Pediatric Pulmonary Arterial Hypertension. Pediatr Information Handbook. 20th ed. Hudson, Ohio. Lexi- Cardiol 2012 Mar 9. [Epub ahead of print]. Comp, Inc. 2010: 1552-1555.

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Children's Oncology Group Protocol: AADVL0918 A Phase 1 Study of Temsirolimus in Combination with Irinotecan and Temozolomide in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Tumors.

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 Pascual J, Sanchez del Rio M, Mateos V, Lainez JM, Hernandez- Cutrer FM, Silberstein SD, Mathew NT, Rozen TD. Gallego J, Leira R, Jimenez MD. Topiramate for patients with Antiepileptic drugs in the management of cluster refractory migraine: an observational, multicenter study in headache and trigeminal neuralgia. Headache 2001 Nov- Spain. Neurologia 003 Sep; 18(7): 364-367. Dec; 41 Suppl 1: S25-33. Review.

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Levine PJ. Chemical Facial Peel Formulations. Int J of Cook KK, Cook WR. Chemical Peel of Nonfacial Skin Using Pharmaceutical Compounding 1999; 3(5): 375-377. Glycolic Acid Gel Augmented with TCA and Neutralized Based on Visual Staging. Dermatologic Surgery 2000; 26: 994-999.

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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Scottish Rite Hospital of Dallas prescribes a lot

FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010 Mixon W, Angelle P, Yoch D. Compounding for Pediatric Nakamura T, Nishiyama S, Futagoishi-Suginohara Y, Anderson LA, Hakojarvi St, Boudreaux SK. Zinc Patients: Case Reports and Formulations. IJPC 8(1): 6-12. Matsuda I, Higashi A. Mild to moderate zinc defiency in Acetate Treatment in Wilson's Disease. Ann short children: effect of zinc supplementation on linear Pharmacother 1998; 32: 78-87. growth velocity. J Pediatr 1993 Jul; 123(1): 65-69.

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FDA. OTC Active Ingredients List. http://www.fda.gov/downloads/AboutFDA/CentersOffices/C DER/UCM135688.pdf Accessed 2-10-2014, last updated April 7, 2010

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Final Compounded Rationale for Why There is a Clinical Need to Use Final Compounded Formulation Final Compounded Formulation Dosage Form(s) Bulk Substance Formulation Strength Route(s) of Administration

4-Aminopyridine (4-AP), which is well characterized chemically, is a potassium channel blocker that may enhance the release of acetylcholine from nerve terminals. It has been used to treat several neurological disorders, including Lambert-Eaton myasthenic syndrome, multiple sclerosis, and Alzheimer’s disease. It also has been used to reverse the effects of nondepolarizing muscle relaxants. At doses reported in the literature, the side effects of 4-AP for most patients do not appear to be serious. However, there have been some reports of seizures associated with the use of 4-AP. FDA would like more information about the historical use, safety, and effectiveness of 4-AP before deciding whether to propose it for inclusion on the bulk drugs list. The Pharmacy Compounding Advisory Committee similarly expressed a desire for more information about 4-AP before making a recommendation about its status to the agency. FDA is soliciting public input on these and any other issues that are relevant to the agency’s consideration of this substance for the bulk drugs list. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.(1)

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Sweetener Various Various Various

Various Various Various

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Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 25 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Antimicrobial preservative; antioxidant for injectables and solution inhalers.

Commercial API Acetylcysteine 10% Solution for Oral or Inhalation Oral Solution 10% (100 mg / mL) Oral repackaged for oral use at home. There has been a great shortage of this commercial product, the API may need to be used to prepare a nonsterile oral solution.

Commercial Acetylcysteine 20% Solution for Oral or Inhalation for Oral Solution 20% (200 mg / mL) Oral oral use at home. There has been a great shortage of this medication, the API may have to be used to prepare an oral solution.

Final FR Citation

Various Various Various

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Various Various Various

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Various Various Various

Biocompatible material; biodegradable materia; microencapsulating agent; modified-release agent used as carriers in many types of sustained-release implantable or injectable drug- delivery systems for both human and veterinryr use. Examples of implantable drug delivery systems include rods, cyliders, tubing, films, fibers, pellets, microcapsules, microspheres, nnoparticles, and liuqid injectable controlled-release systems such as gel formulations.

Sweetening agent developed in the early 1980s, approximately 2,000 times sweeter than sucrose. Used in a wide range of foods and beverages at a maximum level of 40-300 mg/kg.

Various Various Various

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Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 20 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

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Various Various Various

Base G Various Various Various

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Adsorbent, vaccine adjuvant ued in parenteralhuman and veterinary vaccines. It activates Th2 immune responses, including IgG and IgE antibody responses.

Various Various Various

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Various Various Various

Adsorbent, vaccine adjuvant ued in parenteral human and veterinary vaccines. It activates Th2 immune responses, including IgG and IgE antibody responses.

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Various Various Various

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Various Various Various

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Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Solution 1 mg / mL Oral Solution liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 5 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 1 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

Emulsifying agent; film-forming agent; humectant; viscosity- increasing agent used as such in pharmaceutical preparations.

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Various Various Various

Oral Solution 5 mEq/mL Oral

Various Various Various

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Various Various Various

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Various Various Various

Capsule contents emptied and crushed or API mixed with an oral Oral Suspension 20 mg / mL Oral vehicle to prepare an oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

API in SWFIrrigation to prepare an oral liquid for patients unable to Oral Solution 100 mg / mL Oral swallow a solid oral dosage form. There is an injectable Arginine available in the US market and some OTC products available that are either not appropriate for pediatric patients or difficult to procure.

Various Various Various

Treatment of amino acid deficienty.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Solution 2 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Various Various Various

Widely used as an adsorbent in solid dosage forms. Colloidal clays (such as attapulgite) absorb considerable amounts of water to form gels and in concentrations of 2-5% w/v usually form oil-in- water emulsions.

Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 10 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

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Various Various Various

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Various Various Various

API in oil vehicle in to prepare an oral solution for patients with Oral Solution 0.5 mg / mL Oral Graft Versus Host Disease (GVHD).

Also known as yellow wax. Various Various Various

Various Various Various

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Various Various Various

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Various Various Various

Preservative

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Betahistine dihydrochloride is a chemically well characterized histamine analog. Formerly marketed as Serc tablets, betahistine dihydrochloride was approved by FDA to treat the symptoms of vertigo in patients with Meniere’s disease. In 1970, however, FDA withdrew approval of the new drug application for Serc tablets because they were found to lack substantial evidence of effectiveness for this approved indication (see 35 FR 17563, November14, 1970). FDA will consult with the Pharmacy Compounding Advisory Committee at a future meeting about whether to include betahistine dihydrochloride on the bulk drugs list and will address the effect of its withdrawal from the market at that time. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.(1)

Various Various Various

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Tablet crushed or API mixed with an oral vehicle to prepare an oral SORBITOL FREE Oral Suspension 1 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

API in SWFIrrigation to prepare an oral liquid for patients unable to Oral Solution 25 mg / mL Oral swallow a solid oral dosage form. The OTC products may not be suitable for pediatric patients.

Various Various Various

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Various Various Various

Bismuth citrate is well characterized chemically. It has been used extensively in compounded products for short-term treatment of several gastrointestinal disorders, including Helicobacter pylori- associated ulcers. At doses reported in the literature for these indications, bismuth citrate appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of bismuth citrate’s effectiveness for these indications is also reported in the literature.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Brilliant Green and Gential Violet mixed to form Bonney & Topical Solution Topical Solution Browning Paint used for fine marking of the face prior to cleft pallet surgery.

Various Various Various

As an antimicrobial preservative in 0.01-0.1% w/v either alone or in combination with other preservatives in topical pharmaaceutical formulations, cosmetics, and toiletries; the usual concentration is 0.02% w/v.

Various Various Various

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Various Various Various

Oral Suspension 0.5 mg / mL Oral

API in SWFIrrigation to prepare an oral liquid for patients unable to Oral Suspension 2.5 mg / mL Oral swallow a solid oral dosage form. There is no commercial liquid available in the United States.

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 2 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

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Various Various Various

An emollient for topical emulsions, lotions and creams normally up to 3.7%. Used as a plasticizer in film-coating formulations of ethylcellulose and as a flavoring agent in foods.

As a solvent and co-solvent for injectables. Used in topical ointments, lotions and creams and as a vehicle in transdermal patches. A good solvent for many pharmaceuticals, especially estrogenic substances. Exerts its best antimicrobial efects at approximately 8% concentration in an oil-in-water emulsion. Concentrations above 16.7% are required to inhibit fungal growth.

Various Various Various

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Various Various Various

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Caffeine citrate is well characterized chemically. As a central nervous system stimulant, caffeine citrate has been used extensively and for many years in compounded products to treat apnea in premature infants. At doses reported in the literature for this indication, caffeine citrate appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of caffeine citrate’s effectiveness for this indication is also reported in the literature.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

API in Flexible Collodion. Cantharidin, which is well characterized Topical Solution 0.7% Topical chemically, is a substance obtained from the Chinese blister beetle, among other beetle species, that has been used topically in the treatment of warts and molluscum contagiosum, often in patients with compromised immune systems. Limited anecdotal evidence of cantharidin’s effectiveness for these indications is reported in the literature. Although cantharidin is an extremely toxic substance, it is apparently used only in the professional office setting and not dispensed for home use. Because of cantharidin’s toxicity, FDA is proposing to include it on the bulk drugs list for topical use in the professional office setting only.

Various Various Various

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Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Liquid 1 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

There is a USP monograph for Carbamide Peroxide CAS 124-43-6

Various Various Various

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Various Various Various

A high molecular weight polymer of acrylic acid cross-linked with allyl ethers of pentaerythritol. Used as a suspending and / or viscosity-increasing agent in gels. Carbomer is mentioned in USP <1151> Pharmaceutical Dosage Forms as used in single-phase gels.

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Elegant, non-greasy carbomer gel base suitable for many dermatological and cosmetic applications. Carbomer is mentioned in USP <1151> Pharmaceutical Dosage Forms as used in single- phase gels. Quick drying alcohol based carbomer gel vehicle suitable for dermatologic and cosmetic use; non-greasy, non-film-forming. Carbomer is mentioned in USP <1151> Pharmaceutical Dosage Forms as used in single-phase gels.

Various Various Various

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Various Various Various

Tablets crushed or API mixed in sterile water for irrigation, Ora- Oral Suspension 1 mg / mL Oral Plus and Ora-Sweet to prepare an oral liquid for patients unable to swallow a solid oral dosage form.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Oral Suspension 50 mg / mL Oral

Various Various Various

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Various Various Various

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Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 50 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US. ***MAY ONLY USE IF COMMERCIAL PRODUCT IS UNAVAILABLE** --ATTACH A COPY OF THE WHOLESALERS NOTIFICATION SHOWING BACKORDERED, DISCONTINUED OR OUT-OF-STOCK PRODUCT--

Various Various Various

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Smith-Lemli-Opitz Syndrome (SLOS) is a congenital multiple Oral Suspension 150 mg / mL Oral anomaly syndrome caused by an abnormality in cholesterol metabolism resulting from deficiency of the enzyme 7- dehydrocholesterol (7-DHC) reductase.

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Topical Ointment N/A Topical

Various Various Various

Choline bitartrate is well characterized chemically. It has been used to treat Alzheimer’s-type dementia. It has also been used to treat infantile colic. At doses reported in the literature for these indications, choline bitartrate appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of choline bitartrate’s effectiveness for these indications is also reported in the literature. Additionally, FDA has previously established that choline bitartrate is generally recognized as safe, as a dietary supplement, when used in accordance with good manufacturing practices (see 21 CFR 182.8250 (45 FR 58837, September 5, 1980)).

Various Various Various

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Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 0.1 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Oral Suspension 5 mg / mL Oral

Various Various Various

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Various Various Various

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Nuclear

Various Various Various

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Topical Solution 2:01 Topical

Various Various Various

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Various Various Various

A binder and coating agent in both oral capsules and tablets. Has been used to preare microcapsules for the controlled release of both aspirin and diltiazem. Widely used in cosmetics (lipstick, mascara, depilatories, hair tonics, and shampoos). Used as a coating agent on fruits and can linings, for density adjustment of citrus oils in beverages and as polishing agents for roasted coffee beans.

Various Various Various

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This mixture can be used in both capsules and tablets to improve flowability, enhance disintegration, and improve hardness.

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Cyclandelate, which is well characterized chemically, is vasodilator that was formerly approved by FDA for two indications: (1)Treatment for intermittent claudication caused by arteriosclerosis obliterans, and (2) as a treatment for cognitive dysfunction in patients suffering from senile dementia of the multi- infarct or Alzheimer’s type. Cyclandelate was formerly marketed in Cyclospasmol capsules and tablets, which were removed from the market for lack of effectiveness for these approved indications (see 61 FR 64099, December3, 1996). FDA will consult with the Pharmacy Compounding Advisory Committee at a future meeting about whether to include cyclandelate on the bulk drugs list and will address the effect of its withdrawal from the market at that time. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.(1)

Various Various Various

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Oral Solution 10 mg / mL Oral

Various Various Various

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Capsule contents emptied and crushed or API mixed with an oral Oral Suspension 5 mg / mL Oral vehicle to prepare an oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US. Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 2 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

Used as an emollient in pharmaceutical creams and lotions for skin and personal care products. It has been evaluated as a skin penetration enhancer for flurbiprofen. Has been used in combination with carnauba wax as an encapsulation system for inorganic sunscreens.

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API placebo to be used by Child Life in training children to swallow Capsules #0 Oral medication.

API placebo to be used by Child Life in training children to swallow Capsules #00 Oral medication.

API placebo to be used by Child Life in training children to swallow Capsules #000 Oral medication.

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API placebo to be used by Child Life in training children to swallow Capsules #1 Oral medication.

API placebo to be used by Child Life in training children to swallow Capsules #2 Oral medication.

API placebo to be used by Child Life in training children to swallow Capsules #3 Oral medication.

API placebo to be used by Child Life in training children to swallow Capsules #4 Oral medication.

API to prepare injectable solutions that have been on short supply. Injection 5, 10, 50 and 70% Intravenous

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The drug substance 3,4-Diaminopyridine (DAP),which is well http://www.fda.gov/ohrms/dockets/dockets/98n0182/nom004b.pdf Accessed 2- characterized chemically, is a potassium channel blocker that may 13-2014 enhance the release of acetylcholine from nerve terminals. DAP has been used in the treatment of several neuromuscular disorders, including Lambert-Eaton myasthenia syndrome, myasthenia gravis, amyotrophic lateral sclerosis, and multiple sclerosis. At doses reported in the literature, DAP appears to be well tolerated and its toxicity appears to be dose related. There have been reports of seizures with its use, however, and DAP is contraindicated in patients with epilepsy. FDA would like more information about the historical use, safety, and effectiveness of DAP before deciding whether to propose it for inclusion on the bulk drugs list. The Pharmacy Compounding Advisory Committee similarly expressed a desire for more information about DAP before making a recommendation about its status to the agency. FDA is soliciting public input on these and any other issues that are relevant to the agency’s consideration of this substance for the bulk drugs list. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.(1)

Various Various Various

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Used as an emollient in topical creams, emulsions, and solutions. Penetration enhancer and plasticizing agent.

Various Various Various

A hydrofluorocarbon (HFC) limited to use as an aerosol propellant in topical pharmaceutical formulations.

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Various Various Various

Diloxanide furoate is well characterized chemically. It has been used to treat parasitic diseases such as intestinal amoebiasis. At doses reported in the literature for these indications, diloxanide furoate appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of diloxanide furoate’s effectiveness for these indications is also reported in the literature.

Various Various Various

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Dimercapto-1-propanesulfonic acid (DMPS), a chelating agent, is well characterized chemically. DMPS has been used to treat heavy metal poisoning. At doses reported in the literature for this indication, DMPS appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of DMPS’s effectiveness for this indication is also reported in the literature.

Various Various Various

Used as an aerosol propellant for topical aerosol formulations in combination with hydrocarbons and other propellants. It is a good solvent and has the unique proerty of high water solubility.

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Used as a solvent and plasticizing agent for film -coatings such as hydroxypropyl methylcellulose, cellulose acetate and cellulose acetate-butyrate mixtures.

Used as a solvent in oral and injectable pharmaceutical formulations, and as a cosolvent to solubilize poorly soluble drugs. Has also been investigated as a vehicle for the parenteral delivery of relatively small peptides. Has been used in topical formulations and has been evaluated as a permeation enhancer for transdermal drug delivery. Solvents have been shown to influence the size and rate of release of norfloxacin from nanopartiles.

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Dinitrochlorobenzene (DNCB), which is well characterized chemically, has been used in the treatment of recurrent melanoma and as a skin sensitizer to estimate immune system competency. It also has been used topically in the treatment of warts. Limited anecdotal evidence of DNCB’s effectiveness for these indications is reported in the literature. DNCB is a highly toxic substance that may be fatal if inhaled, swallowed, or absorbed through skin. High concentrations of DNCB are also extremely destructive to tissues of the mucous membranes and upper respiratory tract, eyes, and skin. At the inaugural meeting of the Pharmacy Compounding Advisory Committee, the nominator of this substance withdrew its a list candidate, but several members of the committee recommended that it still be considered. The Pharmacy Compounding Advisory Committee then voiced concerns about the safety of the substance and expressed a desire for more information about it before making recommendation to the agency. FDA agrees and, therefore, is requesting public input about the historical use, safety, and effectiveness of DNCB, as well as any other information that would be relevant to the agency’s consideration of DNCB for the bulk drugs list. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.(1)

Various Various Various

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API mixed in Acetone, see bibliographies on safety. Topical Solution 0.001% Topical Diphenylcyclopropenone, which is well characterized chemically, has been used for the topical treatment of extensive alopecia aerate. The nomination of this substance was not received by FDA in time to permit a full discussion of it at the October 1998 meeting of the Pharmacy Compounding Advisory Committee. A decision about this substance is therefore being deferred until after FDA has had an opportunity to consult the Pharmacy Compounding Advisory Committee about it at a future meeting. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.

API mixed in Acetone, see bibliographies on safety. Topical Solution 0.005% Topical Diphenylcyclopropenone, which is well characterized chemically, has been used for the topical treatment of extensive alopecia aerate. The nomination of this substance was not received by FDA in time to permit a full discussion of it at the October 1998 meeting of the Pharmacy Compounding Advisory Committee. A decision about this substance is therefore being deferred until after FDA has had an opportunity to consult the Pharmacy Compounding Advisory Committee about it at a future meeting. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.

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API mixed in Acetone, see bibliographies on safety. Topical Solution 0.01% Topical Diphenylcyclopropenone, which is well characterized chemically, has been used for the topical treatment of extensive alopecia aerate. The nomination of this substance was not received by FDA in time to permit a full discussion of it at the October 1998 meeting of the Pharmacy Compounding Advisory Committee. A decision about this substance is therefore being deferred until after FDA has had an opportunity to consult the Pharmacy Compounding Advisory Committee about it at a future meeting. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.

API mixed in Acetone, see bibliographies on safety. Topical Solution 0.025% Topical Diphenylcyclopropenone, which is well characterized chemically, has been used for the topical treatment of extensive alopecia aerate. The nomination of this substance was not received by FDA in time to permit a full discussion of it at the October 1998 meeting of the Pharmacy Compounding Advisory Committee. A decision about this substance is therefore being deferred until after FDA has had an opportunity to consult the Pharmacy Compounding Advisory Committee about it at a future meeting. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.

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API mixed in Acetone, see bibliographies on safety. Topical Solution 0.05% Topical Diphenylcyclopropenone, which is well characterized chemically, has been used for the topical treatment of extensive alopecia aerate. The nomination of this substance was not received by FDA in time to permit a full discussion of it at the October 1998 meeting of the Pharmacy Compounding Advisory Committee. A decision about this substance is therefore being deferred until after FDA has had an opportunity to consult the Pharmacy Compounding Advisory Committee about it at a future meeting. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.

API mixed in Acetone, see bibliographies on safety. Topical Solution 0.1% Topical Diphenylcyclopropenone, which is well characterized chemically, has been used for the topical treatment of extensive alopecia aerate. The nomination of this substance was not received by FDA in time to permit a full discussion of it at the October 1998 meeting of the Pharmacy Compounding Advisory Committee. A decision about this substance is therefore being deferred until after FDA has had an opportunity to consult the Pharmacy Compounding Advisory Committee about it at a future meeting. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.

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API mixed in Acetone, see bibliographies on safety. Topical Solution 0.5% Topical Diphenylcyclopropenone, which is well characterized chemically, has been used for the topical treatment of extensive alopecia aerate. The nomination of this substance was not received by FDA in time to permit a full discussion of it at the October 1998 meeting of the Pharmacy Compounding Advisory Committee. A decision about this substance is therefore being deferred until after FDA has had an opportunity to consult the Pharmacy Compounding Advisory Committee about it at a future meeting. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.

API mixed in Acetone, see bibliographies on safety. Topical Solution 2% Topical Diphenylcyclopropenone, which is well characterized chemically, has been used for the topical treatment of extensive alopecia aerate. The nomination of this substance was not received by FDA in time to permit a full discussion of it at the October 1998 meeting of the Pharmacy Compounding Advisory Committee. A decision about this substance is therefore being deferred until after FDA has had an opportunity to consult the Pharmacy Compounding Advisory Committee about it at a future meeting. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.

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Used in preparations for controlled-release buccal and transdermal patches as a component of the adhesive. Also used in cosmetics, typically sking cleansing preparations, deodorants, lipsticks, and fragrances.

Various Various Various

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Used as a sweetening and antioxidant in oral pharmaceutical proucts and dietary applications.

Various Various Various

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Alky gallates are widely used a antioxidant preservatives in cosmetics, perfumes, foods and pharmaceuticals since the use of propyl gallate in preventing autoxidation of oils was first described in 1943.

Various Various Various

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Various Various Various

Not for food producing animals. Various Various Various

Various Various Various

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Used as a solvent or co-solvent in liquid formulations and co- solvent in emulsions and microemulsions and as a solvent for microcellulose, cellulose acetate, celluose ethers, polyvinyl and other resins. As a flavooring agent in pharmaceutical preparations.

Various Various Various

Used as membranes and backings in laminated transdermal drug delivery systems.

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Various Various Various

Etoposide Injection 20 mg / mL Multiple-Dose vial Oral Suspension 10 mg / mL Oral

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Ferric subsulfate is well characterized chemically. It has been used as a topical hemostatic agent to control bleeding associated with minor surgical procedures, biopsies, and minor gynecological surgery involving the cervix. At doses reported in the literature for this indication, ferric subsulfate appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of ferric subsulfate’s effectiveness for this indication is also reported in the literature. However, because the literature is limited to topical use of this substance, FDA is proposing to include it on the bulk drugs list for topical use only.

Various Various Various

Ferric sulfate hydrate is well characterized chemically. It has been used topically as a hemostatic agent to control bleeding from dermatological and dental procedures. At doses reported in the literature for these indications, ferric sulfate hydrate appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of ferric sulfate hydrate’s effectiveness for this indication is also reported in the literature. However, because the literature is limited to topical use of this substance, FDA is proposing to include it on the bulk drugs list for topical use only.

Various Various Various

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Various Various Various

Drug shortage of fluconazole oral suspension.

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 100 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

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Various Various Various

Injection or API mixed with SWFIrrigation to prepare an oral liquid Oral Liquid 1 mg / mL Oral for patients unable to swallow a solid oral dosage form. Commercial OTC liquids are no an appropriate strength or are mixed with other vitamins.

Various Various Various

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Various Various Various

This combination is used in the direct compression of tablets to improve flowability and compressibility. Used to mask undesirable flabors in components in tablet formulations and create "chewable" tables.

Various Various Various

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Various Various Various

Brilliant Green and Gential Violet mixed to form Bonney & Browning Paint used for fine marking of the face prior to cleft pallet surgery. Various Various Various

Various Various Various

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Various Various Various

Glutamine, the most abundant free amino acid found in the human body, is well characterized chemically. Glutamine is involved in a wide variety of metabolic processes, including regulation of the body’s acid base balance. For years, glutamine has been used in compounding as a supplement in parenteral nutrition regimens in adults. At doses reported in the literature for this use, glutamine appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of glutamine’s effectiveness for this indication is also reported in the literature

Treatment of amino acid deficienty.

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Liquid Liquid

Various Various Various

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Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Emollient and Demeculent

Various Various Various

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Used in oral solid=dosage pharmaceutical formulations as a lubricant. Used to form microsphers used in capsules or compressed to form tablets, pellets, coated beads and biodegradable gels. Also used for taste-masking.

Various Various Various

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Used as a solvant in parenteral products for intravenous or intramuscular injeciton in concentrations up to 50% v/v. Investigated for use as a penetration enhancer and solvent in topical and intranasal formulations. Has also been used at 20% v/v concentration in a rectal formulation.

Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 50 mcg / mL (0.05 mg / mL) Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

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Guaiacol is well characterized chemically. It has been used for decades in compounded products as an expectorant. At doses reported in the literature for this indication, guaiacol appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of guaiacol’s effectiveness for this indication is also reported in the literature.

Various Various Various

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Various Various Various

Absorbant, emulsifying and viscosity-increasing agent in pharmaceutical preparations. A component of other naturally occurring clays. Has been used to modify thixotropic behavior of pharmaceutical dispersions and stabilization of water emulsion bases.

Various Various Various

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Propellant that does not contain any chlorine so therefore considered as an alternative propellant to CFCs in MDIs.

Various Various Various

Antimicrobial preservative in cosmetics and nonparenteral pharmaceutical formulations.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Liquid 4 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Hydrazine sulfate is well characterized chemically and has been used to treat cachexia in cancer patients. The substance, however, is extremely toxic. Multiple exposures to hydrazine sulfate have caused liver and kidney damage, gastrointestinal damage, convulsions, and coma, among other conditions. Hydrazine sulfate is also considered by the International Agency for Research on Cancer to be a potential carcinogen to humans. In at least two clinical studies, hydrazine sulfate was shown to have no effect, or even negative effect, on patients who received it. FDA would like more information about the historical use, safety, and effectiveness of hydrazine sulfate before deciding whether to propose it for inclusion on the bulk drugs list. The Pharmacy Compounding Advisory Committee similarly expressed a desire for more information about hydrazine sulfate before making a recommendation about its status to the agency. FDA is soliciting public input on these and any other issues that are relevant to the agency’s consideration of this substance for the bulk drugs list. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.(1)

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Solution 1:1 Topical or Oral

Various Various Various

Soluton 1:1 Topical or Oral

Various Various Various

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Various Various Various

Used as a buffering agent in injections.

An excipient in a wide range of pharmaceuticals, including oral tablets, suspensions and topical gel preparations. A coating, suspending and viscosity-increasing agent also used as a tablet and capsule binder.

Various Various Various

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Capsule contents emptied and crushed or API mixed with an oral Oral Solution 100 mg / mL Oral vehicle to prepare an oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Various Various Various

Ointment Topical

Various Various Various

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Various Various Various

NF is for Inositol, cis-1,2,3,5-trans-4,6-Cyclohexanehexol; myo- Inositol, CAS 87-89-8 Various Various Various

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Iodoform is well characterized chemically. It has been used for the control of acute epistaxis (nosebleeds) and as a paste for dental root fillings. Iodoform has tested positive in in vitro mutagenicity assays and in an in vitro transformational assay in mammalian cells. However, in 2-year bioassays conducted by the National Toxicology Program, iodoform was found to be noncarcinogenic in rats and mice. At doses reported in the literature for these indications, iodoform appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of iodoform’s effectiveness for these indications is also reported in the literature. However, because the literature is limited to the topical and intradental use of this substance, FDA is proposing to include it on the bulk drugs list for topical and intradental use only.

Contrast dye.

Various Various Various

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Various Various Various

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Various Various Various

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Used as an emollient in topical creams and emulsions. Used in cosmetic bath oils, crems, lotions and lipsticks.

Various Various Various

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Various Various Various

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Various Various Various

A thickener and emulisifier.

Various Various Various

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Various Various Various

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Direct compression excipient to improve compressibility, flowability and disintegration properties in tablets and capsules.

Used in tablets for direct compression.

Used as a diluent for direct compression excipient for chewable tablets, lozenges, and effervescent tablets and controlled-release tablets by direct compression.

Used as a diluent in tablets to improve compressibility and mouthfeel.

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A mixture of amorphous lactose, which is a 1:1 mixture of alpha and beta lactose and O-beta-D-galactopyranosyl-(1-4)-gamma-D- glucopyranose monohydrate

Oral Solution 100 mg / mL Oral

Various Various Various

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Various Various Various

Widely used in pharmaceutical formulations and cosmetics in applications similar to those for lanolin as an emollient, emulsifying agent and ointment base.

Various Various Various

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Various Various Various

Used as a penetration enhancer for topical, transdermal, rectal and intestinal absorption; and buccal delivery. Also used as an emulsifying agent for stabilizing oil-in-water emulsions.

Various Various Various

Treatment of amino acid deficienty.

An alpha-amino acid key to the biochemical urea cycle (ammonia Oral Solution 50 mg / mL Oral excretion).

Treatment of amino acid deficienty.

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Various Various Various

Absorption enhander, emulsifier and solvent, use with Pluronic 20% Gel or 30% Gel to form PLO transderma vehicle.

Various Various Various

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Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Solution 1 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 5 mg / mL and 1.25 mg / Oral liquid for patients unable to swallow a solid oral dosage form. mL There is no commercial oral liquid available in the US.

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Various Various Various

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Topical Gel Various Topical

Various Various Various

Used in topical transdermal and oral formulations as an absorption enhancer; and as an emulsifying agent in topical cosmetic formulatinos and aqueous microemulsions. Has also been a component of nanoparticulate drug cariers.

Various Various Various

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Various Various Various

Oral Solution 10 mg / mL Oral

Oral Suspension 2 gram / 12 mL Oral

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Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 2.5 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Oral Solution 10 mg / mL Oral

Various Various Various

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Various Various Various

Oral Suspension 1:1 Oral

Oral Suspension 1:1:1 Oral

Various Various Various

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Various Various Various

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Various Various Various

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Oral Suspension 500 mg / mL Oral

Various Various Various

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Various Various Various

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Used as a direct compression excipient of tablets that are difficult to compress. Both sugars provide a pleasant taste and favorable mouthfeel for chewable tablets.

Tablet crushed or API mixed with an oral vehicle to prepare an oral Capsules Ear liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Paste 5 mg / 0.5 mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Vehicle used in oral liquids commercially and compounded.

Various Various Various

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Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension Sugar-Free (SF) 50 mg / mL Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

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Metronidazole benzoate, which is well characterized chemically, has been used to treat parasitic diseases such as amoebiasis and giardiasis. The base of this substance (metronidazole) is an FDA- approved drug which has a bitter taste. The benzoate salt apparently renders metronidazole tasteless, however, so metronidazole benzoate is sometimes prescribed instead of the metronidazole base to increase patient compliance, especially in children. Serious adverse reactions associated with the use of metronidazole benzoate have not been commonly reported, and limited anecdotal evidence of its effectiveness is reported in the literature. Although the agency is proposing to include metronidazole benzoate on the bulk drugs list, it is specifically seeking public comment on metronidazole benzoate’s solubility and appropriate dosing, as questions about these issues have been raised in the literature

Capsule contents emptied and crushed or API mixed with an oral Oral Solution 10 mg / mL Oral vehicle to prepare an oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Mixed with non-fat dry milk and SWFIrrigation to prepare a rectal Rectal Enema 1:1 Rectal Enema enema.

Various Various Various

Lubricant, laxative Rectal enema Rectal

Various Various Various

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Various Various Various

An oily liquid used in topical pharmaceutical formulatins and cosmetics as na emulsifying agent with emollient properties.

Various Various Various

Rectal Enema 50% in final volume Rectal Enema

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Various Various Various

Used as an emulsifying agent, tablet and capsule lubricant and penetration enhancer in oral and topical pharmaceutical formulations.

Various Various Various

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Myrrh is a gum resin obtained from the stem of Commiphora molmol and other species of camphora. Myrrh is a mixture of many substances and has not been well characterized chemically. Myrrh has been used in its natural form and as a tincture to treat inflammatory disorders of the mouth and pharynx. The preparation reviewed by FDA is the tincture, which, at doses reported in the literature for those indications, appears to be relatively nontoxic. Serious adverse reactions associated with the use of myrrh gum tincture have not been commonly reported. Limited anecdotal evidence of myrrh gum tincture’s effectiveness for those indications is also reported in the literature. Because the literature is limited to the topical use of this substance, FDA is proposing to include it on the bulk drugs list for topical use only

Various Various Various

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Various Various Various

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A synthetic intense sweetening agent approximately 1500-1800 times sweeter than sucrose and 20 times sweeter than saccharin. A flavor enhancer and sweetening agent.

Various Various Various

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Various Various Various

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Mixed with Molasses for a rectal enema. Powder Straight Powder

Various Various Various

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Various Various Various

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Various Various Various

As alkyl gallate this class has become widely used as an antioxidant preservative in cosmetics, perfumes, foods and pharmaceuticals since the use of propyl gallate in preventing autoxidatio of oils was first described in 1943.

Various Various Various

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Various Various Various

Oral Suspension 6 mg / mL Oral Suspension

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Herbal Various Various Various

Various Various Various

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Various Various Various

Pentylenetetrazole, which is well characterized chemically, was approved by FDA for use in the treatment of senile confusion, depression, psychosis, fatigue, and debilitation, as well as for the relief of dizzy spells, mild behaviorial disorders, irritability, and functional memory disorders in elderly patients. Pentylenetetrazole was formerly marketed in numerous drug products, all of which were removed from the market for lack of effectiveness for these approved indications (see 47FR 19208, May 4, 1982). FDA will consult with the Pharmacy Compounding Advisory Committee at a future meeting about whether to include pentylenetetrazole on the bulk drugs list and will address the effect of its withdrawal from the market at that time. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.(1)

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

This mixture of lanolin alcohols and petrolatum is used as an emollient, ointment base and plasticizing agent.

Various Various Various

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Various Various Various

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Phenindamine tartrate is well characterized chemically. It is an antihistamine that has been used to treat hypersensitivity reactions including urticaria (hives) and rhinitis (nasal inflammation). At doses reported in the literature for this indication, phenindamine tartrate appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Additionally, in developing the over-the-counter monograph for antihistamine drug products, FDA previously established that phenindamine tartrate, under the conditions established in the monograph (including particular labeling and dosage limits), is generally recognized as safe and effective for over-the-counter antihistamine use (see 21CFR 341.12; 57 FR 58356, December 9, 1992). Limited anecdotal evidence of phenindamine tartrate’s effectiveness as an antihistamine is reported in the literature.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Used as an antimicrobial preservative alternative to phenylmercuric acetate or phenylmercuric nitrate. Has been reported to be less irritant than either phenylmercuric acetate or phenylmercuric nitrate.

Various Various Various

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Various Various Various

Phenyltoloxamine dihydrogen citrate, a structural isomer of diphenhydramine, is well characterized chemically. It has been used as an antihistamine. At doses reported in the literature for this indication, phenyltoloxamine dihydrogen citrate appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of phenyltoloxamine dihydrogen citrate’s effectiveness as an antihistamine is reported in the literature

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Various Various Various

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Various Various Various

Used in numerous pharmaceutical formulations where phospholipids form liposomes. They can be anionic, cationic, or neutral in charge. USP monograph is for Lipid Injectable Emulsion. NF is for Egg Phospholipids.

Various Various Various

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Topical Solution 0.5% Topical Solution

For veterinary use only Various Various Various

Various Various Various

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Various Various Various

Piracetam, a derivative of the amino acid gamma-amino butyric acid, is well characterized chemically. Piracetam is believed by some to enhance certain cognitive skills, and has been used to treat Down’s syndrome, dyslexia, and Alzheimer’s disease, among other cognitive disorders. At doses reported in the literature for these indications, piracetam appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of piracetam’s effectiveness for these indications is reported in the literature

Various Various Various

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Various Various Various

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Various Various Various

A biodegradable material used as a coating agent and modified- release agent in implants, injections and oral solid dispersions.

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This chemical and its derivatives are used as controlled-release and enteric coatings; denture, ostomy and transdermal adhesives; toothpastes, mouthwashes and transdermal gels.

Various Various Various

Base B Base A

Base C

Various Various Various

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Various Various Various

Base E

Various Various Various

Sulfurated Potash = Thisulfuric acid, dipotassium salt, mixture with potassium sulfide also called Dipotassium thiosulfate mixture with potassium sulfide CAS 39365-88-3

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Various Various Various

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Injection 2 mEq / mL repackaged into an oral dispensing bottle or Oral Solution 2 mEq / mL Oral API mixed in SWFIrrigation to prepare an oral dosage form for patients on ketogenic diet unable to swallow tablets or capsule commercial dosage forms and who do not need the carbohydrates. There is no commercial liquid dosage form available in the US completely sugar-free.

Injection 2 mEq / mL Intravenous

Various Various Various

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Commercial oral Potassium Iodide Oral Solution, USP 1,000 mg / Oral Solution 30 mg / mL Oral mL commercial product mixed with SWFIrrigation to prepare an oral liquid for small pediatric dosages.

Various Various Various

Oral Solution 3 mMol / mL Oral

API in SWFIrrigation to prepare an oral liquid for patients unable to swallow a solid oral dosage form. The commercial solid dosage forms are not of appropriate strength or volume for pediatric patients. API in SWFIrrigation to prepare an oral liquid for patients unable to swallow a solid oral dosage form. The commercial solid dosage forms are not of appropriate strength or volume for pediatric patients. Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 1.2 mg / mL (base) Oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Injection or API mixed with SWFIrrigation to prepare an oral liquid Oral Solution 5 mg / mL Oral for patients unable to swallow a solid oral dosage form. Commercial OTC liquids are no an appropriate strength or are mixed with other vitamins.

Various Various Various

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Various Various Various

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Various Various Various

Has been shown to be a better solubilizer than glycerin, propylene glycol, or ethanol. As a solvent in parenteral, oral and topical applications, and a penetration enhancer.

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Various Various Various

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A trisaccharide carbohydrate used as a bulking and stabilizing agent. Also used as a crystallization inhibior in sucrose solutions.

Various Various Various

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Various Various Various

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Various Various Various

Capsule contents emptied and crushed or API mixed with an oral Oral Suspension 50 mg / mL Oral vehicle to prepare an oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

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Oral Suspension 20 mg / mL Oral

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

A colloidal component of magnesium aluminum silicates useful as a fomulation component in semisolid cosmetic and health care products. A naturally occurring clay it is used in pharmaceutical formulations as an adsorbent, viscosity-increasing agent, suspending agent and as an oil-in-water emulsifying.

Various Various Various

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Injection or API mixed with SWFIrrigation to prepare an oral liquid Oral Solution 5 mcg / mL Oral for patients unable to swallow a solid oral dosage form. Commercial OTC liquids are no an appropriate strength or are mixed with other minerals.

Various Various Various

Dietary Supplement.

Various Various Various

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Various Various Various

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Various Various Various

Rectal Suspension Rectal Suspension

Various Various Various

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Mild silver protein is well characterized chemically. It has been used to treat conjunctivitis and by ophthalmologists as a preoperative chemical preparation of the eye. At doses reported in the literature for these indications, mild silver protein appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. When mild silver protein is administered internally, however, it can cause serious untoward side effects, including agrarian, permanent ashen-gray discoloration of the skin, conjunctiva, and internal organs (see 61 FR 53685, October 15,1996). At this time, FDA is deferring decision on this substance because questions were raised at the inaugural meeting of the Pharmacy Compounding Advisory Committee about its efficacy. FDA is soliciting public input on this issue and any other issues that are relevant to the agency’s consideration of mild silver protein for the bulk drugs list. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.(1)

Various Various Various

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Various Various Various

Thickening/emulsifying agent; Biotechnology-Derived Articles- Polyacrylamide Gel Electrophoresis <1056> Commercial oral liquid dosage form mixed with a topical vehicle for Topical Cream 0.5 mg / mL Topical Cream patients who need a topical dosage form who are unable to tolerate a larger oral dosage form due to toxicity.

Various Various Various

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Aspartate is talked about in USP General Chapter <1052> Biotechnology-Derived Articles - Amino Acid Analysis

API in SWFIrrigation to prepare an oral liquid for patients unable to Oral Solution 50 mg / mL Oral Solution swallow a solid oral dosage form.

Various Various Various

API and SWFIrrigation to prepare an oral liquid dosage form for Injection 2.5 mEq / mL Intravenous patients unable to swallow a solid oral dosage form. Management of metabolic acidosis; antacid; alkalinization of urine and stabilization of acid base status.

API and SWFIrrigation to prepare an oral liquid dosage form for Oral Solution 1 mEq / mL Oral Solution patients unable to swallow a solid oral dosage form. Management of metabolic acidosis; antacid; alkalinization of urine and stabilization of acid base status.

Various Various Various

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Various Various Various

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Various Various Various

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Sodium butyrate is a short chain fatty acid that is well characterized chemically. It has been used rectally in an enema formulation to treat several inflammatory bowel conditions, including ulcerative colitis and diversion colitis. At doses reported in the literature for these indications, sodium butyrate appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of sodium butyrate’s effectiveness for these indications is also reported in the literature. However, because the literature is limited to the use of sodium butyrate rectally in an enema formulation, FDA is proposing to include it on the bulk drugs list for use in this dosage form and route of administration only.

Various Various Various

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Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Solution, or injectable 2.5 mEq / mL Oral Solution liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.Crystals dissolvedin Sterile Water for Injection to prepare an injectable due to drug shortage.

API to prepare injectable solutions that have been on short supply. Injection 0.9% 14.6% and 23.6% Injection

Various Various Various

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Various Various Various

Used as an intense sweetening agent in pharmaceuticals formulations, foods, beverages, and table-top sweeteners. It enhances flavor systems and can be used to mask some unpleasant tastes.

Various Various Various

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Various Various Various

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Various Various Various

The predominant form of hyaluronic acid at physiological pH. The terms hyaluronic acid and sodium hyaluronate are used interchangeably. Used for drugs administered to the eye.

Various Various Various

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Sodium Nitrate API in Sterile Water for Irrigation for use in cystic Topical Solution 1% Topical fibrosis diagnosis.

Various Various Various

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Injection has been used orally for years due to no commercial Oral Solution 3 mMole / mL Oral Solution liquid oral dosage form. Injection shortage forced the mixture using APIs. Contains 3 mMol / mL Phosphate + 4 mEq / mL Sodium. *Each mL of the commercial injectable formulation contains 142 mg Sodium Phosphate Dibasic Anhydrous and 276 mg Sodium Phosphate Monobasic Monohydrate. For each mL this formula uses 240 mg Sodium Phosphate Monobasic Anhydrous for 276 mg Sodium Phosphate Monobasic Monohydrate.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 5 mg / mL Oral Suspension liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Squaric acid dibutyl ester, which is well characterized chemically, is a contact sensitizer that has been used as a topical treatment for alopecia aerate and warts. The nomination of this substance was not received by FDA in time to permit full discussion of it at the October1998 meeting of the Pharmacy Compounding Advisory Committee. A decision about this substance is therefore being deferred until after FDA has had an opportunity to consult the Pharmacy Compounding Advisory Committee about it at a future meeting. C. Nominated Drug Substances Still Under Consideration for the Bulk Drugs List The following 10 drug substances were nominated for inclusion on the proposed bulk drugs list. However, for the reasons described in section III.C of this document, they are still under review by the agency.(1)

Various Various Various

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Various Various Various

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Tablet crushed or API mixed with an oral vehicle to prepare an oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Sweetener.

Various Various Various

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Various Various Various

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 100 mg / mL Oral Suspension liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

An oligosaccharide derived from starch it enhances the solubility of peptides, proteins and small organic molecules in water. Used primarily in parenteral drug products it can also be used in oral solid and liquid dosage forms.

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Various Various Various

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Various Various Various

Fatty acid suppository base suitable for rectal and vaginal use. Also talked about in USP <1151> Pharmaceutical Dosage Forms

Capsule contents emptied and crushed or API mixed with an oral Oral Suspension 0.5 mg / mL Oral vehicle to prepare an oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

Tamsulocin 0.4 mg capsule opened and divided into 0.2 mg Capsules 0.2 mg Capsules capsules or API packaged into 0.2 mg capsules. API used to mix an oral liquid.

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Various Various Various

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Various Various Various

Taurine, an amino acid with several important physiological functions, including a role in bile acid conjugation, is well characterized chemically. It has been used for years in compounding as a component in parenteral nutrition solutions for infants and adult patients. At doses reported in the literature for this use, taurine appears to be relatively nontoxic, andserious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of taurine’s effectiveness for this indication is also reported in the literature.

Used in nail fungus treatments combined with other antifungals.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Capsules contents emptied and crushed or API is mixed with Oral Suspension 10 mg / mL Oral Povidone K-30 Powder, citric acid anhydrous powder, SWFIrrigation and an oral vehicle to prepare an oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Various Various Various

A hydroflurocarbon used in metered-dose inhalers (MDIs).

Various Various Various

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

A naturally occurring intense sweetening agent approximately 2000-3000 times as sweet as sucrose with a licorice-like aftertaste. Used extensively in food as a sweeting agent and flavor enhancer and has potential for use in pharmaceutical applications such as oral suspensions.

Various Various Various

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Various Various Various

Injection with Sterile Water for Injection to prepare an oral liquid Oral Solution 20 mg / mL Oral dosage form for patients unable to swallow a solid oral dosage form. Commercial oral dosage liquid forms are OTC and mixed with many other vitamins unneccessary for a patient who only needs thiamine.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Thymol iodide is well characterize chemically. It has been used as a Topical topical agent for its absorbent, protective, and antimicrobial properties. At doses reported in the literature for these indications, thyme iodide appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of thymol iodide’s effectiveness for these indications is also reported in the literature. FDA notes, however, that it was able to identify only two relevant articles concerning this substance. Because the literature is limited to the topical use of thymol iodide, FDA is proposing to include it on the bulk drugs list for topical use only.

Various Various Various

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Tinidazole is a chemically well-characterized derivative of 5- Oral nitromidazole. It has been used, often in conjunction with diloxanide furoate, which also appears on this proposed list, to treat parasitic diseases such as amoebiasis and giardiasis. At doses reported in the literature for these indications, tinidazole appears to be relatively nontoxic, and serious adverse reactions associated with its use have not been commonly reported. Limited anecdotal evidence of tinidazole’s effectiveness for these indications is also reported in the literature.

Various Various Various

Thickening/emulsifying agent Various Various Various

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Various Various Various

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Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 10 mg / mL Oral Suspension liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Used in pharmaceutical preparations as a neutral carrier, absorption promoter, and solubilizer for active drugs. Used in the oily phase to prepare water-in-oil-in-water emulsions for incorporating water-soluble drugs acting as a vehicle for topical creams adn lotions and cosmetic preparations.

API in SWFIrrigation for use topically by plastic surgeons and Topical Solution 50% and 90% Topical dermatologists for facial peels and warts.

Various Various Various

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Various Various Various

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Various Various Various

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Used as a solubilizer and solvent in injectable preparations such as sustained-release cytarabine. In personal care products it is used as a skin-conditioning and viscosity-controlling agent.

Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

For veterinary use only.

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Various Various Various

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Various Various Various

API in SWFIrrigation to prepare an oral liquid for patients unable to Oral Solution 300 mg / mL (30%) Oral swallow a solid oral dosage form.There was an injectable Urea available in the US market but has been discontinued by the manufacturer.

API in Sodium Chloride for Irrigation 0.9% for bladder irrigation. Bladder Solution 20% Bladder There is no commercial product available. There was an injectable Urea available in the US market but has been discontinued by the manufacturer.

Various Various Various

Capsule contents emptied and crushed or API mixed with an oral Oral Suspension 50 mg / mL Oral Suspension vehicle to prepare an oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

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Various Various Various

Caplets crushed or API mixed in an oral vehicle to prepare an oral Oral Suspension 50 mg / mL Oral Suspension liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Treatment of amino acid deficiency Various Various Various

In Dietary Supplements: Minerals Capsules and several other dietary supplements in USP. Injection or API to prepare an oral liquid dosage form for patients Oral Solution 50 mg / mL Oral Solution unable to swallow a solid oral dosage form. There was a commercial oral liquid vancomycin on the market for years that was discontinued by the manufacturer.

Various Various Various

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Tablet crushed or API mixed with an oral vehicle to prepare an oral Oral Suspension 50 mg / mL Oral Suspension liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Various Various Various

Emulsifying, solubilizing and stiffening agent used in cosmetic and topical pharmaceutical formulations. Added to fatty or paraffin bases helps facilitate the production of oil-in-water emulsions.

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

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Various Various Various

Injection There is no single zinc sulfate oral liquid available in the Oral Solution and injection 1 mg / mL Oral and IV US for patients who are unable to swallow a solid oral dosage form. Zinc sulfate injection has been in short supply, the API is needed to prepare an oral liquid or an injection. APIs with different waters of hydration may be used dependent on availability.

Various Various Various

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Various Various Various

Capsule contents emptied and crushed or API mixed with an oral Oral Suspension 10 mg / mL Oral Suspension vehicle to prepare an oral liquid for patients unable to swallow a solid oral dosage form. There is no commercial oral liquid available in the US.

Various Various Various

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Various Various Various

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Final Compounded Formulation Final Compounded Formulation Clinical Final Compounded Formulation Final Compounded Formulation Stability Data of the Final Rationale and Use Stability Reference Stability Reference Preparation

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Distal intestinal obstruction syndrome (previously known Allen LV Jr, Erickson MAIII. Stability of Trissel LA. Trissel's Stability of Compounded as "meconium ileus or its equivalent"). acetazolamide, allopurinol, azathioprine, Formulations, 4th ed. Washinton, DC: American clonzaepam, and flucytosine in Pharmacists Association; 2009. extemporaneously compounded oral liquids. Am J Health Syst Pharm 1996; 53(16): 1944- 1949.

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Antidote for acetaminophen toxicity; prevention of Fohl AL, Johnson CE, Cobe MP. Stability of Siden R, Johnson CE. Stability of a flavored Trissel LA. Trissel's Stability of Compounded radiocontrast-induced renal dysfunction; distal intestinal extemporaneously prepared acetylcysteine 1% formulation of acetylcysteine for oral Formulations. 4th ed. 2009. American Pharmacists obstruction (meconium ileus). and 10% solutions for treatment of meconium administration. Amer J Health-Syst Pharm 2008: Association, Washington, DC. ileus. Amer J Health-Syst Pharm 2011: 68(1); 65(6); 558-61. 69-72.

Antidote for acetaminophen toxicity; prevention of Kiser TH, Oldland AR, Fish DN. Stability of Trissel LA. Trissel's Stability of Compounded radiocontrast-induced renal dysfunction; distal intestinal acetylcysteine solution repackaged in oral Formulations. 4th ed. 2009. American Pharmacists obstruction (meconium ileus). syringes and associated cost savings. Am J Association, Washington, DC. Health-Syst Pharm 2007: 64(7); 762-6.

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Treatment of attacks of gouty arthritis and nephropathy; Allen LV, Erickson MA. Stability of Trissel LA. Trissel's Stability of Compounded also used in treatment of secondary hyperurecemia which acetazolamide, allopurinol, azathioprine, Formulations. 4th ed. 2009. American Pharmacists may occur during treatment of tumors or leukemia; clonzaepam, and flucytosine in Association, Washington, DC. prevention of recurrent calcium oxide calculi. extemporaneously compounded oral liquids. Am J Health Syst Pharm 1996 Aug 15; 53(16): 1944-9.

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Management of edema associated with CHF, hepatic Fawcett JP, Woods DJ, Ferry DG, et al. Stability Nahata MC, Pai VB. Pediatric Formulations 6th ed. Trissel LA. Trissel's Stability of Compounded cirrhosis, and hyprealdosteronism, hypretension, primary of Amiloride Hydrochloride Oral Liquids Cincinnati, OH: Harvey Whitney Books Co, 2011. Formulations. 4th ed. 2009. American Pharmacists hyperaldosteronism, and hypokalema induced by kaliuretic Prepared From Tablets and Powder. Aust J Association, Washington, DC. diuretics. Hosp Pharm 1995; 25(1): 19-23.

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Management of life-threatening recurrent ventricular Nahata MC. Stability of amiodarone in an oral Nahata MC, Hipple TF. Pediatric Drug arrhythmias [recurent ventricular fibrillation (VF) or suspension stored under refrigeration and at Formulations. Harvey Whitney Books: Cincinnati, recurrent hemodynamically unstable ventricular room temperature. Annals of Pharmacother OH. 1997. 4th Edition. tachycardia (VT)] unresponsive to other therapy or in 1997: 31(July/Aug); 851-852. patients intolerant to other therapy.

Hypertension; chronic stable angina, vasospastic Nahata MC, Morosco RS, Hipple TF. Stability of Trissel LA. Trissel's Stability of Compounded (Prinzmetal's) angina; angiographically documented CAD amlodipine besylate in two liquid dosage Formulations. 4th ed. 2009. American Pharmacists [to decrease risk of hospitalization (due to angina) and formulations. J Am Pharm Assoc 1999: 375-7. Association, Washington, DC. coronary revascularization procedure].

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Diuretic or systemic and urinary acidifying agent; Up to 30 days based on USP , - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 30 days, whichever is earlier.

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Prevention of acute and delayed nausea and vomiting Dupuis LL, Lingertat-Walsh K, Walker SE. Trissel LA. Trissel's 2 Clinical Pharmaceutics associated with initial and repeat courses of moderate and Stability fo an extemporaneous oral liquid Database at www.CompoundingToday.com. highly emetogenic cancer chemotherapy. aprepitant formulation. Support Care Cancer Copyright 203-2011. Updated September 2011, 2009; 17: 701-706. Accessed 11-28-2011.

Prevention of necrotizing enterocolitis; pituitary function Up to 14 days based on USP <795> - The BUD test (stimulant for release of growth hormone); is not later than the time remaining until the management of severe, uncompensated, metabolic earliest expiration date of any Active alkalosis after optimizing therapy with sodium or Pharmaceutical Ingredient (API) or 14 days, potassium chloride supplements; treatment for urea cycle whichever is earlier. disorders.

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Hypertension, supraventricular and ventricular Patel D, Doshi DH, Desai A. Short-term Nahata MC, Pai VB. Pediatric Formulations 6th ed. arrhythmias. stability of atenolol in oral liquid formulations. Cincinnati, OH: Harvey Whitney Books Co, 2011. Int J Pharm Compound 1997; 1(5): 437-9.

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Adjunct with other agents in prevention of solid organ Allen LV, Erickson MA. Stability of Trissel LA. Trissel's Stability of Compounded tansplant rejection; used as an immunosuppresant in a acetazolamide, allopurinol, azathioprine, Formulations. 4th ed. 2009. American Pharmacists variety of autoimmune diseases such as SLE,, severe clonzaepam, and flucytosine in Association, Washington, DC. rheumatoid arthritis unresponsive to other agents, and extemporaneously compounded oral liquids. nephrotic syndrome; steroid-sparing agent for Am J Health Syst Pharm 1996 Aug 15; 53(16): corticosteroid-dependent Crohn's disease and ulcerative 1944-9. colitis.

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Cerebral spasticity and reversible spasticity associated with Allen LV Jr, Erickson MAIII. Stability of Trissel LA. Trissel's Stability of Compounded multiple sclerosis or spinal cord lesions. baclofen, captopril, diltiazem hydrochloride, Formulations. 4th ed. 2009. American Pharmacists dipyridamole, and flecainide acetate in Association, Washington, DC. extemporaneously comopunded oral liquids. Am J Health-Syst Pharm 1996; 53: 2179-2184.

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Graft versus host disease (GVHD) and idiopathic Micromedex, Rai et al 1997. lymphocytic enterocolitis.

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Nonobstructive urinary retention and retention due to Schlatter JL, Saulnier JL. Bethanechol Chloride neurogenic bladder; gastroesophageal reflux. Oral Solutions: Stability and Use in Infants. Ann Pharmacother Mar 1997; 31(3):294-6.

Nonobstructive urinary retention and retention due to Allen LV Jr. Bethanechol 5 mg / mL Oral Liquid. neurogenic bladder; gastroesophageal reflux. Inj J Pharmaceutical Compounding 2005; 9(6): 473.

Treatment of primary biotinidase deficiency; nutritional Up to 14 days based on USP <795> - The BUD biotin deficiency; component of the vitamin B complex. is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical

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Gentian Violet, is used as a tretemtn of cutaneous or Up to 180 days based on USP <795> - The Brilliant Green C.I. 42040. mucocutaneous infections caused by Candida albicans and BUD is not later than the time remaining until http://www.polysciences.com/Core/Display.aspx? othe rsuperficial skin infections refractory to topical the earliest expiration date of any Active pageId=98&categoryId=50&productId=2825 nystatin, clotrimazole, miconazole, or econazole. Brillient Pharmaceutical Ingredient (API) or product, or Accessed 12-28-2011. Green, Certified is used as a bacteriostatic agent for the 180 days, whichever is earlier. selective enrichment and enumeration of E. coli and ohter fecal coliform organisms in water, milk and food. The mixture of both is used for cleft pallet marking using a syringe with needle for fine lines.

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Graft versus host disease (GVHD). Budesonide Inhalation Suspension 0.5 mg / 2 mL. [Package Insert]. Teva Pharmaceuticals, Sellersville, PA. Revised 9/2011

Management of anxiety disorders.

Chronic myelogenous leukemia (CML); component of Partin JM, Poust RI, Cox FO, et al. Stability of Allen LV. Busulfan Oral Suspension. US Pharmacist Trissel LA. Trissel's Stability of Compounded marrow-ablative conditioning regimen prior to bone busulfan in suspension. Pharm Res 1988; 5: S- 1990; 15: 94-5. Formulations. American Pharmaceutical marrow transplantation (BMT) for refractory leukemias, 74. Assocation: Washington, DC 1996. lymphomas, and pediatric solid tumors.

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Treatment of warts and molluscum contagiosum. Up to 180 days based on USP <795> - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 180 days, whichever is earlier.

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Management of hypertension, congestive heart failure Nahanta MC, Hipple TF. Stability of captopril in Trissel LA. Trissel's Stability of Compounded (CHF); in post-MI patients, improves survival in clinically liquid containing ascorbic acid or sodium Formulations. 4th ed. 2009. American Pharmacists stable patients with left-ventricular dysfunction. ascorbate. Am J Hosp Pharm 1994; 51: 1707- Association, Washington, DC. 8.

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Treatment of mild to severe chronic heart failure of Yamreudeewong W, Dolence EK, Pahl D. Buotempo F, Bernabeu E, Glisoni RJ, et al. Trissel LA. Trissel's Stability of Compounded cardiomyopathic or ischemic origin (usually in addition to Stability of two extemporaneously prepared Carvedilol stability in paediatric oral liquid Formulations. 4th ed. 2009. American Pharmacists standard therapy); management of hypertension, alone or oral metoprolol and carvedilol liquids. Hosp formulations. Farmacia Hospitalaria 2010; 34(2). Association, Washington, DC. in combination with other agents; reduction of Pharm 2006:254-9. cardiovascular mortality in patients with left ventricular dysfunction following mycardiol infarction (MI).

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Treatment of serious infections due to organisms resistant Martindale: The Extra Pharmacopeia-online. to other less toxic antibiotics or when its penetrability into 1995. the site of infection is clincially superior to other antibiotics to which the organism is sensitive; useful in infections caused by Bacteroides, H. influenza, Neisseria meningitis, S. pneumoniae, Salmonella, and Rickettsia; active against many vancomycin-resistant enterococci.

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Suppression of chemoprophylaxis of malaria in chloroquine- Mirochnick M, Barnett E, Clark DF, et al. Trissel LA. Trissel's Stability of Compounded sensitive areas; treatment of uncomplicated acute attacks Stability of chloroquine in an Formulations, 4th ed. Wshington, DC: American of malaria due to susceptible plasmodium species, except extemporaneously prepared suspension Pharmacists Association; 2009. chloroquine-resistent plasmodium falciparum; stored at three temperatures. The Pediatric extraintestinal amebiasis; has been used for treatment of Infectious Disease Journal. 1994; 13(9): 827-8. rheumatoid arthritis, discoid lupus erythematosus, scleroderma, pemphigus.

Management of mild to moderate hypretension; edema Woods DJ. Formulation in pharmacy practice. United States Pharmacopeial Convention, Inc. Trissel LA. Trissel's Stability of Compounded associated with congestive heart failure (CHF), pregnancy, Dunedin, New Zealand: Health-Care Otago; United States Pharmacopeia - National Formulary. Formulations, 4th ed. Wshington, DC: American or nephrotic syndrome. 1993. Rockville, MD: US Pharmacopeial Convention, Inc.; Pharmacists Association; 2009. Current chapters for pharmacy compounding <795>, and <1163>.

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Up to 14 days based on USP <795> - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical

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Topical skin protectant, astringent, anti-fungal, and bile salt Up to 90 days based on USP <795> - The BUD binding agent for skin breakdown secondary to diarrhea is not later than the time remaining until the and hematochezia. earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 90 days, whichever is earlier.

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Alone or as an adjunct in the treatment of absence (petit Allen LV. Clonazepam suspension. US Allen LV, Erickson MA. Stability of acetazolamide, Trissel LA. Trissel's Stability of Compounded mal), petit mal variant (Lennox-Gastaut), infantile spasms, Pharmacist 1995 Feb; 84-85. allopurinoll, azathioprine, clonazepam, and Formulations 4th ed. Washington, DC: American akinetic, and myoclonic seizures; panic disorder with or flucytosine in extemporaneously compounded oral Pharmacists Association; 2009. without agoraphobia. liquids. Am J Health Syst Pharm. 1996 Aug 15; 53(16): 1944-19.

Management of hypertension; aid in the diagnosis of Levinson ML, Johnson CE. Stability of an Trissel LA. Trissel's Stability of Compounded pheochromocytoma and growth hormone deficiency; used extemporaneously compounded clonidine Formulations 4th ed. Washington, DC: American for heroin withdrawal and smoking cessation therapy in hydrochloride oral liquid. Am J Hosp Pharm Pharmacists Association; 2009. adults; alternate agent for the treatment of attention- 1992; 49(1): 122-5. deficit / hyperactivity disorder (ADHD); adjunct in the treatment of neuropathic pain; epidural form is used in combination with opiates for relief of severe pain in cancer patients whose pain was not relieved by opiates alone.

Reduction of artherothrombotic events (MI, stroke, and Skillman KL, Caruthers RL, Johnson CE. Trissel LA. Trissel's Stability of Compounded vascular deaths) in patients with recent myocardial Stability of an extemporaneously prepared Formulations 4th ed. Washington, DC: American infarction (MI), stroke, or established peripheral arterial clopidogrel oral suspension. Am J Health-Syst Pharmacists Association; 2009. disease; reduction of artherothrombotic events in patients Pharm 2010; 67: 559-61. with non -ST-segment elevation acute coronary syndrome (unstable angina and non-Q-wave MI) managed medically and through percutaneous coronary intervention (with or without stent) or CABG; decrease in death rate and arthero- events in patients with ST-segment elevation acute MI (STEMI).

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Two types of collodion are flexible and non-flexible; both Up to 180 days based on USP <795> - The are a flammable, syrupy solution of pyroxylin (a.k.a. BUD is not later than the time remaining until "nitrocellulose", "cellulose nitrate", "flash paper", and "gun the earliest expiration date of any Active cotton") in ether and alcohol. The flexible type is often Pharmaceut used as a surgical dressing or to hold dressings in place, glue electordes to the heat for electroencephalography. When painted on the skin, collodion dries to form a flexible cellulose film. Non-flexible collodion is used in theatrical makeup for various effects, such as simulating old-age wrinkles or scars. When applied to the skin, it shrinks as the solvent (usually ether or alcohol) evaporates, causing wrinkles and is used to simulate old age, or scars. Collodion is used in the cleaning of optics such as telescope mirrors. The collodion is applied to the surface of the optic, usually in two or more layers. Sometimes a piece of thin cloth is applied between the layers, to hold the collodion together for easy removal. After the collodion dries and forms a solid sheet covering the optic, it is carefully peeled away taking contamination with it; it is a pure type of pyroxylin used to embed specimens which will be examined under a microscope.

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Treatment of Hodgkin's lymphoma, non-Hodgkin's Kennedy R, Groepper D, Taghen M, et al. lymphoma (including Burkitt's lymphoma), chronic Stability of cyclophosphamide in lymphocytic leukemia (CLL), chronic myelocytic leukemia extemporaneous oral suspensions. Ann (CML), acute myelocytic leukemia (AML), acute Pharmacother 2010: 295-301 lymphocytic leukemia (ALL), mycosis fungoides, multiple myeloma, neuroblasoma, retinoblastoma, breast cancer, ovarian adenocarcinoma, Ewing's sarcoma, rhabdomyosarcoma, Wilm's tumor, ovarian germ cell tumors, small cell lung cancer, testicular cancer, pheochromocytoma, bone marrow transplantation conditioning regimen.

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Treatment of spasticity associated with upper motor Fawcett JP, Stark G, Tacher IG, Woods DJ. Trissel LA. Trissel's Stability of Compounded neuron disorders such as spinal cord injury, stroke, cerebral Stability of dantrolene oral suspension Formulations 4th ed. Washington, DC: American palsy, or multiple sclerosis; tretmant of malignant prepared from capsules J Clin Pharm Ther Pharmacists Association; 2009. hyperthermia. 1994; 19: 349-53. Treatment of leprosy due to susceptible strains of M. Nahata MC, Morosco RS, Trowbridge JM. Nahata MC, Pai VB. Pediatric Drug Formulations. Trissel LA. Trissel's Stability of Compounded leprae; treatment of dermatitis herpeliformis; prophylaxis Stability of dapsone in two oral liquid dosage 6th ed. Cincinnati, OH. Harvey Whitney Books Co.; Formulations, 4th ed. Washington, DC: American against Pneumocystis jiroveci pneumonia (PCP) and forms. Ann Pharmacother 2000; 34: 848-850. 2011. Pharmacists Association; 2009. toxoplasmic encephalitis in patients who cannot tolerate sulfamethoxazole and trimethoprim or aerosolized pentamidine; topcial treament of acne vulgaris.

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Swallowing techniques. Up to 180 days per USP <795> _ The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or 6 months, whichever is earlier.

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Drug shortages of FDA approved products.

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Allergic contact sensitizer, topical immunotherapy for Up to 91 days based on USP <795> - The BUD allopecia areata; recalcitrant and plantar warts. is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 6 months, whichever is earlier.

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Maintain patency after surgical grafting procedures Allen LV, Erickson MA. Stability of baclofen, Trissel LA. Trissel's Stability of Compounded including coronary artery bypass; with warfarin to decrease captopril, diltiazem hydrochloride, Formulations, 4th ed. Washington, DC: American thrombosis in patients after artificial heart valve dipyridamole and flecainamide acetate in Pharmacists Association; 2009. replacement, for chronic management of angina pectoris, extemporaneously compounded oral liquids. with aspirin to prevent coronary artery thrombosis; in Am J Health-Syst Pharm. 1996 Sep 15; 15: combination with aspirin or warfarin to prevent other 2179-2184. thromboembolic disorders; may also be given 2 days prior to openheart surgery to prevent platelet activation by extracorporeal bypass pump; diagnositc agent intravenous (stress test) for coronary artery disease.

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Management of mild to severe hypertension, congestive Allen LV Jr, Erickson MA. Stability of Trissel LA. Trissel's Stability of Compounded heart failure (CHF), and asymptomatic left ventricular alprazolam, chloroquine phosphate, cisapride, Formulations, 4th ed. Washington, DC: American dysfunction; has also been used to treat proteinuria in enalapril maleate, and hydralazine Pharmacists Association; 2009. steroid-resistant nephrotic syndrome patients. hydrochloride in extemporaneously compounded oral liquids. Am J Health-Syst Pharm 1998; 55: 1804-9.

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Treatment of testicular and lung carcinomas, malignant McLeod HL, Relling MV. Stability of etoposide Trissel LA. Trissel's Stability of Compounded lymphoma, Hodgkin's disease, leukemias (ALL, ANLL, AML), solution for oral use. Am J Hosp Pharm 1992; Formulations, 4th ed. Washington, DC: American neuroblastoma, Ewing's sarcoma, rhabdomyosarcoma, 49: 2784-5. Pharmacists Association; 2009. osteosarcoma, Wilm's tumor, brain tumors; conditioning regimen with hematopoietic stem cell support.

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Prevention and suppression of documented life- Allen LV, Erickson MA. Stability of baclofen, Trissel LA. Trissel's Stability of Compounded threatening ventricular arrhythmias (ie, sustained captopril, diltiazem hydrochloride, Formulations, 4th ed. Washington, DC: American ventricular tachycardia); prevention of systomatic, dipyridamole, and flecainide acetate in Pharmacists Association; 2009. disabling supraventricular tachycardias in patients without extemporaneously compounded oral liquids structural heart disease. Am J Health Syst Phar 1996; 53: 2179-84.

In combination with amphotericin B in the treatment of Up to 14 days based on USP <795> - The BUD Wintermeyer SM, Nahata MC. Stability of Trissel LA. Trissel's Stability of Compounded serious Candidal or Cryptococcal pulmonary or urinary is not later than the time remaining until the Flucytosine in an Extemporaneously Compounded Formulations, 4th ed. Washington, DC: American tract infections, sepsis, meningitis, or endocarditis earliest expiration date of any Active Oral Liquid. Am J Health-Syst Pharm 1996; 53: 407- Pharmacists Association; 2009. (resistance emerges if flucytosine is used as a single agent); Pharmaceutical Ingredient (API) or 14 days, 9. used in combination with another antifungal agent for whichever is earlier. treatment of chromomycosis and aspergillosis.

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Treatment of Addison's disease; partial replacement Up to 14 days based on USP <795> - The BUD therapy for adrenal insufficiency, treatment of salt-losing is not later than the time remaining until the forms of congenital adrenogenital syndrome; has been earliest expiration date of any Active used in conjunction with an increased sodium intake for Pharmaceutical Ingredient (API) or 14 days, the treatment of idiopathic orthostatic hypotension. whichever is earlier.

Treatment of megaloblastic and macrocytic anemias due to Smith SG. A folic acid solution for oral use. Woods D. Extemporaneous formulation in Trissel LA. Trissel's Stability of Compounded folate deficiency; dietary supplement to prevent neural Pharm J 1976; 216: 109. pharmacy practice. Part 1: Folic acid oral solution. Formulations, 4th ed. Washington, DC: American tube defects during pregnancy. NZ Pharm 1993; 13: 34. Pharmacists Association; 2009.

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Glycerin, High Osmolarity Enema compound for Up to 180 days based on USP - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 180 days, whichever is earlier.

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Prophylaxis and treatment of chemotherapy and radiation- Nahata MC, Morosco RS, Hipple TF. Stability of related nausea and emesis, and postoperative nausea and Granisetron Hydrochloride in Two Oral Trissel LA. Trissel's Stability of Compounded vomiting. Suspension. Am J Health-Syst Pharm 1998; Formulations, 4th ed. Washington, DC: American 55(23): 2511-3. Pharmacists Association; 2009.

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Management of mild to moderate severe hypertension; Allen LV, Erickson MA. Stability of alprazolam, Allen LV, Erickson M. Stability of Trissel LA. Trissel's Stability of Compounded congestive heart failure, hypertension secondary to pre- chloroquine phosphate, cisapride, enalapril Extemporaneously Prepared Pediatric Formulations, 4th ed. Washington, DC: American eclampsia / eclampsia, primary pulmonary hypertension. maleate, and hydralazine hydrochloride in Formulations Using Ora-Plus with Ora-Sweet and Pharmacists Association; 2009. extemporaneously compounded-oral liquids. Ora-Sweet SF - Part III. Secundum Artem 1999; Am J Health-Syst Pharm 1998, 55(18): 1915- 6(2). Accessed www.paddocklabs.com 1-30-2012. 20.

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Management of adrenocortical insufficiency; relief of Chong G, Decarie D, Ensom MHH. Stability of Trissel LA. Trissel's Stability of Compounded inflammation and pruritis associated with corticosteroid hydrocortisone in extemporaneously Formulations, 4th ed. Washington, DC: American responsive dermatoses; adjunctive treatment of ulcerative compounded supensions. J Inform Pharmacists Association; 2009. colitis; septic shock. Pharmacother 2003; (13): 100-110.

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Cleanse wounds, suppurating ulcers, and local infections; Up to 14 days based on USP <795> - The BUD used in the treatment of inflammatory conditions of the is not later than the time remaining until the external auditory canal and as a mouthwash or gargle, earliest expiration date of any Active hydrogen peroxide 30% concentration has been used as a Pharmaceutical Ingredient (API) or product, or hair bleach and as a tooth bleaching agent. 14 days, whichever is earlier.

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Suppression or treatment of malaria caused by susceptible Pesko LJ. Compounding: Hydroxychloroquine. Trissel LA. Trissel's Stability of Compounded P. vivax, P. ovale, P. malariae, and some strains of P. Am Druggist 199; 207: 57. Formulations. 4th ed. 2009. American Pharmacists falciparum (not effective against chloroquine resistant Association, Washington, DC. strains of P. falciparum; not active against pre-erythrocytic or exoerthyrocytic tissue stages of Plamodium); treatment of systemic lupus erythematosus (SLE) and active or chronic rheumatoid arthritis.

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Treatment of chronic myelocytic leukemia (CML), Heeney MM, Wharton MR, Howard TA, et al. Trissel LA. Trissel's Stability of Compounded melanoma, and relapsed or refractory ovarian carcinoma; Chemical and functional analysis of Formulations. 4th ed. 2009. American Pharmacists used with radiation in treatment of primary squamous cell hydroxyurea oral solutions. J Pediatr Hematol Association, Washington, DC. carcinomas of the head and neck (excluding lip cancer); Oncol 2004; 26: 179-184. adjunct in the management of sickle cell patients (to reduce frequency of crises and the need for blood transfusions); has also been usd in the treatment of HIV infeciton, psoriasis, hematologic conditions such as essential thrombocythemia, polycythemia vera, hypereosinophilia, and hyperleukocytosis due to acute leukemia, relapsed AML; treatment of uterine, cervix, and nonsmall cell lung cancers; radiosensitizing agent in the treatment of primary brain tumors.

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Cholestyramine is a bile acid sequestering agent used in Up to 60 days based on USP <795> - The BUD the management of primary hypercholesterolemia, is not later than the time remaining until the pruritus associated with elevated levels of biles acids, earliest expiration date of any Active diarrhea associated with excess fecal bile acids, and Pharmaceutical Ingredient (API) or product, or pseudomembraneous colitis. 60 days, whichever is earlier.

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Treatment of susceptible fungal infections, including Allen LV, Erickson MA. Stability of Trissel LA. Trissel's Stability of Compounded candiadiasis, oral thrush, blastomycosis, ketoconazole, metolazone, metronidaozle, Formulations. 4th ed. 2009. American Pharmacists coccidioidomycosis, histoplasmosis, procainamide hydrochloride, and Association, Washington, DC. paracoccidioidomycosis, chronic mucocutaneous spironolactone in extemporaneously candidiasis, as well as certain recalcitrant cutaneous compounded oral liquids. American Journal dermatophytoses; used topicaly for treatment of tinea Health-Systems Pharmacy 1996 (Sept); 53(17): corporis, tinea cruris, tinea versicolor, cutaneous 2073-8. candidiasis, and seborrheic dermatitis; shampoo is used for dandruff.

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Treatment of mild to severe hypertension. Nahata MC. Stability of labetalol hydrochloride Trissel LA. Trissel's Stability of Compounded in distilled water, simple syrup, and 3 fruit Formulations. American Pharmaceutical juices. DICP Ann Pharmacother 1991; 25: 465- Assocation: Washington, DC 1996. 9.

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A major amino acid in protein that is involved in the Up to 28 days based on USP <795> - The BUD Glucose-Alanine cycle. Alanine Transaminase (ALT) is a is not later than the time remaining until the catalyst used primarily as a mechanism for skeletal muscle earliest expiration date of any Active to eliminate nitrogen while replenishing its energy supply. Pharmaceutical Ingredient (API) or product, or 28 days, whichever is earlier.

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Inborn error of metabolism or inherited citrullinemia Up to 14 days based on USP <795> - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 14 days, whichever is earlier.

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Reduction of toxic effects of high dose methotrexate Up to 14 days based on USP <795> - The BUD ("leucovorin rescue"); to diminish the toxicity and is not later than the time remaining until the counteract the effects of imparied methotrexate earliest expiration date of any Active elimination or as an antidote for folic acid antagonist Pharmaceutical Ingredients (API) or product, overdose; treatment of folate deficient megaloblastic or 14 days, whichever is earlier. anemias of infancy, sprue, or pregnancy; nutritional deficiency when oral folate therpay is not possible; adjunctive treatment with sulfadiazine and pyrimethamine to prevent hematologic toxicity; combined with fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer.

Idopathic Parkinson's disease; postencephalitic Nahata MC, Morosco RS, Leguire LE. Nahata MC, Hipple TF. Pediatric Drug Trissel LA. Trissel's Stability of Compounded parkinsonism; symptomatic parkinsonism. Restless leg Development of two stable oral suspensions Formulations. 6th ed. Harvey Whitney Books: Formulations, 4th ed. Washington, DC: American syndrome. of levodopa-carbidopa for children with Cincinnati, OH. 2010. Pharmacists Association; 2009. amblyopia. J Pediatr Ophthal Strab. 2000; 37: 333-377.

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Lacerations prior to cleaning and suture Up to 60 days - The BUD is not later than the Philadelphia CH. Preparation of LET gel. Children's time remaining until the earliest expiration Hospital of Philadelphia 6/92. 1997: 1 (July): 1-10. date of any Active Pharmaceutical Ingredient (API) or 60 days, whichever is earlier.

Treatment of hypertension, either alone or in combination Nahata MC, Morosco RS. Stability of lisinopril Trissel LA. Trissel's Stability of Compounded with other antihypertensive agents; adjunctive therapy in in two liquid dosage forms. Ann Pharmacother Formulations, 4th ed. Washington, DC: American treatment of heart failure; treatment of acute myocardial 2004; 38: 396-9. Pharmacists Association; 2009. infarction (MI) with 24 hours in hemodynamically-stable patients to improve survival.

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Treatment of a deficiency of this essential branched-chain Up to 30 days based on USP <795> - The BUD Personal Communication, Lederle Laboratories, amino acid. is not later than the time remaining until the 1993. earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 30 days, whichever is earlier.

An essential amino acid necessary in the biosynthesis of Up to 14 days based on USP <795> - The BUD cysteine. is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical

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Treatment of hypertension alone or in combination with Losartan (Cozaar). [Package insert.] Merck & Nahata MC, Pai VB. Pediatric Drug Formulations. other antihypertensive agents; treatment of diabetic Co., Inc, Whitehouse Station, NJ. Revised 11- 6th ed. Cincinnati, OH. Harvey Whitney Books Co.; neuropathy in patients with type 2 diabetes mellitus 2011. 2011. (noninsulin dependent, NIDDM) and hypertension; reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy; has also been used to reduce proteinuria in children with chronic kidney disease, either as monotherapy or in addition to ACE inhibitor therapy, and in Marfan's Syndrome to slow the rate of progression of aortic-root dilation.

Treatment of a deficiency of this essential branched-chain Up to 14 days based on USP <795> - The BUD amino acid. is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 14 days, whichever is earlier.

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Oral mucositis secondary to chemotherapy and Up to 180 days per many years of experience radiotherapy. and USP <795> - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or 6 months, whichever is earlier.

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Treatment and prevention of hypomagnesemia, treatment Up to 30 days based on USP - The BUD is not later than the seizures associated with acute nephritis; prevention and time remaining until the earliest expiration treatment of seizures in severe pre-eclampsia or date of any Active Pharmaceutical Ingredient eclampsia; prevention of premature labor; adjunctive (API) or product, or 30 days, whichever is treatment of bronchodilation in moderate to severe acute earlier. asthma.

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Chronic ear infection. Up to 180 days per USP <795> - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or 6 months, whichever is earlier.

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In conjunction with methotrexate for maintenance therapy Nahata MC, Pai VB. Pediatric Formulations 6th in childhood ALL; use in combination regimens for the ed. Cincinnati, OH: Harvey Whitney Books Co, treatement of AML, CML, and non-hodgkins lymphoma. 2011.

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Management of moderate to severe pain unresponsive to Up to 14 days based on USP <795> - The BUD non-narcotics; used in narcotic detoxification maintenance is not later than the time remaining until the programs and for the treatment of iatrogenic narcotic earliest expiration date of any Active dependency. Pharmaceutical Ingredient (API) or product, or 14 days, whichever is earlier.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Palliative treatment of hyperthyroidism, to return the The beyond-use date (BUD) is defaulted up to Allen LV Jr. Methimazole 10 mg / mL Oral Liquid, hyperthyroid patient to a normal metabolic state prior to 14 days based on USP <795> for Aqueous Veterinary. IJPC 2005; 9(3): 229. thyroidectomy, and to control thyrotoxic crisis that may Formulations and Children's Medical Center accompany thyroidectomy. standard of care - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 14 days, whichever is earlier.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Management of mild to moderate hypertension; treatment Allen LV, Erickson. Stability of ketoconazole, Trissel LA. Trissel's Stability of Compounded of edema in congestive heart failure (CHF), nephrotic metolazone, metronidazole, procainamide Formulations, 4th ed. Washington, DC: American syndrome, and impaired renal function. hydrochloride, and spironolactone in Pharmacists Association; 2009. extemporaneously compounded oral liquids. American Journal of Health-System Pharmacy 1996; 53(17): 2073-8.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Treatment of hypertension, alone or in combination with Allen LV, Erickson MA. Stability of labetalol Trissel LA. Trissel's Stability of Compounded other agents, angina pectoris, and hemodynamically-stable hydrochloride, metoprolol tartrate, verapamil Formulations, 4th ed. Washington, DC: American acute myocardial infarction, ventricular arrhythmias, and hydrochloride, and spironolactone with Pharmacists Association; 2009. atrial fibrillation and atrial flutter; multifocal atrial hydrochlorothiazide in extemporaneously tachycardia; symptomatic treatment of hypertrophic compounded oral liquids. American Journal of obstructive cardiomyopathy; essential tremor, and Health-System Pharmcy 1996, 53: 2304-09 migraine headache prophylaxis.

Treatment of susceptible anaerobic bacerial and protozoal Allen LV, Erickson MA. Stability of Trissel LA. Trissel's Stability of Compounded infections in the following conditions; amebiasis (liver Ketoconazole, Metolazone, Metronidazole, Formulations. 4th ed. 2009. American Pharmacists abcess, dysentary), giardiasis, symptomatic and Procainamide Hydrochloride, and Assocation: Washington, DC. asymptomatic trichomoniasis; infections of skin and skin Spironolactone in Extemporaneously structure, bone and joint, central nervous system, Compounded Oral Liquids. American Journal gynecological, intra-abdominal, respiratory tract (lower) of Health-Systems Pharmacy 1996; 53(17): and systemic anaerobic bacterial infections; endocarditis; 2073-8. surgical prophylaxis (colorectal); treatment of antibiotic- associated pseudomembranous colitis (AAPC) caused by C. difficile; bacterial vaginosis.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Management of serious ventricular arrhythmias; Nahata MC, Morosco RS, Hipple TF. Stability of Trissel LA. Trissel's Stability of Compounded suppression of premature ventricular contractions; diabetic Mexiletine in Two Extemporaneous Liquid Formulations. 4th ed. 2009. American Pharmacists neuropathy. Formulations Stored Under Refrigeration and Association, Washington, DC. at Room Temperature. J Am Pharm Assoc 2000; 49(2): 257-259.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Constipation in children. Up to 24 hours - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 24 hours, whichever is earlier.

Glycerin, High Osmolarity Enema compound for The beyond-use date (BUD) is defaulted up to constipation in children. 180 days based on USP and Children's Medical Center standard of care - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 180 days, whichever is earlier.

Page 1036 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

When combined with Milk for rectal enema: constipation Up to 180 days based on USP.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Treatment of itching due to increased bilirubin and Fawcett JP, Morgan NC, Woods DJ. Trissel LA. Trissel's Stability of Compounded cholestasis in pre-liver transplant patients who are unable Formulation and stability of naltrexone oral Formulations. 4th ed. 2009. American Pharmacists to swallow tablets. Dose of 0.05 mg / kg / dose every 4 to 6 liquid for rapid withdrawal from methadone. Association, Washington, DC. hours. Treatment of ethanol dependence; blockade of the Ann Pharmacother 1997; 31: 2191-5. effects of exogenously administered opioids.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Orally to prepare gastrointestinal tract for surgery; treat Up to 14 days based on USP <795> - The BUD minor skin infections; treatment of diarrhea caused by E. is not later than the time remaining until the Coli; adjunct in the treatment of hepatic encephalopahty. earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 14 days, whichever is earlier.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

When combined with Molasses for rectal enema: Up 180 days based on USP.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Treatment of uncomplicated acute illness due to influenza Oseltamivir Phosphate (Tamiflu). [Package A and B infection in patients who have been symptomatic Insert]. Genentech USA, Inc. Revised 3/2011. for no more than 2 days; prophylaxis of influenza A and B exposures that occur before (or less than 2 weeks after) vaccination with inactivated vaccine, or in years when circulating strains differ from those included in the vaccine (oseltamivir is not a substitute for annual flu vaccination); or preventing influenza. Emergency Use: Treatment of influenza in patients symptomatic for >2 days and / or in patients with severe illness (ie, sick enough to require hospitalization).

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Symptomatic relief of urinary burning, itching, frequency Up to 14 days based on USP <795> - The BUD and urgency in association with urinary tract infection, or is not later than the time remaining until the following urologic procedures. earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 14 days, whichever is earlier.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Pevention and treatment of hypoprothrombinemia caused Nahata MC, Pai VB, Hipple TF. Pediatric Drug Trissel LA. Trissel's Stability of Compounded by vitamin K deficiency or anticoagulant-induced Formulations. 6th ed. Harvey Whitney Books: Formulations. 4th ed. 2009. American Pharmacists hypoprothrombinemia; hemorrhagic disease of the Cincinnati, OH. 2011. Association, Washington, DC. newborn.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Used as a quantimetrix sweat controls for testing of cystic The beyond-use date (BUD) is defaulted up to fibrosis (CF). 90 days based on USP <795>, and Children's Children's Medical Center Policy, Pathology Medical Center Policy, Pathology Department Department Technical Document: Sweat Chloride Technical Document: Sweat Chloride Analysis Analysis No. HM 16.07. No. HM 16.07and discussion with pharmacy and lab directors. The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 90 days, whichever is earlier.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Treatment or prevention of hypokalemia. Ketogenic diet Up to 30 days based on USP - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 30 days, whichever is earlier.

Treatment or prevention of hypokalemia. Ketogenic diet patients only.

Page 1074 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Reduce thyroid vascularity prior to thyroidectomy and Up to 7 days based on USP <795>, FDA Home Home Preparation Procedure for Emergency management of thyrotoxic crisis. Preparation Procedure below, discussion with Administration of Potassium Iodide Tablets to pharmacy director and regulatory affairs Infants and Small Children. pharmacist and Children's Medical Center http://www.fda.gov/downloads/Drugs/Emergency standard of care - The BUD is not later than Preparedness/BioterrorismandDrugPreparedness/ the time remaining until the earliest expiration ucm072757.pdf Accessed 6-11-2013. date of any Active Pharmaceutical Ingredient (API) or product, or 7 days, whichever is earlier.

Treatment and prevention of hypophosphatemia; source of Up to 30 days based on USP - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 30 days, whichever is earlier.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

In conjuction with a blood schizonticidal agent to provide Nahata MC, Pai VB. Pediatric Drug Trissel LA. Trissel's Stability of Compounded radical cure of P. vivax or P. ovale malaria after a clinical Formulations. 6th ed. Cincinnati, OH. Harvey Formulations. 4th ed. 2009. American Pharmacists attack has been confirmed by blood smear or serologic Whitney Books Co.; 2011. Association, Washington, DC. titer; prevention of relapse of P. ovale or P. vivax malaria; malaria postexposure prophylaxis.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Palliative treatment of hyperthyroidism; adjunct to Nahata MC, Morosco RS, Trowbridge JM. Trissel LA. Trissel's Stability of Compounded ameloriate hyperthyroidism in preparation for surgical Stability of Propylthiouracil in Formulations. 4th ed. 2009. American Pharmacists treatment of radioactive iodine therapy; has also been Extemporaneously Prepared Oral Suspensions Association, Washington, DC. used in the managemnt of thyrotoxic crisis. at 4 and 25 Degrees C. Am J Health-Syst Pharm 2000; 57(12): 1141-3.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

In combination with other antituberculosis agents in the Nahata MC, Morosco RS, Peritore SD. Stability Trissel LA. Trissel's Stability of Compounded treatment of mycobacterium tuberculosis infection of pyrazinamide in two suspensions. Amer J Formulations. 4th ed. 2009. American Pharmacists (especially useful in disseminated and meningeal Health- Syst Pharm 1995; 2: 1558-60. Association, Washington, DC. tuberculsos); CDC currently recommends a 3 or 4 multidrug regimen which includes pyrazinamide, rifampin, isoniazid, and at times ethambutol or streptomycin for the treatment fo tuberculosis.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Prevention and treatment of vitamin B6 deficiency, The beyond-use date (BUD) is defaulted up to pyridoxine-dependent seizures in infants; drug-induced 14 days based on USP <795> for Aqueous deficiency (eg, isoniazid or hydralazine); acute intoxication Formulations and Children's Medical Center of isoniazid, cycloserine, hydrazine, mushroom (genus standard of care - The BUD is not later than Gyromitra). the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 14 days, whichever is earlier.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Used in conbination with sulfadiazine for treatment of Nahata MC, Morosco RS, Hipple TF. Stability of Trissel LA. Trissel's Stability of Compounded toxoplasmosis; used in combination with dapsone as Pyrimethamine in a Liquid Dosage Formulations. 4th ed. 2009. American Pharmacists primary or secondary prophylaxis for Pneumocystis jiroveci Formulation Stored for Three Months. Am J Association, Washington, DC. in HIV -infected patients; has been used for Health-Syst Pharm 1997; 54: 2714-6. chemoprophylaxis of malaria but due to severe adverse reactions and reports of resistance of pyrimethamine, other antimalarial agents are now generally preferred.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Prevention of disseminated Mycobacterium aviium Haslam JL, Egodage KL, Chen Y, et al. Stability complex (MAC) in patients with advanced HIV infection; of rifabutin in two extemporaneously Trissel LA. Trissel's Stability of Compounded utilized in multiple drug regimens for treatment of MAC; compounded oral liquids. Am J Health System Formulations, 4th ed. Washington, DC: American alternative to rifampin as prophylaxis for latent Pharm 1999, 56(4): 333-6. Pharmacists Association; 2009. tuberculosis infection (LTBI) or part of multidrug regimen for treatment of active tuberculosis infection; prophylaxis of Mycobacterium avium complex in children > 6 years; add-on therapy for severe Mycobacterium avium complex infection.

Used in combination with other antitubercular drugs for Nahata MC, Morosco RS, Hipple TF. Effect of Trissel LA. Trissel's Stability of Compounded the treatment of active tuberculosis; elimination of Preparation Method and Storage on Rifampin Formulations, 4th ed. Washington, DC: American meningococci from asymptomatic carriers; prophylaxis in Concentration in Suspensions. Am Pharmacists Association: 2009. contacts of patients with Haemophilus Influenzae type B Pharmacother 1994; 28(2): 182-5 infection; used in combination with other anti-infectives in the treatment of staphylococcal infections.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Treatment of travelers' diarrhea caused by noninvasive Cober MP, Johnson CE, Lee J, Currie K. Nahata MC, Pai VB. Pediatric Drug Formulations. strains of E. coli; reduction in the risk of overt hepatic Stability of extemporaneously prepared 6th ed. Cincinnati, OH. Harvey Whitney Books Co.; encephalopathy (HE) recurrence; alternative treatment for rifaximin oral suspensions. Am J Health-Syst 2011. Clostridium difficile-associated diarrhea (CDAD). Pharm 2010; 67(2): 287-289.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

As part of glutathione peroxidase which protects cell The beyond-use date (BUD) is defaulted up to components from oxidative damage due to peroxides 14 days based on USP <795> for Aqueous produced in cellular metabolism. Prevent and correct Formulations and Children's Medical Center selenium trace metal deficiency. standard of care - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 14 days, whichever is earlier.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Ulcerative colitis, diversion colitis and other inflammatory The beyond-use date (BUD) is defaulted up to colonic disease processes. 14 days based on USP <795> for Aqueous Formulations and Children's Medical Center standard of care - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 6 months, whichever is earlier.

Pulmonary hypertension in pediatric patients. Nahata MC, Morosco RS, Brandy MT. Extemporaneous Sildenafil Citrate Oral Suspensions for the treatment of Pulmonary Hypertension in children. Am J Health-Syst Pharm 2006; 63: 254-257.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Treatment of facial angiofibromas. Stability is defaulted up to 30 days due to manufacturer instructions that the bottle should be discarded 30 days after opening - The BUD is not later than the time remaining until the earliest expiration date of any component or 30 days, whichever is earlier.

Page 1097 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Adjunctive therapy for the prevention and treatment of Beyond-use date is extrapolated to 30 days hyperammonemia due to suspected or proven urea cycle based on useage of sodium benzoate 0.1% (1 disorders (enzyme deficiency in combination with mg / mL) to preserve foods and arginine). pharmaceuticals for years.

Management of metabolic acidosis; antacid; alkalinization of urine and stabilization of acid base status.

Management of metabolic acidosis; antacid; alkalinization Up to 30 days based on conservative of urine and stabilization of acid base status. extrapolation based on the injectable commercial product stability, - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 30 days, whichever is earlier.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Restoration of sodium ion in hyponatremia, reduction of The beyond-use date (BUD) is defaulted up to intracranial pressure (ICP) in head trauma patients, 90 days based on USP <795> and that a improvement of mucociliary clearnace and airway commercial product is available on the market hydration in cystic fibrosis and acute viral bronchiolitis, with at least a 2 year expiration date - The reduction of corenal edema, prevention of muscle cramps BUD is not later than the time remaining until and heat prostration. the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 90 days, whichever is earlier.

Restoration of sodium ion in hyponatremia, reduction of intracranial pressure (ICP) in head trauma patients, improvement of mucociliary clearnace and airway hydration in cystic fibrosis and acute viral bronchiolitis, reduction of corenal edema, prevention of muscle cramps and heat prostration.

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IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Used as quantimetrix sweat controls for testing of cystic Up to 90 days per Pathology Department Children's Medical Center Policy, Pathology fibrosis (CF). Technical Document: Sweat Chloride Analysis Department Technical Document: Sweat Chloride No. HM 16.07. The BUD is not later than the Analysis No. HM 16.07. time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 90 days, whichever is earlier.

Page 1106 of 1183 25 February 2014

IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances

Treatment and prevention of hypophosphatemia, short- The beyond-use date (BUD) is defaulted up to Allen LV Jr. Sodium Phosphates Injection. IJPC Sodium Phosphates Injection. [Package Insert]. term tretment of constipation (ral and rectal); evacuation 30 days based on USP <795>, conservative 2012: 16(1); 78. Hospira, Inc., Lake Forest, IL. Revised 4/2004. of the colon for rectal and bowel exams. extrapolation based on the injectable commercial product stability, discussion with pharmacy director and regulatory affairs pharmacist and Children's Medical Center standard of care - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 30 days, whichever is earlier.

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Treat, suppress, or prevent the recurrence of life- Nahata MC, Morosco RS. Stability of two liquid Sidhom MD, Taft DR, Rivera N, et al. Stability of threatening ventricular arrhythmias. formulations at two temperatures. Ann sotalol hydrochloride in extemporaneously Pharmacother 2003; 37: 506-509. prepared oral suspension formulations. IJPC 2005; 9(5): 402-406.

Management of edema associated with CHF, cirrhosis of Allen LV, Erickson MA. Stability of the liver accompanied by edema or ascites, and nephrotic ketoconazole, metolazone, metronidaozle, syndrome; treatment of essential hypertension, primary procainamide hydrochloride, and hyperaldosteronism, hypokalemia, and hirsutism; spironolactone in extemporaneously treatment of severe heart failure (NYHS class III-IV) to compounded oral liquids. American Journal increase survival and reduce hospitalizations when used in Health-Systems Pharmacy 1996 (Sept); 53(17): addition to standard therapy. 2073-8.

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Management of edema associated with CHF, cirrhosis of Allen LV, Erickson MA. Stability of labetalol the liver accompanied by edema or ascites, and nephrotic hydrochloride, metoprolol tartrate, verapamil syndrome; treatment of essential hypertension, primary hydrochloride, and spironolactone with hyperaldosteronism, hypokalemia, and hirsutism; hydrochlorothiazide in extemporaneously treatment of severe heart failure (NYHS class III-IV) to compounded oral liquids. American Journal of increase survival and reduce hospitalizations when used in Health-System Pharmcy 1996, 53: 2304-09. addition to standard therapy. Management of mild to moderate hypertension; treatment of edema in CHF and nephrotic syndrome.

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Adjunctive treatment in toxoplasmosis; treatment of Mace A, Fabienne A, Burgot G. Stability of urinary tract infections and nocardiosis; rheumatic fever sulfadiazine in an extemporaneously prophylaxis in penicillin-allergic patient; uncomplicated compounded oral suspension. Amer Soc attack of malaria. Health-System Pharmacists Midyear Meeting; December 2-6, 2001; Orlando, Fl. Presented December 3.

Management of ulcerative colitis, active Crohn's disease Jew RK, Mullen RJ, Soo-Hoo W. Written communication Children's Medical Center and juvenile arthritis. Extemporaneous Formulations. The Children's Dallas. Kabi Pharmacia, September 1, 1993. Hospital of Philadelphia. ASHP, 2003.

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Immunosuppresant, prevention of organ rejection in solid Jacobson PA, Johnson CE, West NJ, Foster JA. organ transplantaion and tretment of graft versus host Stability of tacrolimus in an extemporaneously disease in allogeneic stem cell transplantation patients. compounded oral liquid. Am J Health-Syst Pharm. 1997 Jan 15; 54: 178-180.

A phosphodiesterate 5 (PDE5) inhibitor for pulmonary Pettit RS, Johnson CE, Caruthers RL. Stability of arterial hypertension (PAH). Tadalafil oral suspension. Am J Health-Syst Pharm 2012; 69(7): 592-594.

Treatment of signs and symptoms of benign prostatic 180 days per USP <795>. The BUD is not later hyperplasia (BPH). Symptomatic treatment of bladder than the time remaining until the earliest outlet obstruction or dysfunction. expiration date of any product used or Active Pharmaceutical Ingredient (API) or 90 days, whichever is earlier.

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Treatment of refractory anaplastic astrocytoma with Trissel LA, Zhang Y, Koontz SE. Temozolomide Trissel LA. Trissel's Stability of Compounded relapse after initial therapy with a nitrosurea and Stability in Etemporaneously Compounded Formulations. 4th ed. 2009. American Pharmacists procarbazine; treatment of newly-diagnosed or recurrent Oral Suspensions. IJPC 2006; 19(5): 396-399. Association, Washington, DC. glioblastoma multiforme; meastatic melanoma, anaplastic oligodendroglioma, ependymoma, recurrent brain stem glioma, medulloblastoma/PNET, neuroblastoma, cutaneous T-Cell lymphomas (mycosis fungoides [MF] and Sezary Syndrome [SS]), carcinoid tumors.

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Thiamine deficiency including beriberi, Wernicke's The beyond-use date (BUD) is defaulted up to encephalopathy syndrome, and peripheral neuritis 14 days based on USP <795> for Aqueous associated with pellagra; various genetic metabolic Formulations and Children's Medical Center disorders. standard of care - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 14 days, whichever is earlier.

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Remission induction and remission consolidation treatment Aliabadi HM, Romanick M, Somayaji V, of acute myelogenous (nonlymphocytic) leukemia. Mahdipoor P, Lavasanifar A. Stability of compounded thioguanine oral suspensions. Am J Health-Sys Pharm 2011; 68(10): 900-908.

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Topical absorbent and protective agent with antimicrobial properties.

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Treatment of parasitic diseases such as amoebiasis and giardiasis.

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Seizure disorders and migraines. Nahata MC, Pai VB, and Hipple TF. Pediatric Nahata MC, Morosco RS, Willhite EA. Topiramate Drug Formulations, 6th ed, Cincinnati, OH: stability in two oral suspensions stored in plastic Harvey Whitney Books Co, 2011. prescription bottles at two temperatures. (poster) Concentration changed from 6 mg / mL to 5 36th American Soc of Health-Syst Pharmacists mg / mL per professional judgement. Making Midyear Meeting; December 2-6, 2001; New dosing easier. Orleans, LA. Presented December 5.

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Opsiclonus, myoclonus and major depression disorder, Up to 14 days based on USP , discussion with pharmacy director Oral Liquid. Int J Pharmaceutical Compounding Druggist 1992; 205: 58. and regulatory affairs pharmacist and 2006:10 (2); 146. Children's Medical Center standard of care - The BUD is not later than the time remaining until the earliest expiration date of any Active Pharmaceutical Ingredient (API) or product, or 14 days, whichever is earlier.

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Verruca vulgaris, Verruca plana juvenilis and Verruca Allen LV. Basics of Compounding for the plantaris (Warts), necrotising agent, peeling agent, Treatment of Warts. Int J of Pharmaceutical Allen LV. Trichloroacetic Acid 20% Topical Solution. keralytic, desquamation of horny layer of skin. Compounding 2004; 8(2): 126-129. Int J of Pharmaceutical Compounding 2004; 8(2): 127.

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Prophylaxis and tretment of urinary tract infections, Nahata MC. Stability of Trimethoprim in an Nahata MC, Hipple TF. Pediatric Drug pneumonia, pneumocystis jiroveci prophylaxis and otitis Extemporaneous Liquid Dosage Form. J Formulations. 6th ed. Harvey Whitney Books: media. Pediatr Pharm Pract 1997 2(2):P 82-84. Cincinnati, OH. 2010.

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Keratolytic agent to soften nails or skin; OTC: Moisturizer The beyond-use date (BUD) is defaulted up to Ureaphil (Urea) IV (Intravenous). [Package Insert]. for dry, rough skin. Treatment of chronic syndrome of 30 days based on USP <795>, a conservative Hospira, Inc., Lake Forest, IL. No longer on the inappropriate antidiuresis (SIADH) in children. extrapolation based on the injectable market. commercial product. The BUD is not later than the time remaining until the earliest expiration date of any API or product, or 30 days, whichever is earlier.

Keratolytic agent to soften nails or skin; OTC: Moisturizer 9 days Refrigeration default to USP <797> Ureaphil (Urea) IV (Intravenous). [Package Insert]. for dry, rough skin. Bladder irrigant. Hospira, Inc., Lake Forest, IL. No longer on the market.

Suppresses hepatic synthesis of cholesterol and aids in the Johnson CE, Nesbitt J. Stability of ursodiol in Johnson CE, Streetman DD. Stability of oral destruction of biliary cholesterol and dissolution of an extemporaneously compounded oral liquid. suspensions of ursodiol made from tablets. Am J cholesterol gallstones, primary biliary cirrhosis and other Amer J Health Syst Pharm 1995; 52: 1798-800. Health-Syst Pharm 2002; 59: 361-3. hepatobiliary disorders.

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Chickenpox, Antiviral Agent, herpes, shingles. Fish DN, Vidaurri VA, Deeter RG. Stability of Valacyclovir. [Package Insert]. Glaxo Smith Kline, valacyclovir hydrochloride in Research Triangle Park, NC, September 2008. extemporaneously prepared oral liquids. Am J Health-Syst Pharm. 1999 Oct. 1; 56: 1957-60.

Clostridium Difficile Colitis Sterile Vancomycin HCl, USP. [Package insert]. Ensom MH, Decarie D. Lakhani A. Stability of Akorn-Strides, Inc., Lake Forest, IL. July 2009. vancomycin 25 mg / mL in Ora-Sweet and water in unit-dose cups and plastic bottls at 4 and 25 degrees C. CJHP 2010; 63(5): 366-372.

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Treatment of hypertension, angina pectoris (vasospastic, Nahata MC. Stability of verapamil in an Allen LV, Erickson MA. Stability of labetalol chronic stable, unstable); supraventricular tachyarrhythmia extemporaneous liquid dosage form. J App hydrochloride, metoprolol tartrate, verapamil [PSVT (prophylaxis), atrial fibrillation / flutter (rate control). Ther 1997; 1: 271-3. hydrochloride, and spironolactone with hydrochlorothiazide in extemporaneously compounded oral liquids. American Journal of Health-System Pharmcy 1996, 53: 2304-09

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Treatment of zinc deficiency. 30 days if repackaging the injectable into an oral bottle, 14 days if diluting the injection with Sterile Water for Irrigation. 3-9 months for injection that has been sterility checked.

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Treatment of seizure disorders, epilepsy. Nahata MC, Morosco RS, Boster EA. Stability Nahata MC, Pai VB. Pediatric Formulations 6th ed. Abobo CV, Wei B, Liang D. Stability of zonisamide of zonisamide in two extemporaneously Cincinnati, OH: Harvey Whitney Books Co, 2011. in extemporaneously compounded oral solutions. prepared or dosage forms stored in plastic Amer J Health-Syst Pharm 2009; 66: 1105-11-0. prescription bottles at two temperatures. (poster) 39th American Socity of Health- System Pharmacists Midyear Meeting; December 5-9, 2004; Orlando, FL. Precented December 8.

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