§ 429.60 21 CFR Ch. I (4–1–96 Edition)

warrants a refund from the fund col- cation, Inspection and Other Services, lected during such period, he shall Food and Drug Administration.’’ make ratable refunds to those persons [39 FR 11750, Mar. 29, 1974, as amended at 42 to whom the services were rendered FR 27227, May 27, 1977; 48 FR 788, Jan. 7, 1983; and charged. 60 FR 56516, Nov. 9, 1995] (b) The fees for requests for certifi- cation submitted under § 429.40 are as Subpart G—Records follows: (1) $2,400 for each master lot or mix- § 429.60 Records of distribution. ture of two or more master lots or (a) The person to whom a certificate parts thereof. is issued shall keep complete records (2) $1,700 for each dosage form batch. showing each shipment and other deliv- (3) The fees established in this para- ery (including exports) of each batch or graph may increase as Federal salary part thereof, by the person requesting costs increase. The rate of increase will certification, and showing each such be no higher than Federal salary in- shipment and delivery into, or from creases, commencing with pay raises any place in, any State or Territory, made by any person subject to his con- on or after January 1, 1997. Notification trol, including records showing the of the exact fees established and ad- date and quantity of each such ship- justments will be communicated di- ment and delivery and the name and rectly to the manufacturers of insulin post office address of the person to products. whom such shipment or delivery was (c) A person requiring continuing cer- made. tification services may maintain an ad- (b) Upon the request of any officer or vance deposit of the estimated costs of employee of the Food and Drug Admin- such services for a period of 2 months istration or of any other officer or em- or more. Such deposits shall be debited ployee of the United States, acting on with fees for services rendered, but behalf of the Secretary, the person to shall not be debited for any fee the whom a certificate is issued, at all rea- amount of which is not definitely spec- sonable hours within 2 years after dis- ified in these regulations unless the de- posal of all the batch covered by such positor has previously requested the certificate, shall make such records performance of the services to be cov- available to any such officer or em- ered by such fee. A monthly statement ployee, and shall accord to such officer for each such advance deposit shall be or employee full opportunity to make rendered. inventory of stocks of such batch on (d) The unearned portion of any ad- hand and otherwise to check the cor- vance deposit made pursuant to para- rectness of such records. graph (b) or (c) of this section shall be refunded to the depositor upon his ap- PART 430—ANTIBIOTIC DRUGS; plication. GENERAL (e) All advance deposits required by the regulations in this part 429 shall be Subpart A—General Provisions paid by money order, bank draft, or Sec. certified check drawn to the order of 430.3 Definitions applicable to all certifiable the Food and Drug Administration, antibiotic drugs. collectible at par at Washington, DC. 430.4 Definitions of antibiotic substances. All deposits shall be forwarded to the 430.5 Definitions of master and working standards. Food and Drug Administration, De- 430.6 Definitions of the terms ‘‘unit’’ and partment of Health and Human Serv- ‘‘microgram’’ as applied to antibiotic ices, Washington, DC 20204, whereupon substances. after making appropriate record there- of they will be transmitted to the Chief Subpart B—Antibiotic Drugs Affected by Disbursing Officer, Division of Dis- the Drug Amendments of 1962 bursement, Treasurer of the United 430.10 Certification or release of antibiotic States, for deposit to the special ac- drugs affected by the drug amendments count ‘‘Salaries and Expenses, Certifi- of 1962.

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AUTHORITY: Secs. 201, 501, 502, 503, 505, 507, (2) Streptomycin. Each of the several 701 of the Federal Food, Drug, and Cosmetic antibiotic substances produced by the Act (21 U.S.C. 321, 351, 352, 353, 355, 357, 371); growth of Streptomyces griseus, and each secs. 215, 301, 351 of the Public Health Service of the same substances produced by Act (42 U.S.C. 216, 241, 262). any other means, is a kind of strepto- mycin. Subpart A—General Provisions (3) Dihydrostreptomycin. Each of the antibiotic substances produced by hy- § 430.3 Definitions applicable to all drogenation of streptomycin, and each certifiable antibiotic drugs. of the same substances produced by (a) The definitions and interpreta- any other means, is a kind of dihydro- tions contained in section 201 of the streptomycin. Federal Food, Drug, and Cosmetic Act (4) Chlortetracycline. Each of the sev- shall be applicable to such terms when eral antibiotic substances produced by used in the regulations in this chapter the growth of Streptomyces aureofaciens, covering the certification of antibiotic and each of the same substances pro- and antibiotic-containing drugs. duced by any other means is a kind of (b) The term Commissioner means the chlortetracycline. Commissioner of Food and Drugs and (5) Tetracycline. Each of the several any other officer of the Food and Drug antibiotic substances produced by the Administration whom he may des- hydrogenation of chlortetracycline, ignate to act in his behalf for the pur- and each of the same substances pro- pose of the regulations for the certifi- duced by any other means, is a kind of cation of antibiotic and antibiotic-con- tetracycline. taining drugs. (6) Chloramphenicol. Each of the sev- (c) The term act means the Federal eral antibiotic substances produced by Food, Drug, and Cosmetic Act and the growth of Streptomyces venezuelae, amendments thereto. (52 Stat. 1040 et and each of the same substances pro- seq.; 21 U.S.C. 301–392). duced by any other means, is a kind of (d) The term U.S.P. means the official chloramphenicol. Pharmacopeia of the United States, in- (7) Bacitracin. Each of the several an- cluding supplements thereto. The term tibiotic substances produced by the N.F. means the official National For- growth of Bacillus subtilis var. Tracy, mulary, including supplements thereto. and each of the same substances pro- (e) The term batch means a specific duced by any other means, is a kind of homogeneous quantity of a drug. bacitracin. (f) The term batch mark means an (8) [Reserved] identifying mark or other identifying (9) Amphotericin. Each of the anti- device assigned to a batch by the man- biotic substances produced by the ufacturer or packer thereof. growth of Streptomyces nodosus, and (g) The term manufacture does not in- each of the same substances produced clude the use of a drug as an ingredient by any other means, is a kind of in compounding any prescription is- amphortericin. sued by a practitioner licensed by law (10) Colistin. Each of the antibiotic to administer such drug. substances produced by the growth of Bacillus polymyxa var. colistinus, and [39 FR 18925, May 30, 1974] each of the same substances produced by any other means, is a kind of § 430.4 Definitions of antibiotic sub- colistin. stances. (11) Cycloserine. Each of the anti- (a) The following are definitions of biotic substances produced by the antibiotic substances: growth of Streptomyces orchidaceus, and (1) Penicillin. Each of the several an- each of the same substances produced tibiotic substances (e.g., penicillin F, by any other means, is a kind of cyclo- penicillin G, penicillin X) produced by serine. the growth of Penicillium notatum or (12) Erythromycin. Each of the anti- Penicillium chrysogenum, and each of biotic substances produced by the the same substances produced by any growth of Streptomyces erythreus, and other means, is a kind of penicillin. each of the same substances produced

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by any other means, is a kind of eryth- (23) Polymyxin. Each of the antibiotic romycin. substances produced by the growth of (13) Gramicidin. Each of the antibiotic Bacillus polymyxa, and each of the same substances produced by the growth of substances produced by any other Bacillus brevis, and each of the same means, is a kind of polymyxin. substances produced by any other (24) Plicamycin. Each of the antibiotic means, is a kind of gramicidin. substances produced by the growth of a (14) Griseofulvin. Each of the anti- variant of Streptomyces plicatus, and biotic substances produced by the each of the same substances produced growth of Penicillium patulum or by any other means, is a kind of Penicillium griseofulvum, and each of the plicamycin. same substances produced by any other (25) Tyrothricin. Each of the mixtures means, is a kind of griseofulvin. of antibiotic substances produced by (15) Kanamycin. Each of the anti- the growth of Bacillus brevis, and each biotic substances produced by the of the same mixtures of substances pro- growth of Streptomyces kanamyceticus, duced by any other means, is a kind of and each of the same substances pro- tyrothricin. duced by any other means, is a kind of (26) Vancomycin. Each of the anti- kanamycin. biotic substances produced by the (16) Neomycin. Each of the antibiotic growth of Streptomyces orientalis, and substances produced by the growth of each of the same substances produced Streptomyces fradiae, and each of the by any other means, is a kind of same substances produced by any other vancomycin. means, is a kind of neomycin. (27) [Reserved] (17) Novobiocin. Each of the antibiotic (28) Gentamicin. Each of the anti- substances produced by the growth of biotic substances produced by the Streptomyces niveus (known also as growth of Micromonospora purpurea, Streptomyces spheroides), and each of the and each of the same substances pro- same substances produced by any other duced by any other means, is a kind of means, is a kind of novobiocin. gentamicin. (18) Nystatin. Each of the antibiotic (29) Dactinomycin. Dactinomycin is a substances produced by the growth of specific kind of actinomycin produced Streptomyces noursei, and each of the by the growth of Streptomyces parvullus same substances produced by any other or the same antibiotic produced by any means, is a kind of nystatin. other means. (19) Oleandomycin. Each of the anti- (30) Candicidin. Each of the heptaene biotic substances produced by the antibiotic substances produced by the growth of Streptomyces antibioticus, and growth of Streptomyces griseus and each each of the same substances produced of the same substances produced by by any other means, is a kind of any other means is a kind of oleandomycin. candicidin. (20) Troleandomycin. Each of the anti- (31) Cephalosporin. Each of the anti- biotic substances produced by the biotic substances produced by the triacetylation of oleandomycin, and growth of Cephalosporium acremonium, each of the same substances produced and each of the same substances pro- by any other means, is a kind of duced by any other means, is a kind of troleandomycin. cephalosporin. (21) Oxytetracycline. Each of the anti- (32) Lincomycin. Each of the anti- biotic substances produced by the biotic substances produced by the growth of Streptomyces rimosus, and growth of Streptomyces lincolnensis var. each of the same substances produced lincolnensis, and each of the same sub- by any other means, is a kind of oxy- stances produced by any other means, tetracycline. is a kind of lincomycin. (22) Paromomycin. Each of the anti- (33) Demeclocycline. Each of the anti- biotic substances produced by the biotic substances produced by removal growth of Streptomyces rimosus var. of the 6-methyl group from paromomycinus, and each of the same chlortetracycline, and each of the same substances produced by any other substances produced by any other means, is a kind of paromomycin. means, is a kind of demeclocycline.

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(34) Clindamycin. Each of the anti- antibioticus, and each of the same sub- biotic substances produced by the 7- stances produced by any other means is chloro-substitution of the 7(R)hydroxyl a kind of vidarabine. group of lincomycin, and each of the (45) Natamycin. Each of the antibiotic same substances produced by any other substances produced by the growth of means, is a kind of clindamycin. Streptomyces natalensis, and each of the (35) [Reserved] same substances produced by any other (36) Capreomycin. Each of the anti- means, is a kind of natamycin. biotic substances produced by the (46) Daunorubicin. Each of the anti- growth of Streptomyces capreolus, and biotic substances produced by the each of the same substances produced growth of Streptomyces coeruleorubidus by any other means, is a kind of and each of the same substances pro- capreomycin. duced by any other means is a kind of (37) Rifamycin. Each of the several an- daunorubicin. tibiotic substances (e.g., rifamycin A, (47) Sisomicin. A specific one of the rifamycin B, rifamycin SV) produced antibiotic substances produced by the by the growth of Streptomyces growth of Micromonospora inyoensis, mediterranei, and each of the same sub- and the same substance produced by stances produced by any other means, any other means, is a kind of is a kind of rifamycin. sisomicin. (38) Spectinomycin. Each of the anti- (48) Moxalactam. 5-oxa-1- biotic substances produced by the azabicyclo[4.2.0]oct-2-ene-2-carboxylic growth of Streptomyces spectabilis, and each of the same substances produced acid, 7-[[carboxy(4- by any other means, is a kind of hydroxyphenyl)acetyl]-amino]-7- spectinomycin. methoxy-3-[[(1-methyl-1H-tetrazol-5- (39) Mitomycin. Mitomycin is the an- yl)thio]-methyl]-8-oxo-, disodium salt. tibiotic substance produced by the (49) Cefoperazone. Cefoperazone is a growth of Streptomyces caespitosus, and semi-synthetic antibiotic substance each of the same substances produced produced by the acylation of the amino by any other means is a kind of group at the 7 position of 7- mitomycin. aminocephalosporanic acid with α-(4- (40) Doxorubicin. Each of the anti- ethyl-2,3-dioxo-1- biotic substances produced by the piperazinecarboxamido)-α-(4- growth of Streptomyces peucetius var. hydroxyphenyl) acetic acid and intro- caesius, and each of the same sub- duction of a methylthiotetrazol group stances produced by any other means, at the 3 position. is a kind of doxorubicin. (50) Netilmicin. Netilmicin is a semi- (41) Bleomycin. Each of the antibiotic synthetic antibiotic of the substances produced by the growth of aminoglycoside group derived from Streptomyces verticillus and each of the sisomicin, and each of the same sub- same substances produced by any other stances produced by any other means is means is a kind of bleomycin. a kind of netilmicin. It is D-Strepta- (42) Tobramycin. A specific one of the mine, 4-O-[3-amino-6-(aminomethyl)- antibiotic substances produced by the 3,4-dihydro-2H-pyran-2-yl]-2-deoxy-6-O- growth of Streptomyces tenebrarius, and [3-deoxy-4-C-methyl-3-(methylamino)- the same substance produced by any β-L-arabinopyranosyl]-N1-ethyl-, (2S- other means, is tobramycin. cis)-. (43) Amikacin. Each of the antibiotic (51) Cyclosporine. Cyclosporine is a substances produced by the acylation specific cyclic polypeptide consisting of the 1-amino group of the 2-deoxy- of 11 amino acids produced by the streptamine moiety of kanamycin A growth of Cylindrocarpon lucidum Booth with L-(-)-γ)amino-α-hydroxybuyric or Tolypocladium inflatum Gams. acid, and each of the same substances (52) Cefonicid. 5-Thia-1- produced by any other means is a kind azabicyclo[4.2.0]oct-2-ene-2-carboxylic of amikacin. acid, 7-[(hydroxyphenylacetyl)amino]- (44) Vidarabine. Vidarabine is a purine 8-oxo-3[[[1-(sulfomethyl)-1H-tetrazol- glycoside antibiotic substance pro- 5yl]-thio]methyl]-, disodium salt, [6R- duced by the growth of Streptomyces [6α7û(R*)]]. 319

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(53) Clavulanic acid. Clavulanic acid is dimethylamino)ethyl]-1H-tetrazol-5-y1] an antibiotic substance produced by thio] methyl]-3-cephem-4-carboxylic the growth of Streptomyces clavuligerus acid. having the structure described as fol- (61) Mupirocin. Each of the antibiotic lows: Z-(2R, 5R)-3-(2- substances produced by the growth of hydroxyethylidene)-7-oxo-4-oxa-1- Pseudomonas fluorescens, and each of azabicyclo[3.2.0]heptane-2-carboxylic the same substances produced by any acid, and each of the same substances other means, is a kind of mupirocin. produced by any other means, is a kind (62) Cefmetazole. Cefmetazole is an an- of clavulanic acid. tibiotic substance having the chemical (54) Ceftriaxone. Ceftriaxone is a structure described by the following semi-synthetic antibiotic substance name: (6R-cis)-7- produced by the addition of S-2- [[[cyanomethyl)thio]acetyl]amino]-7- benzothiazolyl-2-(2-aminothiazol-4-yl)- methoxy-3-[[(1-methyl-1H- tetrazol-5- 2-methoxyiminothioacetate to the 7 yl)thio]methyl]-8-oxo-5- thia-1- amino group of 7-amino-3-(2,5-dihydro-2 azabicyclo[4.2.0]oct-2- ene-2-carboxylic methyl-5,6-dioxo-1,2,4-triazin-3-yl)- acid. thiomethyl-3-cephem-4-carboxylic acid. (63) Cefpiramide. Cefpiramide is an an- (55) Imipenem monohydrate. Imipenem tibiotic substance having the chemical monohydrate is an antibiotic substance structure described by the following having the chemical structure de- name: (6R, 7R)-7-[(R)-2-(4-hydroxy-6- scribed by the following name: [5R- methyl-nicotinamido)-2-(p- [5α,6α,(R*)]]-6-(1-hydroxyethyl)-3-[[2- hydroxyphenyl)acetamido]-3-[[(1- [(iminomethyl)amino]ethyl]thio]-7- methyl-1H-tetrazol-5-yl)thio]methyl]-8- oxo-1-azabicyclo[3.2.0]-hept-2-ene-2-car- oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene- boxylic acid monohydrate. 2-carboxylic acid. (56) Aztreonam. [2S[2alpha,3beta(Z)]]-2- (64) Clarithromycin. Clarithromycin is [[[1-(2-amino-4-thiazolyl)-2-[(2-methyl- 6-O-methylerythromycin A. 4-oxo-1-sulfo-3-azetidinyl)amino]-2- (65) Azithromycin. Azithromycin is an oxoethylidene]amino]oxy]-2- antibiotic substance having the chemi- methylpropanoic acid. cal structure described by the follow- (57) Sulbactam. Sulbactam is a semi- ing name: synthetic antibiotic substance pro- (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13- duced by the oxidation of the sulfur [(2,6-dideoxy-3-C-methyl-3-O-methyl-α- atom at the 4 position to its dioxide L-ribo-hexopyranosyl)oxy]-2-ethyl- and the deamination at the 6 position 3,4,10-trihydroxy-3,5,6,8,10,12,14- of (2S,5R)-6-amino-3,3-dimethyl-7-oxo-4 heptamethyl-11-[[3,4,6-trideoxy-3- thia-1-azabicyclo[3.2.0]heptane-2-car- (dimethylamino)-β-D-xylo- boxylic acid (6-APA). hexopyranosyl]oxy]-1-oxa-6- (58) Cefmenoxime. Cefmenoxime is 5- azacyclopentadecan-15-one. thia-1-azabicyclo[4.2.0]oct-2-ene-2-car- (66) Cefprozil. Cefprozil is an anti- boxylic acid, 7-[[(2-amino-4-thiazolyl) biotic substance having the chemical (methoxyimino)acetyl]amino]-3-[[(1- structure described by the following methyl-1H-tetrazol-5-yl)thio]methyl]-8- name: (6R,7R)-7-[(R)-2-amino-2-(p- oxo-, [6R-[6-α,7-β(Z)]]-. hydroxyphenyl)acetamido]8-oxo-3-pro- (59) Cefixime. Cefixime is a semi- penyl-5-thia-1-azabicyclo[4.2.0]oct-2- synthetic antibiotic substance pro- ene-2-carboxylic acid. It is a mixture of duced by the acylation of the amino the Z (cis) and E (trans) isomers in an group at the 7 position of 7- approximate ratio of 9:1, respectively. aminocephalosporanic acid with a β-[(2- (67) Idarubicin. Idarubicin is an amino-4-thiazolyl) anthracycline antibiotic substance (carboxymethoxy)imino] acetyl group having the chemical structure de- and the introduction of a vinyl group scribed by the following name: 5,12- at the 3 position. Naphthacenedione, 9-acetyl-7-[(3- (60) Cefotiam. Cefotiam is an anti- amino-2,3,6-trideoxy-α-L-lyxo- biotic substance having the chemical hexopyranosyl)oxy]-7,8,9,10-tetrahydro- structure described by the following 6,9,11-trihydroxy-(7S-cis). name: 7-(R)-[2-(2-amino-4- (68) Loracarbef. Loracarbef is an anti- thiazol)acetamido]-3-[[[1-(2- biotic substance having the chemical

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structure described by the following (vii) Oxacillin. The term ‘‘oxacillin name: (6R,7S)-7-[(R)-2-amino-2- master standard’’ means a specific lot phenylacetamido]-3-chloro-8-oxo-1- of crystalline oxacillin that is des- azabicyclo[4.2.0]oct-2-ene-2-carboxylic ignated by the Commissioner as the acid. standard of comparison in determining (69) Rifabutin. Rifabutin is an anti- the potency of the oxacillin working biotic substance having the chemical standard. structure described by the following (viii) Ampicillin. The term ‘‘ampi- name: (9S,12E,14S,15R,16S,17R,18R,19R, cillin master standard’’ means a spe- 20S,21S,22E, 24Z)-6,16, 18,20- cific lot of crystalline ampicillin that ′ tetrahydroxy-1 -isobutyl-14-methoxy- is designated by the Commissioner as 7,9,15,17,19,21,25-heptamethylspiro[9,4- the standard of comparison in deter- (epoxypentadeca[1,11,13]trienimino)-2H- mining the potency of the ampicillin ′ ′ ′ furo[2 ,3 :7,8]naphth[1,2-d]imidazole-2,4 - working standard. piperidine]-5,10,26-(3H,9H)-trione-16-ac- (ix) Nafcillin. The term ‘‘nafcillin etate. master standard’’ means a specific lot (70) Cefpodoxime proxetil. Cefpodoxime of crystalline nafcillin that is des- proxetil is an antibiotic substance hav- ing the chemical structure described by ignated by the Commissioner as the the following name: (±)-1- standard of comparison in determining Hydroxyethyl(+)-(6R,7R)-7-[2-(2-amino- the potency of the nafcillin working 4-thiazolyl)glyoxylamido]-3- standard. (methoxymethyl)-8-oxo-5-thia-1- (x) Cloxacillin. The term ‘‘cloxacillin azabicyclo[4.2.0]oct-2-ene-2- master standard’’ means a specific lot carboxylate,72-(Z)-(O-methyloxime), of crystalline cloxacillin that is des- isopropyl carbonate (ester). ignated as the standard of comparison (b) [Reserved] in determining the potency of the cloxacillin working standard. [39 FR 18925, May 30, 1974] (xi) Dicloxacillin. The term EDITORIAL NOTE: For FEDERAL REGISTER ci- ‘‘dicloxacillin master standard’’ means tations affecting § 430.4, see the List of CFR a specific lot of dicloxacillin that is Sections Affected in the Finding Aids sec- designated by the Commissioner as the tion of this volume. standard of comparison in determining § 430.5 Definitions of master and work- the potency of the dicloxacillin work- ing standards. ing standard. (a) Master standards—(1) Penicillinand (xii) The term ‘‘hetacillin working salts of penicillin—(i) Penicillin G The standard’’ means a specific lot of ho- term ‘‘penicillin G master standard’ mogenous preparation of hetacillin. means a specific lot of crystalline peni- (2) Streptomycin. The term ‘‘strepto- cillin G that is designated by the Com- mycin master standard’’ means a spe- missioner as the standard of compari- cific lot of streptomycin that is des- son in determining the potency of the ignated by the Commissioner as the penicillin G working standard. standard of comparison in determining (ii) [Reserved] the potency of the streptomycin work- (iii) Penicillin V. The term ‘‘penicillin ing standard. V master standard’’ means a specific (3) Dihydrostreptomycin. The term ‘‘di- lot of crystalline penicillin V that is hydrostreptomycin master standard’’ designated by the Commissioner as the means a specific lot of crystalline dihy- standard of comparison in determining drostreptomycin that is designated by the potency of the penicillin V working the Commissioner as the standard of standard. comparison in determining the potency (iv)—(v) [Reserved] of the dihydrostreptomycin working (vi) Methicillin. The term standard. ‘‘methicillin master standard’’ means a (4) Chlortetracycline. The term specific lot of crystalline methicillin ‘‘chlortetracyclin master standard’’ that is designated by the Commissioner means a specific lot of crystalline as the standard of comparison in deter- chlortetracycline hydrochloride that is mining the potency of the methicillin designated by the Commissioner as the working standard. standard of comparison in determining

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the potency of the chlortetracycline (13) Colistimethate. The term working standard. ‘‘colistimethate master standard’’ (5) Demeclocycline. The term means a specific lot of colistimethate ‘‘demeclocycline master standard’’ designated by the Commissioner as the means a specific lot of crystalline standard of comparison in determining demeclocycline hydrochloride that is the potency of the colistimethate designated by the Commissioner as the working standard. standard of comparison in determining (14) Cycloserine. The term ‘‘cyclo- the potency of the demeclocycline serine master standard’’ means a spe- working standard. cific lot of cycloserine designated by (6) Tetracycline. The term ‘‘tetra- the Commissioner as the standard of cycline master standard’’ means a spe- comparison in determining the potency cific lot of crystalline tetracycline hy- of the cycloserine working standard. drochloride that is designated by the (15) Erythromycin. The term ‘‘erythro- Commissioner as the standard of com- mycin master standard’’ means a spe- parison in determining the potency of cific lot of erythromycin designated by the tetracycline working standard. the Commissioner as the standard of (7) Rolitetracycline. The term comparison in determining the potency ‘‘rolitetracycline master standard’’ of the erythromycin working standard. means a specific lot of crystalline (16) Gramicidin. The term ‘‘gramicidin master standard’’ means a specific lot rolitetracycline that is designated by of gramicidin designated by the Com- the Commissioner as the standard of missioner as the standard of compari- comparison in determining the potency son in determining the potency of the of the rolitetracycline working stand- gramicidin working standard. ard. (17) Griseofulvin. The term ‘‘griseo- (8) Chloramphenicol. The term ‘‘chlor- fulvin master standard’’ means a spe- amphenicol master standard’’ means a cific lot of griseofulvin designated by specific lot of crystalline chlor- the Commissioner as the standard of amphenicol that is designated by the comparison in determining the potency Commissioner as the standard of com- of the griseofulvin working standard. parison in determining the potency of (18) Kanamycin. The term the chloramphenicol working standard. ‘‘kanamycin master standard’’ means a (9) Bacitracin The term ‘‘bacitracin specific lot of kanamycin designated master standard’’ means a specific lot by the Commissioner as the standard of of bacitracin that is designated by the comparison in determining the potency Commissioner as the standard of com- of the kanamycin working standard. parison in determining the potency of (19) Neomycin. The term ‘‘neomycin the bacitracin working standard. master standard’’ means a specific lot (10) [Reserved] of neomycin designated by the Com- (11) Amphotericin. The term missioner as the standard of compari- ‘‘amphotericin A master standard’’ son in determining the potency of the means a specific lot of amphotericin A neomycin working standard. designated by the Commissioner as the (20) Novobiocin. The term ‘‘novobiocin standard of comparison in determining master standard’’ means a specific lot the potency of the amphotericin A of novobiocin designated by the Com- working standard. The term missioner as the standard of compari- ‘‘amphotericin B master standard’’ son in determining the potency of the means a specific lot of amphotericin B novobiocin working standard. designated by the Commissioner as the (21) Nystatin. The term ‘‘nystatin standard of comparison in determining master standard’’ means a specific lot the potency of the amphotericin B nystatin designated by the Commis- working standard. sioner as the standard of comparison in (12) Colistin. The term ‘‘colistin mas- determining the potency of the nys- ter standard’’ means a specific lot of tatin working standard. colistin designated by the Commis- (22) Oleandomycin. The term sioner as the standard of comparison in ‘‘oleandomycin master standard’’ determining the potency of the colistin means a specific lot of oleandomycin working standard. designated by the Commissioner as the

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standard of comparison in determining (33) Cephalothin. The term the potency of the oleandomycin work- ‘‘cephalothin master standard’’ means ing standard. a specific lot of cephalothin designated (23) Oxytetracycline. The term ‘‘oxy- by the Commissioner as the standard of tetracycline master standard’’ means a comparison in determining the potency specific lot of oxytetracycline des- of the cephalothin working standard. ignated by the Commissioner as the (34) Lincomycin. The term ‘‘linco- standard of comparison in determining mycin master standard’’ means a spe- the potency of the oxytetracycline cific lot of lincomycin designated by working standard. the Commissioner as the standard of (24) Paromomycin. The term comparison in determining the potency ‘‘paromomycin master standard’’ of the lincomycin working standard. means a specific lot of paromomycin (35) Methacycline. The term designated by the Commissioner as the ‘‘methacycline master standard’’ standard of comparison in determining means a specific lot of methacycline the potency of the paromomycin work- designated by the Commissioner as the ing standard. standard of comparison in determining (25) Polymyxin B. The term the potency of the methacycline work- ‘‘polymyxin B master standard’’ means ing standard. a specific lot of polymyxin B des- (36) Doxycycline. The term ignated by the Commissioner as the ‘‘doxycycline master standard’’ means α standard of comparison in determining a specific lot of -6- the potency of the polymyxin B work- deoxyoxytetracycline designated by ing standard. the Commissioner as the standard of comparison in determining the potency (26) [Reserved] of the doxycycline working standard. (27) Vancomycin. The term (37) Cephaloridine. The term ‘‘vancomycin master standard’’ means ‘‘cephaloridine master standard’’ a specific lot of vancomycin designated means a specific lot of cephaloridine by the Commissioner as the standard of that is designated by the Commissioner comparison in determining the potency as the standard of comparison in deter- of the vancomycin working standard. mining the potency of the (28) [Reserved] cephaloridine working standard. (29) Troleandomycin. The term (38) Plicamycin. The term ‘‘troleandomycin master standard’’ ‘‘plicamycin master standard’’ means a means a specific lot of troleandomycin specific lot of plicamycin designated by designated by the Commissioner as the the Commissioner as the standard of standard of comparison in determiing comparison in determining the potency the potency of the troleandomycin of the plicamycin working standard. working standard. (39) Clindamycin. The term (30) Gentamicin. The term ‘‘clindamycin master standard’’ means ‘‘gentamicin master standard’’ means a a specific lot of clindamycin designated specific lot of gentamicin designated by the Commissioner as the standard of by the Commissioner as the standard of comparison in determining the potency comparison in determining the potency of the clindamycin working standard. of the gentamicin working standard. (40) Cephaloglycin. The term (31) Dactinomycin. The term ‘‘cephaloglycin master standard’’ ‘‘dactinomycin master standard’’ means a specific lot of cephaloglycin means a specific lot of dactinomycin designated by the Commissioner as the designated by the Commissioner as the standard of comparison in determining standard of comparison in determining the potency of the cephaloglycin work- the potency of the dactinomycin work- ing standard. ing standard. (41) Carbenicillin. The term (32) Candicidin. The term ‘‘candicidin ‘‘carbenicillin master standard’’ means master standard’’ means a specific lot a specific lot of carbenicillin des- of candicidin that is designated by the ignated by the Commissioner as the Commissioner as the standard of com- standard of comparison in determining parison in determining the potency of the potency of the carbenicillin work- the candicidin working standard. ing standard.

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(42) Cephalexin. The term ‘‘cephalexin of cefazolin that is designated by the master standard’’ means a specific lot Commissioner as the standard of com- of cephalexin that is designated by the parison in determining the potency of Commissioner as the standard of com- the cefazolin working standard. parison in determining the potency of (52) Mitomycin. The term ‘‘mitomycin the cephalexin working standard. master standard’’ means a specific lot (43) [Reserved] of crystalline mitomycin that is des- (44) Capreomycin. The term ignated by the Commissioner as the ‘‘capreomycin master standard’’ means standard of comparison in determining a specific lot of capreomycin des- the potency of the mitomycin working ignated by the Commissioner as the standard. standard of comparison in determining (53) Amoxicillin. The term the potency of the capreomycin work- ‘‘amoxicillin master standard’’ means a ing standard. specific lot of amoxicillin that is des- (45) Rifampin. The term ‘‘rifampin ignated by the Commissioner as the master standard’’ means a specific lot standard of comparison in determining of rifampin designated by the Commis- the potency of the amoxicillin working sioner as the standard of comparison in standard. determining the potency of the (54) [Reserved] rifampin working standard. (55) Cephradine. The term (46) Minocycline. The term ‘‘cephradine master standard’’ means a ‘‘minocycline master standard’’ means specific lot of cephradine that is des- a specific lot of minocycline designated ignated by the Commissioner as the by the Commissioner as the standard of standard of comparison in determining comparison in determining the potency the potency of the cephradine working of the minocycline working standard. standard. (47) Spectinomycin. The term (56) Doxorubicin. The term ‘‘spectinomycin master standard’’ ‘‘doxorubicin master standard’’ means means a specific lot of spectinomycin a specific lot of crystalline doxorubicin designated by the Commissioner as the that is designated by the Commissioner standard of comparison in determining as the standard of comparison in deter- the potency of the spectinomycin mining the potency of the doxorubicin working standard. working standard. (48) Clindamycin palmitate hydro- (57) Bleomycin. The term ‘‘bleomycin chloride. The term ‘‘clindamycin master standard’’ means a specific lot palmitate hydrochloride master stand- of bleomycin designated by the Com- ard’’ means a specific lot of missioner as the standard of compari- clindamycin palmitate hydrochloride son in determining the potency of the designated by the Commissioner as the bleomycin working standard. standard of comparison in determining (58) Tobramycin. The term the potency of the clindamycin ‘‘tobramycin master standard’’ means palmitate hydrochloride working a specific lot of tobramycin designated standard. by the Commissioner as the standard of (49) Carbenicillin indanyl. The term comparison in determining the potency ‘‘carbenicillin indanyl master stand- of the tobramycin working standard. ard’’ means a specific lot of (59) Amikacin. The term ‘‘amikacin carbenicillin indanyl designated by the master standard’’ means a specific lot Commissioner as the standard of com- of amikacin designated by the Commis- parison in determining the potency of sioner as the standard of comparison in the carbenicillin indanyl working determining the potency of the standard. amikacin working standard. (50) Cephapirin. The term ‘‘cephapirin (60) Vidarabine. The term ‘‘vidarabine master standard’’ means a specific lot master standard’’ means a specific lot of cephapirin that is designated by the of vidarabine that is designated by the Commissioner as the standard of com- Commissioner as the standard of com- parison in determining the potency of parison in determining the potency of the cephapirin working standard. the vidarabine working standard. (51) Cefazolin. The term ‘‘cefazolin (61) Ticarcillin. The term ‘‘ticarcillin master standard’’ means a specific lot master standard’’ means a specific lot

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of ticarcillin designated by the Com- the potency of the meclocycline work- missioner as the standard of compari- ing standard. son in determining the potency of the (71) Cefotaxime. The term ‘‘cefotaxime ticarcillin working standard. master standard’’ means a specific lot (62) Cefadroxil. The term ‘‘cefadroxil of cefotaxime that is designated by the master standard’’ means a specific lot Commissioner as the standard of com- of cefadroxil that is designated by the parison in determining the potency of Commissioner as the standard of com- the cefotaxime working standard. parison in determining the potency of (72) Mezlocillin. The term ‘‘mezlocillin the cefadroxil working standard. master standard’’ means a specific lot (63) Natamycin. The term ‘‘natamycin of mezlocillin that is designated by the master standard’’ means a specific lot Commissioner as the standard of com- of natamycin designated by the Com- parison in determining the potency of missioner as the standard of compari- the mezlocillin working standard. son in determining the potency of the (73) Moxalactam. The term natamycin working standard. ‘‘moxalactam master standard’’ means (64) Cefoxitin. The term ‘‘cefoxitin a specific lot of moxalactam that is master standard’’ means a specific lot designated by the Commissioner as the of cefoxitin that is designated by the standard of comparison in determining Commissioner as the standard of com- the potency of the moxalactam work- parison in determining the potency of ing standard. the cefoxitin working standard. (74) Piperacillin. The term (65) Cefamandole. The term ‘‘piperacillin master standard’’ means ‘‘cefamandole master standard’’ means a specific lot of piperacillin that is des- a specific lot of cefamandole that is ignated by the Commissioner as the designated by the Commissioner as the standard of comparison in determining standard of comparison in determining the potency of the piperacillin working the potency of the cefamandole work- standard. ing standard. (75) Azlocillin. The term ‘‘azlocillin (66) Cefaclor. The term ‘‘cefaclor mas- master standard’’ means a specific lot ter standard’’ means a specific lot of of azlocillin that is designated by the cefaclor that is designated by the Com- Commissioner as the standard of com- missioner as the standard of compari- parison in determining the potency of son in determining the potency of the the azlocillin working standard. cefaclor working standard. (76) Cefoperazone. The term (67) Cyclacillin. The term ‘‘cyclacillin ‘‘cefoperazone master standard’’ means master standard’’ means a specific lot a specific lot of cefoperazone that is of cyclacillin that is designated by the designated by the Commissioner as the Commissioner as the standard of com- standard of comparison in determining parison in determining the potency of the potency of the cefoperazone work- the cyclacillin working standard. ing standard. (68) Daunorubicin. The term (77) Netilmicin. The term ‘‘netilmicin ‘‘daunorubicin master standard’’ means master standard’’ means a specific lot a specific lot of daunorubicin that is of netilmicin that is designated by the designated by the Commissioner as the Commissioner as the standard of com- standard of comparison in determining parison in determining the potency of the potency of the daunorubicin work- the netilmicin working standard. ing standard. (78) Cefuroxime. The term (69) Sisomicin. The term ‘‘sisomicin ‘‘cefuroxime master standard’’ means a master standard’’ means a specific lot specific lot of cefuroxime that is des- of sisomicin that is designated by the ignated by the Commissioner as the Commissioner as the standard of com- standard of comparison in determining parison in determining the potency of the potency of the cefuroxime working the sisomicin working standard. standard. (70) Meclocycline. The term (79) Ceftizoxime. The term ‘‘meclocycline master standard’’ means ‘‘ceftizoxime master standard’’ means a specific lot of meclocycline that is a specific lot of ceftizoxime that is des- designated by the Commissioner as the ignated by the Commissioner as the standard of comparison in determining standard of comparison in determining

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the potency of the ceftizoxime working Commissioner as the standard of com- standard. parison in determining the potency of (80) Cyclosporine. The term the cefotetan working standard. ‘‘cyclosporine master standard’’ means (89) Aztreonam. The term ‘‘aztreonam a specific lot of cyclosporine that is master standard’’ means a specific lot designated by the Commissioner as the of aztreonam that is designated by the standard of comparison in determining Commissioner as the standard of com- the potency of the cyclosporine work- parison in determining the potency of ing standard. the aztreonam working standard. (81) Ceforanide. The term ‘‘ceforanide (90) Sulbactam. The term ‘‘sulbactam master standard’’ means a specific lot master standard’’ means a specific lot of ceforanide that is designated by the of sulbactam that is designated by the Commissioner as the standard of com- Commissioner as the standard of com- parison in determining the potency of parison in determining the potency of the ceforanide working standard. the sulbactam working standard. (82) Cefonicid. The term ‘‘cefonicid (91) Cefuroxime axetil. The term master standard’’ means a specific lot ‘‘cefuroxime axetil master standard’’ of cefonicid that is designated by the means a specific lot of cefuroxime Commissioner as the standard of com- axetil that is designated by the Com- parison in determining the potency of missioner as the standard of compari- the cefonicid working standard. son in determining the potency of the (83) Clavulanic acid. The term cefuroxime axetil working standard. ‘‘clavulanic acid master standard’’ means a specific lot of clavulanic acid (92) Cefmenoxime. The term or a salt thereof that is designated by ‘‘cefmenoxime master standard’’ means the Commissioner as the standard of a specific lot of cefmenoxime that is comparison in determining the potency designated by the Commissioner as the of the clavulanic acid working stand- standard of comparison in determining ard. the potency of the cefmenoxime work- ing standard. (84) Amdinocillin. The term ‘‘amdinocillin master standard’’ means (93) Cefixime. The term ‘‘cefixime a specific lot of amdinocillin that is master standard’’ means a specific lot designated by the Commissioner as the of cefixime that is designated by the standard of comparison in determining Commissioner as the standard of com- the potency of the amdinocillin work- parison in determining the potency of ing standard. the cefixime working standard. (85) Ceftriaxone. The term (94) Cefotiam. The term ‘‘cefotiam ‘‘ceftriaxone master standard’’ means a master standard’’ means a specific lot specific lot of ceftriaxone that is des- of cefotiam that is designed by the ignated by the Commissioner as the Commissioner as the standard of com- standard of comparison in determining parison in determining the potency of the potency of the ceftriaxone working the cefotiam working standard. standard. (95) Clindamycin phosphate. The term (86) Ceftazidime. The term ‘‘clindamycin phosphate master stand- ‘‘ceftazidime master standard’’ means ard’’ means a specific lot of a specific lot of ceftazidime that is des- clindamycin phosphate that is designed ignated by the Commissioner as the by the Commissioner as the standard standard of comparison in determining for comparison in determining the po- the potency of the ceftazidime working tency of the clindamycin phosphate standard. standard. (87) Imipenem. The term ‘‘imipenem (96) Mupirocin. The term ‘‘mupirocin master standard’’ means a specific lot master standard’’ means a specific lot of imipenem that is designated by the of mupirocin or a salt thereof that is Commissioner as the standard of com- designated by the Commissioner as the parison in determining the potency of standard of comparison in determining the imipenem working standard. the potency of the mupirocin working (88) Cefotetan. The term ‘‘cefotetan standard. master standard’’ means a specific lot (97) Cefmetazole. The term of cefotetan that is designated by the ‘‘cefmetazole master standard’’ means

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a specific lot of cefmetazole that is des- the potency of the cefpodoxime ignated by the Commissioner as the proxetil working standard. standard of comparison in determining (b) Working standards. The potency or the potency of the cefmetazole working purity of each preparation has been de- standard. termined by comparison with its mas- (98) Cefpiramide. The term ter standard , and each has been des- ‘‘cefpiramide master standard’’ means ignated by the Commissioner as work- a specific lot of cefpiramide that is des- ing standards for use in determining ignated by the Commissioner as the the potency or purity of antibiotic sub- standard of comparison in determining stances subject to the regulations in the potency of the cefpiramide working this chapter.Unless otherwise noted, standard. the working standard and the U.S.P. (99) Clarithromycin. The term reference standard for the antibiotic ‘‘clarithromycin master standard’’ drug named are identical. means a specific lot of clarithromycin (1) Penicillin. (i) The term ‘‘penicillin that is designated by the Commissioner G working standard’’ means a specific as the standard of comparison in deter- lot of a homogeneous preparation of mining the potency of the penicillin G. clarithromycin working standard. (ii) [Reserved] (100) Azithromycin. The term (iii) The term ‘‘penicillin V working ‘‘azithromycin master standard’’ standard’’ means a specific lot of a ho- means a specific lot of azithromycin mogeneous preparation of penicillin V. that is designated by the Commissioner (iv) [Reserved] as the standard of comparison in deter- (v) The term ‘‘methicillin working mining the potency of the standard’’ means a specific lot of a ho- azithromycin working standard. mogeneous preparation of methicillin. (101) . The term ‘‘cefprozil Cefprozil (vi) The term ‘‘oxacillin working master standard’’ means a specific lot standard’’ means a specific lot of a ho- of the (Z) isomer of cefprozil and a spe- mogeneous preparation of oxacillin. cific lot of the (E) isomer of cefprozil (vii) The term ‘‘ampicillin working that are designated by the Commis- standard’’ means a specific lot of a ho- sioner as the standard of comparison in mogeneous preparation of ampicillin. determining the potency of the cefprozil working standard. (viii) The term ‘‘nafcillin working standard’’ means a specific lot of a ho- (102) Idarubicin. The term ‘‘idarubicin master standard’’ means a specific lot mogeneous preparation of nafcillin. of idarubicin that is designated by the (ix) The term ‘‘cloxacillin working Commissioner as the standard of com- standard’’ means a specific lot of a ho- parison in determining the potency of mogeneous preparation of cloxacillin. the idarubicin working standard. (x) The term ‘‘penicillin G procaine (103) Loracarbef. The term ‘‘loracarbef working standard’’ means a specific lot master standard’’ means a specific lot of a homogeneous preparation of peni- of loracarbef that is designated by the cillin G procaine. Commissioner as the standard of com- (xi) The term ‘‘dicloxacillin working parison in determining the potency of standard’’ means a specific lot of a ho- the loracarbef working standard. mogeneous preparation of dicloxacillin. (104) Rifabutin. The term ‘‘rifabutin (xii) The term ‘‘bacampicillin hydro- master standard’’ means a specific lot chloride working standard’’ means a of rifabutin that is designated by the specific lot of a homogeneous prepara- Commissioner as the standard of com- tion of bacampicillin hydrochloride. parison in determining the potency of (2) Amphotericin A. The term the rifabutin working standard. ‘‘amphotericin A working standard’’ (105) Cefpodoxime proxetil. The term means a specific lot of a homogeneous ‘‘cefpodoxime proxetil master stand- preparation of amphotericin A. ard’’ means a specific lot of the (R) iso- (3) Amphotericin B. The term mer of cefpodoxime proxetil that is ‘‘amphotericin B working standard’’ designated by the Commissioner as the means a specific lot of a homogeneous standard of comparison in determining preparation of amphotericin B.

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(4) Streptomycin. The term ‘‘strepto- a specific lot of a homogeneous prepa- mycin working standard’’ means a spe- ration of kanamycin. cific lot of a homogeneous preparation (20) Neomycin. The term ‘‘neomycin of streptomycin. working standard’’ means a specific lot (5) Dihydrostreptomycin. The term ‘‘di- of a homogeneous preparation of neo- hydrostreptomycin working standard’’ mycin. means a specific lot of a homogeneous (21) Novobiocin. The term ‘‘novobiocin preparation of dihydrostreptomycin. working standard’’ means a specific lot (6) Chlortetracycline. The term of a homogeneous preparation of ‘‘chlortetracycline working standard’’ novobiocin. means a specific lot of a homogeneous (22) Nystatin. The term ‘‘nystatin preparation of chlortetracycline. working standard’’ means a specific lot (7) Demeclocycline. The term of a homogeneous preparation of nys- ‘‘demeclocycline working standard’’ tatin. means a specific lot of a homogeneous preparation of demeclocycline. (23) Oleandomycin. The term (8) Tetracycline. The term ‘‘tetra- ‘‘oleandomycin working standard’’ cycline working standard’’ means a means a specific lot of a homogeneous specific lot of a homogeneous prepara- preparation of oleandomycin. tion of tetracycline. (24) Troleandomycin. The term (9) Rolitetracycline. The term ‘‘troleandomycin working stand- ‘‘rolitetracycline working standard’’ ard’’means a specific lot of a homo- means a specific lot of a homogeneous geneous preparation of preparation of rolitetracycline. troleandomycin. (10) Chloramphenicol. The term (25) Oxytetracycline. The term ‘‘oxy- ‘‘chloramphenicol working standard’’ tetracycline working standard’’ means means a specific lot of a homogeneous a specific lot of a homogeneous prepa- preparation of chloramphenicol. ration of oxytetracycline. (11) Bacitracin. The term ‘‘bacitracin (26) Paromomycin. The term working standard’’ means a specific lot ‘‘paromomycin working standard’’ of a homogeneous preparation of baci- means a specific lot of a homogeneous tracin. preparation of paromomycin. (12) [Reserved] (27) Polymyxin B. The term (13) Colistin. The term ‘‘colistin work- ‘‘polymyxin B working standard’’ ing standard’’ means a specific lot of a means a specific lot of a homogeneous homogeneous preparation of colistin. preparation of polymyxin B. (14) Colistimethate. The term (28) Vancomycin. The term ‘‘colistimethate working standard’’ ‘‘vancomycin working standard’’ means a specific lot of a homogeneous means a specific lot of a homogeneous preparation of colistimethate. preparation of vancomycin. (15) Cycloserine. The term ‘‘cyclo- (29) [Reserved] serine working standard’’ means a spe- (30) Gentamicin. The term cific lot of a homogeneous preparation of cycloserine. ‘‘gentamicin working standard’’ means a specific lot of a homogeneous prepa- (16) Erythromycin. The term ‘‘erythro- mycin working standard’’ means a spe- ration of gentamicin. cific lot of a homogeneous preparation (31) Dactinomycin. The term of erythromycin. ‘‘dactinomycin working standard’’ (17) Gramicidin. The term ‘‘gramicidin means a specific lot of a homogeneous working standard’’ means a specific lot preparation of dactinomycin. of a homogeneous preparation of gram- (32) Candicidin. The term ‘‘candicidin icidin. working standard’’ means a specific lot (18) Griseofulvin. The term ‘‘griseo- of a homogeneous preparation of fulvin working standard’’ means a spe- candicidin. cific lot of a homogeneous preparation (33) Cephalothin. The term of griseofulvin. ‘‘cephalothin working standard’’ means (19) Kanamycin. The term a specific lot of a homogeneous prepa- ‘‘kanamycin working standard’’ means ration of cephalothin.

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(34) Lincomycin. The term ‘‘linco- (49) Carbenicillin indanyl. The term mycin working standard’’ means a spe- ‘‘carbenicillin indanyl working stand- cific lot of a homogeneous preparation ard’’ means a specific lot of a homo- of lincomycin. geneous preparation of carbenicillin (35) Methacycline. The term indanyl. ‘‘methacycline working standard’’ (50) Cephapirin. The term ‘‘cephapirin means a specific lot of homogeneous working standard’’ means a specific lot preparation of methacycline. of a homogeneous preparation of (36) Doxycycline. The term cephapirin. ‘‘doxycycline working standard’’ means (51) Cefazolin. The term ‘‘cefazolin a specific lot of homogeneous prepara- working standard’’ means a specific lot tion of α-6-deoxyoxytetracycline. of a homogeneous preparation of (37) Cephaloridine. The term cefazolin. ‘‘cephaloridine working standard’’ (52) Mitomycin. The term ‘‘mitomycin means a specific lot of homogeneous working standard’’ means a specific lot preparation of cephaloridine. of a homogeneous preparation of (38) Plicamycin. The term mitomycin. ‘‘plicamycin working standard’’ means (53) Amoxicillin. The term a specific lot of a homogeneous prepa- ‘‘amoxicillin working standard’’ means ration of plicamycin. a specific lot of a homogeneous prepa- (39) Clindamycin. The term ration of amoxicillin. ‘‘clindamycin working standard’’ (54) [Reserved] means a specific lot of a homogeneous (55) Cephradine. The term preparation of clindamycin. ‘‘cephradine working standard’’ means (40) Cephaloglycin. The term a specific lot of a homogeneous prepa- ‘‘cephaloglycin working standard’’ ration of cephradine. means a specific lot of homogeneous (56) Doxorubicin. The term preparation of cephaloglycin. ‘‘doxorubicin working standard’’ means (41) Carbenicillin. The term a specific lot of a homogeneous prepa- ‘‘carbenicillin working standard’’ ration of doxorubicin. means a specific lot of homogeneous preparation of carbenicillin. (57) Bleomycin. The term ‘‘bleomycin (42) Cephalexin. The term ‘‘cephalexin working standard’’ means a specific lot working standard’’ means a specific lot of a homogeneous preparation of of a homogeneous preparation of bleomycin. cephalexin. (58) Tobramycin. The term (43) [Reserved] ‘‘tobramycin working standard’’ means (44) Capreomycin. The term a specific lot of a homogeneous prepa- ‘‘capreomycin working standard’’ ration of tobramycin. means a specific lot of a homogeneous (59) Amikacin. The term ‘‘amikacin preparation of capreomycin. working standard’’ means a specific lot (45) Rifampin. The term ‘‘rifampin of a homogeneous preparation of working standard’’ means a specific lot amikacin. of a homogeneous preparation of (60) Vidarabine. The term ‘‘vidarabine rifampin. working standard’’ means a specific lot (46) Minocycline. The term of a homogeneous preparation of ‘‘minocycline working standard’’ vidarabine. means a specific lot of a homogeneous (61) Ticarcillin. The term ‘‘ticarcillin preparation of minocycline. working standard’’ means a specific lot (47) Spectinomycin. The term of a homogeneous preparation of ‘‘spectinomycin working standard’’ ticarcillin. means a specific lot of a homogeneous (62) Cefadroxil. The term ‘‘cefadroxil preparation of spectinomycin. working standard’’ means a specific lot (48) Clindamycin palmitate hydro- of a homogeneous preparation of chloride. The term ‘‘clindamycin cefadroxil. palmitate hydrochloride working (63) Natamycin. The term ‘‘natamycin standard’’ means a specific lot of a ho- working standard’’ means a specific lot mogeneous preparation of clindamycin of a homogeneous preparation of palmitate hydrochloride. natamycin.

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(64) Cefoxitin. The term ‘‘cefoxitin a specific lot of a homogeneous prepa- working standard’’ means a specific lot ration of cefuroxime. of a homogeneous preparation of (79) Ceftizoxe. The term ‘‘ceftizoxime cefoxitin. working standard’’ means a specific lot (65) Cefamandole. The term of a homogeneous preparation of ‘‘cefamandole working standard’’ ceftizoxime. means a specific lot of a homogeneous (80) 4-Epitetracycline. The term ‘‘4- preparation of cefamandole. epitetracycline working standard’’ (66) Cefaclor. The term ‘‘cefaclor means a specific lot of a homogeneous working standard’’ means a specific lot preparation of 4-epitetracycline. of a homogeneous preparation of (81) Chloramphenicol palmitate. The cefaclor. term ‘‘chloramphenicol palmitate (67) Cyclacillin. The term ‘‘cyclacillin working standard’’ means a specific lot working standard’’ means a specific lot of a homogeneous preparation of chlor- of a homogeneous preparation of amphenicol palmitate. cyclacillin. (82) Cyclosporine. The term (68) Daunorubicin. The term ‘‘cyclosporine working standard’’ ‘‘daunorubicin working standard’’ means a specific lot of a homogeneous means a specific lot of a homogeneous preparation of cyclosporine. preparation of daunorubicin. (83) Ceforanide. The term ‘‘ceforanide (69) Sisomicin. The term ‘‘sisomicin working standard’’ means a specific lot working standard’’ means a specific lot of a homogeneous preparation of of a homogeneous preparation of ceforanide. sisomicin. (84) Cefonicid. The term ‘‘cefonicid (70) Meclocycline. The term working standard’’ means a specific lot ‘‘meclocycline working standard’’ of a homogeneous preparation of means a specific lot of a homogeneous cefonicid. preparation of meclocycline. (85) Clavulanic acid. The term (71) Cefotaxime. The term ‘‘cefotaxime ‘‘clavulanic acid working standard’’ working standard’’ means a specific lot means a specific lot of a homogeneous of a homogeneous preparation of preparation of clavulanic acid or a salt cefotaxime. thereof. (72) Mezlocillin. The term ‘‘mezlocillin (86) Amdinocillin. The term working standard’’ means a specific lot ‘‘amdinocillin working standard’’ of a homogeneous preparation of means a specific lot of a homogeneous mezlocillin. preparation of amdinocillin. (73) Moxalactam. The term (87) Ceftriaxone. The term ‘‘moxalactam working standard’’ ‘‘ceftriaxone working standard’’ means means a specific lot of a homogeneous a specific lot of a homogeneous prepa- preparation of moxalactam. ration of ceftriaxone. (74) Piperacillin. The term (88) Ceftazidime. The term ‘‘piperacillin working standard’’ means ‘‘ceftazidime working standard’’ means a specific lot of a homogeneous prepa- a specific lot of a homogeneous prepa- ration of piperacillin. ration of ceftazidime. (75) Azlocillin. The term ‘‘azlocillin (89) Imipenem. The term ‘‘imipenem working standard’’ means a specific lot working standard’’ means a specific lot of a homogeneous preparation of of a homogeneous preparation of azlocillin. imipenem. (76) Cefoperazone. The term (90) Cefotetan. The term ‘‘cefotetan ‘‘cefoperazone working standard’’ working standard’’ means a specific lot means a specific lot of a homogeneous of a homogeneous preparation of preparation of cefoperazone. cefotetan. (77) Netilmicin. The term ‘‘netimicin (91) Aztreonam. The term ‘‘aztreonam working standard’’ means a specific lot working standard’’ means a specific lot of a homogeneous preparation of of a homogeneous preparation of netilmicin. aztreonam. (78) Cefuroxime. The term (92) Sulbactam. The term ‘‘sulbactam ‘‘cefuroxime working standard’’ means working standard’’ means a specific lot

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of a homogeneous preparation of (106) Rifabutin. The term ‘‘rifabutin sulbactam. working standard’’ means a specific lot (93) Cefuroxime axetil. The term of a homogeneous preparation of ‘‘cefuroxime axetil working standard’’ rifabutin. means a specific lot of a homogeneous (107) Cefpodoxime proxetil. The term preparation of cefuroxime axetil. ‘‘cefpodoxime proxetil working stand- (94) Cefmenoxime. The term ard’’ means a specific lot of a homo- ‘‘cefmenoxime working standard’’ geneous preparation of cefpodoxime means a specific lot of a homogeneous proxetil. preparation of cefmenoxime. [39 FR 18925, May 30, 1974] (95) Cefixime. The term ‘‘cefixime EDITORIAL NOTE: For FEDERAL REGISTER ci- working standard’’ means a specific lot tations affecting § 430.5, see the List of CFR of a homogeneous preparation of Sections Affected appearing in the Finding cefixime. Aids section of this volume. (96) Cefotiam. The term ‘‘cefotiam working standard’’ means a specific lot § 430.6 Definitions of the terms ‘‘unit’’ of a homogenous preparation of and ‘‘microgram’’ as applied to anti- cefotiam. biotic substances. (97) Clindamycin phosphate. The term Unless it has been otherwise specified ‘‘clindamycin phosphate working in the individual definitions in this standard’’ means a specific lot of a ho- section, the activity assigned to each mogenous preparation of clindamycin ‘‘unit’’ or ‘‘microgram’’ is equivalent phosphate. to an International Unit, if such has (98) Mupirocin. The term ‘‘mupirocin been defined by the World Health Orga- working standard’’ means a specific lot nization. of a homogeneous preparation of (a) ‘‘Unit’’—(1) Penicillin—(i) Penicillin mupirocin or a salt thereof. G. The term ‘‘unit’’ applies to penicil- (99) Cefmetazole. The term lin G means the penicillin activity (po- ‘‘cefmetazole working standard’’ means tency) contained in 0.600 microgram of a specific lot of a homogeneous prepa- the penicillin G master standard. (ii) [Reserved] ration of cefmetazole. (iii) Penicillin V. The term ‘‘unit’’ ap- (100) Cefpiramide. The term plied to penicillin V means the penicil- ‘‘cefpiramide working standard’’ means lin activity (potency) contained in 0.590 a specific lot of a homogeneous prepa- microgram of the penicillin V master ration of cefpiramide. standard. (101) Clarithromycin. The term (2) Bacitracin. The term ‘‘unit’’ ap- ‘‘clarithromycin working standard’’ plied to bacitracin means a bacitracin means a specific lot of a homogeneous activity (potency) contained in 13.51 preparation of clarithromycin. micrograms of the bacitracin master (102) Azithromycin. The term standard, except that when the activ- ‘‘azithromycin working standard’’ ity (potency) of bacitracin is expressed means a specific lot of a homogeneous in terms of its weight, as in the feed preparation of azithromycin. and drinking water of animals, 1 gram (103) Cefprozil. The term ‘‘cefprozil of activity is equivalent to 42,000 units. (Z) working standard’’ means a specific (3) Nystatin. The term ‘‘unit’’ applied lot of a homogeneous preparation of to nystatin means the nystatin activ- cefprozil (Z). The term ‘‘cefprozil (E) ity (potency) contained in 0.2817 working standard’’ means a specific lot microgram of the nystatin master of a homogeneous preparation of standard when dried for 2 hours at 40° cefprozil (E). C. and a pressure of 5 millimeters or (104) Idarubicin. The term ‘‘idarubicin less. working standard’’ means a specific lot (4) Polymyxin B. The term ‘‘unit’’ ap- of a homogeneous preparation of plied to polymyxin B means the idarubicin. polymyxin activity (potency) con- (105) Loracarbef. The term ‘‘loracarbef tained in 0.1274 microgram of the working standard’’ means a specific lot polymyxin B master standard when of a homogeneous preparation of dried for 3 hours at 60° C. and a pres- loracarbef. sure of 5 millimeters or less.

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(5) Bleomycin. The term ‘‘unit’’ ap- (9) Oxacillin. The term ‘‘microgram’’ plied to bleomycin means the applied to oxacillin means the oxacillin bleomycin activity (potency) contained activity (potency) contained in 1.111 in 0.637 milligram of the bleomycin micrograms of the oxacillin master master standard. standard. (b) ‘‘Microgram’’—(1) Streptomycin. (10) [Reserved] The term ‘‘microgram’’ applied to (11) Amphotericin A. The term streptomycin means the streptomycin ‘‘microgram’’ applied to amphotericin activity (potency) contained in 1.250 A means the amphotericin A activity micrograms of the streptomycin mas- (potency) contained in 1.0 microgram ter standard after it is dried for 3 hours of the amphotericin A master standard at 60° C. and a pressure of 5 millimeters when dried for 3 hours at 60° C. and a or less. pressure of 5 millimeters or less. (2) Dihydrostreptomycin. The term (12) Amphotericin B. The term ‘‘microgram’’ applied to dihydro- ‘‘microgram’’ applied to amphotericin streptomycin means the dihydro- B means the amphotericin B activity streptomycin activity (potency) con- (potency) contained in 1.014 tained in 1.25 micrograms of the dihy- micrograms of the amphotericin B drostreptomycin master standard after master standard when dried for 3 hours it is dried for 4 hours at 100° C. and a at 60° C. and a pressure of 5 millimeters pressure of 50 microns or less. or less. (3) Chlortetracycline. The term (13) Colistin. The term ‘‘microgram’’ ‘‘microgram’’ applied to applied to colistin means the colistin chlortetracycline means the base activity (potency) contained in chlortetracycline activity (potency) 1.495 micrograms of the colistin master contained in 1.0 microgram of the standard when dried for 3 hours at 60° chlortetracycline master standard. C. and a pressure of 5 millimeters or (4) Demeclocycline. The term less. The numerical value of a ‘‘microgram’’ applied to microgram of colistin is not equivalent demeclocycline means the to the International Unit. demeclocycline activity (potency) con- (14) Colistimethate. The term tained in 1.0 microgram of the ‘‘microgram’’ applied to colistimethate demeclocycline master standard after means the activity (potency) cal- it is dried for 3 hours at 60° C. and a culated as colistin base that is con- pressure of 5 millimeters or less. tained in 1.938 micrograms of the (5) Tetracycline. The term colistimethate master standard when ‘‘microgram’’ applied to tetracycline dried for 3 hours at 60° C. and a pres- means the tetracycline activity (po- sure of 5 millimeters or less. The nu- tency) contained in 1.0 microgram of merical value of a microgram of tetracycline master standard. colistimethate is not equivalent to the (6) Rolitetracycline. The term International Unit. ‘‘microgram’’ applied to (15) Cycloserine. The term rolitetracycline means the ‘‘microgram’’ applied to cycloserine rolitetracycline activity (potency) con- means the cycloserine activity (po- tained in 1.0 microgram of the tency) contained in 1.0 microgram of rolitetracycline master standard when the cycloserine master standard when dried for 3 hours at 60° C. and a pres- dried for 3 hours at 60° C. and a pres- sure of 5 millimeters or less. sure of 5 millimeters or less. (7) Chloramphenicol. The term (16) Erythromycin. The term ‘‘microgram’’ applied to chlorampheni- ‘‘microgram’’ applied to erythromycin col means the chloramphenicol activ- means the erythromycin base activity ity (potency) contained in 1.0 (potency) contained in 1.02 micrograms microgram of the chloramphenicol of the erythromycin master standard master standard. when dried for 3 hours at 60° C. and a (8) Methicillin. The term pressure of 5 millimeters or less. ‘‘microgram’’ applied to methicillin (17) Gramicidin. The term means the methicillin activity (po- ‘‘microgram’’ applied to gramicidin tency) contained in 1.105 micrograms of means the gramicidin activity (po- the methicillin master standard. tency) contained in 1.0 microgram of

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the gramicidin master standard when at 60° C. and a pressure of 5 millimeters dried for 3 hours at 60° C. and a pres- or less. sure of 5 millimeters or less. (27) Vancomycin. The term (18) Griseofulvin. The term ‘‘microgram’’ applied to vancomycin ‘‘microgram’’ applied to griseofulvin means the vancomycin base activity means the griseofulvin activity (po- (potency) contained in 1.25 micrograms tency) contained in 1.0 microgram of of the vancomycin master standard. the griseofulvin master standard. (28) [Reserved] (19) Kanamycin. The term (29) Ampicillin. The term ‘‘microgram’’ applied to kanamycin ‘‘microgram’’ applied to ampicillin means the kanamycin base activity means the ampicillin activity (po- (potency) contained in 1.299 tency) contained in 1.1764 micrograms micrograms of the kanamycin master of the ampicillin master standard. standard. (30) Nafcillin. The term ‘‘microgram’’ (20) Neomycin. The term ‘‘microgram’’ applied to nafcillin means the nafcillin applied to neomycin means the neomy- activity (potency) contained in 1.0989 cin base activity (potency) contained micrograms of the nafcillin master in 1.429 micrograms of the neomycin standard. master standard when dried for 3 hours (31) Gentamicin. The term at 60° C. and a pressure of 5 millimeters ‘‘microgram’’ applied to gentamicin or less. means the gentamicin activity (po- (21) Novobiocin. The term tency) contained in 1.56 micrograms of ‘‘microgram’’ applied to novobiocin the gentamicin master standard when means the novobiocin acid activity (po- dried for 3 hours at 110° C. and a pres- tency) contained in 1.033 micrograms of sure of 5 millimeters or less. the novobiocin master standard when (32) Dactinomycin. The term dried for 3 hours at 60° C. and a pres- ‘‘microgram’’ applied to dactinomycin sure of 5 millimeters or less. means the dactinomycin activity (po- (22) Oleandomycin. The term tency) contained in 1.000 microgram of ‘‘microgram’’ applied to oleandomycin the dactinomycin master standard means the oleandomycin base activity when dried for 3 hours at 60° C. and a (potency) contained in 1.176 pressure of 5 millimeters or less. micrograms of the oleandomycin mas- (33) Candicidin. The term ter standard. ‘‘microgram’’ applied to candicidin (23) Troleandomycin. The term means the candicidin activity (po- ‘‘microgram’’ applied to tency) contained in 1.0 microgram of troleandomycin means the activity the candicidin master standard when (potency), calculated as the molecular dried for 3 hours at 40° C. and a pres- equivalent of the oleandomycin base, sure of 5 millimeters or less. contained in 1.2315 micrograms of the (34) Cephalothin. The term troleandomycin master standard. ‘‘microgram’’ applied to cephalothin (24) Oxytetracycline. The means the cephalothin activity (po- ‘‘microgram’’ applied to oxytetra- tency) contained in 1.056 micrograms of cycline means the oxytetracycline base the cephalothin master standard when activity (potency) contained in 1.13 dried for 3 hours at 60° C. and a pres- micrograms of the oxytetracycline sure of 5 millimeters or less. master standard. (35) Lincomycin. The term (25) Paromomycin. The term ‘‘microgram’’ applied to lincomycin ‘‘microgram’’ applied to paromomycin means the lincomycin base activity means the paromomycin activity (po- (potency) contained in 1.156 tency) contained in 1.333 micrograms of micrograms of the lincomycin master the paromomycin master standard standard. when dried for 3 hours at 60° C. and a (36) Cloxacillin. The term pressure of 5 millimeters or less. ‘‘microgram’’ applied to cloxacillin (26) Tyrothricin. The term means the cloxacillin activity (po- ‘‘microgram’’ applied to tyrothricin tency) contained in 1.135 micrograms of means the activity (potency) contained the cloxacillin master standard. in 0.2 microgram of the gramicidin (37) Methacycline. The term master standard when dried for 3 hours ‘‘microgram’’ applied to methacycline

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means the methacycline activity (po- activity (potency) contained in 1.0101 tency) contained in 1.082 micrograms of micrograms of the rifampin master the methacycline master standard standard. when dried for 3 hours at 60° C. and a (49) Minocycline. The term pressure of 5 millimeters or less. ‘‘microgram’’ applied to minocycline (38) Doxycycline. The term means the minocycline activity (po- ‘‘microgram’’ applied to doxycycline tency) contained in 1.1588 micrograms means the doxycycline activity (po- of the minocycline master standard. tency) contained in 1.155 micrograms of (50) Spectinomycin. The term the doxycycline master standard. ‘‘microgram’’ applied to spectinomycin (39) Cephaloridine. The term means the spectinomycin activity (po- ‘‘microgram’’ applied to cephaloridine tency) contained in 1.490 micrograms of means the cephaloridine activity (po- the spectinomycin master standard. tency) contained in 1.00806 micrograms (51) Clindamycin palmitate hydro- of the cephaloridine master standard chloride. The term ‘‘microgram’’ ap- when dried for 3 hours at 60° C. and a plied to clindamycin palmitate hydro- pressure of 5 millimeters or less. chloride means the clindamycin activ- (40) Dicloxacillin. The term ity (potency) contained in 1.661 ‘‘microgram’’ applied to dicloxacillin micrograms of the clindamycin means the dicloxacillin activity (po- palmitate hydrochloride master stand- tency) contained in 1.087 micrograms of ard. the dicloxacillin master standard. (52) Carbenicillin indanyl. The term (41) Plicamycin. The term ‘‘microgram’’ applied to carbenicillin ‘‘microgram’’ applied to plicamycin indanyl means the carbenicillin activ- means the plicamycin activity (po- ity (potency) contained in 1.4514 tency) contained in 1.000 microgram of micrograms of the carbenicillin the plicamycin master standard when indanyl master standard. dried for 4 hours at 25° C. and a pres- (53) Cephapirin. The term sure of 5 millimeters or less. ‘‘microgram’’ applied to cephapirin (42) Clindamycin. The term means the cephapirin activity (po- ‘‘microgram’’ applied to clindamycin tency) contained in 1.0616 micrograms means the clindamycin activity (po- of the cephapirin master standard. tency) contained in 1.139 micrograms of (54) Cefazolin. The term ‘‘microgram’’ the clindamycin master standard. applied to cefazolin means the (43) Cephaloglycin. The term cefazolin activity (potency) contained ‘‘microgram’’ applied to cephaloglycin in 1.005 micrograms of the cefazolin means the cephaloglycin activity (po- master standard. tency) contained in 1.02564 micrograms (55) Mitomycin. The term of the cephaloglycin master standard. ‘‘microgram’’ applied to mitomycin (44) Carbenicillin. The term means the mitomycin activity (po- ‘‘microgram’’ applied to carbenicillin tency) contained in 1.0416 micrograms means the carbenicillin activity (po- of the mitomycin master standard. tency) contained in 1.135 micrograms of (56) Amoxicillin. The term the carbenicillin master standard. ‘‘microgram’’ applied to amoxicillin (45) Cephalexin. The term means the amoxicillin activity (po- ‘‘microgram’’ applied to cephalexin tency) contained in 1.17647 micrograms means the cephalexin activity (po- of the amoxicillin master standard. tency) contained in 1.0707 micrograms (57) [Reserved] of the cephalexin master standard. (58) Cephradine. The term (46) [Reserved] ‘‘microgram’’ applied to cephradine (47) Capreomycin. The term means the cephradine activity (po- ‘‘microgram’’ applied to capreomycin tency) contained in 1.1111 micrograms means the capreomycin activity (po- of the cephradine master standard. tency) contained in 1.0870 micrograms (59) Doxorubicin. The term of the capreomycin master standard ‘‘microgram’’ applied to doxorubicin when dried for 4 hours at 100° C. and a means the activity (potency) cal- pressure of 5 millimeters or less. culated as doxorubicin hydrochloride (48) Rifampin. The term ‘‘microgram’’ contained in 1.0204 micrograms of the applied to rifampin means the rifampin doxorubicin master standard.

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(60) Tobramycin. The term ter standard expressed on an anhydrous ‘‘microgram’’ applied to tobramycin basis. means the tobramycin activity (po- (72) Meclocycline. The term tency) contained in 1.126 micrograms of ‘‘microgram’’ applied to meclocycline the tobramycin master standard. means the meclocycline activity (po- (61) Amikacin. The term ‘‘microgram’’ tency) contained in 1.0493 micrograms applied to amikacin means the of the meclocycline master standard. amikacin activity (potency) contained (73) Cefotaxime. The term in 1.091 micrograms of the amikacin ‘‘microgram’’ applied to cefotaxime master standard. means the cefotaxime activity (po- (62) Vidarabine. The term tency) contained in 1.089 micrograms of ‘‘microgram’’ applied to vidarabine cefotaxime master standard. means the vidarabine activity (po- (74) Mezlocillin. The term tency) contained in 1.0674 micrograms ‘‘microgram’’ applied to mezlocillin of the vidarabine master standard. means the mezlocillin activity (po- (63) Ticarcillin. The term tency) contained in 1.1086 micrograms ‘‘microgram’’ applied to ticarcillin of the mezlocillin master standard. means the ticarcillin activity (po- (75) Moxalactam. The term tency) contained in 1.136 micrograms of ‘‘microgram’’ applied to moxalactam the ticarcillin master standard. means the moxalactam activity (po- (64) Cefadroxil. The term tency) contained in 1.1173 micrograms ‘‘microgram’’ applied to cefadroxil of the moxalactam master standard. means the cefadroxil activity (potency) (76) Piperacillin. The term contained in 1.0537 micrograms of the ‘‘microgram’’ applied to piperacillin cefadroxil master standard. means the piperacillin activity (po- (65) Natamycin. The term tency) contained in 1.0460 micrograms ‘‘microgram’’ applied to natamycin of the piperacillin master standard. means the natamycin activity (po- tency) contained in 1.0846 micrograms (77) Cefoperazone. The term of the natamycin master standard. ‘‘microgram’’ applied to cefoperazone means the cefoperazone activity (po- (66) Cefoxitin. The term ‘‘microgram’’ applied to cefoxitin means the tency) contained in 1.056 micrograms of cefoxitin activity (potency) contained the cefoperazone master standard. in 1.072 micrograms of the cefoxitin (78) Azlocillin. The term ‘‘microgram’’ master standard. applied to azlocillin means the (67) Cefamandole. The term azlocillin activity (potency) contained ‘‘microgram’’ applied to cefamandole in 1.128 micrograms of the azlocillin means the cefamandole activity (po- master standard. tency) contained in 1.1364 micrograms (79) Netilmicin. The term of cefamandole master standard. ‘‘microgram’’ applied to netilmicin (68) Cefaclor. The term ‘‘microgram’’ means the netilmicin activity (po- applied to cefaclor means the cefaclor tency) contained in 1.000 microgram of activity (potency) contained in 1.0493 the netilmicin master standard ex- micrograms of cefaclor master stand- pressed on an anhydrous basis. ard. (80) Cefuroxime. The term (69) Cyclacillin. The term ‘‘microgram’’ applied to cefuroxime ‘‘microgram’’ applied to cyclacillin means the cefuroxime activity (po- means the cyclacillin activity (po- tency) contained in 1.0893 micrograms tency) contained in 1.01 micrograms of of the cefuroxime master standard. the cyclacillin master standard. (81) Ceftizoxime. The term (70) Daunorubicin. The term ‘‘microgram’’ applied to ceftizoxime ‘‘microgram’’ applied to daunorubicin means the ceftizoxime activity (po- means the daunorubicin activity (po- tency) contained in 1.011 micrograms of tency) contained in 1.0965 micrograms the ceftizoxime master standard. of the daunorubicin master standard. (82) Cyclosporine. The term (71) Sisomicin. The term ‘‘microgram’’ ‘‘microgram’’ applied to cyclosporine applied to sisomicin means the means the cyclosporine activity (po- sisomicin activity (potency) contained tency) contained in 1.0173 micrograms in 1.00 microgram of the sisomicin mas- of cyclosporine master standard.

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(83) Ceforanide. The term means the cefmenoxime activity (po- ‘‘microgram’’ applied to ceforanide tency) contained in 1.0482 micrograms means the ceforanide activity (po- of the cefmenoxime master standard. tency) contained in 1.005 micrograms of (95) Cefixime. The term ‘‘microgram’’ the ceforanide master standard. applied to cefixime means the cefixime (84) Cefonicid. The term ‘‘microgram’’ activity (potency) contained in 1.126 applied to cefonicid means the micrograms of the cefixime master cefonicid activity (potency) contained standard. in 1.150 micrograms of the cefonicid (96) Cefotiam. The term ‘‘microgram’’ master standard. applied to cefotiam means the cefotiam (85) Clavulanic acid. The term (potency) contained in 1.144 ‘‘microgram’’ applied to clavulanic micrograms of the cefotiam master acid means the clavulanic acid activity standard. (potency) contained in 1.053 micrograms of clavulanic acid master (97) Clindamycin phosphate. The term standard. ‘‘microgram’’ applied to clindamycin (86) Amdinocillin. The term phosphate means the clindamycin ‘‘microgram’’ applied to amdinocillin phosphate (potency) contained in 1.252 means the amdinocillin activity (po- micrograms of the clindamycin phos- tency) contained in 1.004 micrograms of phate master standard. the amdinocillin master standard. (98) Mupirocin. The term (87) Ceftriaxone. The term ‘‘microgram’’ applied to mupirocin ‘‘microgram’’ applied to ceftriaxone means the activity (potency) cal- means the ceftriaxone activity (po- culated as mupirocin activity (po- tency) contained in 1.19 micrograms of tency) contained in 1.075 micrograms of the ceftriaxone master standard. the mupirocin master standard. (88) Ceftazidime. The term (99) Cefmetazole. The term ‘‘microgram’’ applied to ceftazidime ‘‘microgram’’ applied to cefmetazole means the ceftazidime activity (po- means the cefmetazole (potency) con- tency) contained in 1.1834 micrograms tained in 1.002 micrograms of the of the ceftazidime master standard. cefmetazole master standard. (89) Imipenem. The term ‘‘microgram’’ (100) Cefpiramide. The term applied to imipenem monohydrate ‘‘microgram’’ applied to cefpiramide means the imipenem activity (potency) means the cefpiramide (potency) con- contained in 1.085 micrograms of the tained in 0.994 microgram of the imipenem master standard. cefpiramide master standard. (90) Cefotetan. The term ‘‘microgram’’ (101) Clarithromycin. The term applied to cefotetan means the ‘‘microgram’’ applied to cefotetan activity (potency) contained clarithromycin means the in 1.012 micrograms of the cefotetan clarithromycin (potency) contained in master standard. 1.010 micrograms of the clarithromycin (91) Aztreonam. The term master standard. ‘‘microgram’’ applied to aztreonam (102) Azithromycin. The term means the aztreonam activity (po- ‘‘microgram’’ applied to azithromycin tency) contained in 1.05 micrograms of the aztreonam master standard. means the azithromycin (potency) con- (92) Sulbactam. The term tained in 1.063 micrograms of the ‘‘microgram’’ applied to sulbactam azithromycin master standard. means the sulbactam activity (po- (103) Cefprozil. The term tency) contained in 1.002 micrograms of ‘‘microgram’’ applied to cefprozil (Z) the sulbactam master standard. means the cefprozil (Z) potency con- (93) Cefuroxime axetil. The term tained in 1.060 micrograms of the ‘‘microgram’’ applied to cefuroxime cefprozil (Z) master standard. The term axetil means the cefuroxime activity ‘‘microgram’’ applied to cefprozil (E) (potency) contained in 1.246 means the cefprozil (E) potency con- micrograms of the cefuroxime axetil tained in 1.106 micrograms of the master standard. cefprozil (E) master standard. (94) Cefmenoxime. The term (104) Idarubicin. The term ‘‘microgram’’ applied to cefmenoxime ‘‘microgram’’ applied to idarubicin

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means the idarubicin activity (po- drug’’ or ‘‘no longer a new drug.’’ FDA tency) calculated as idarubicin hydro- revoked those opinions under § 310.100 chloride contained in 1.036 micrograms of this chapter. of the idarubicin master standard. (b) The 1962 amendments amended (105) Loracarbef. The term section 507 of the act to require the ‘‘microgram’’ applied to loracarbef certification, release without certifi- means the loracarbef (potency) con- cation, or exemption from certifi- tained in 1.059 micrograms of the cation, of all antibiotic drugs on the loracarbef master standard. basis of scientific proof of safety and (106) Rifabutin. The term effectiveness. The amendments pro- ‘‘microgram’’ applied to rifabutin vided that FDA implement them for means the rifabutin (potency) con- antibiotic drugs that were marketed on tained in 1.022 micrograms of the April 30, 1963 and were not subject to rifabutin master standard. the certification provisions on that (107) Cefpodoxime proxetil. The term date. FDA is implementing the amend- ‘‘microgram’’ applied to cefpodoxime ments with respect to antibiotic drugs proxetil means the cefpodoxime (po- formerly subject to the new drug provi- tency) contained in 1.304 micrograms of sions of the act through its Drug Effi- the cefpodoxime proxetil master stand- cacy Study Implementation (DESI) ard when dried. program under which the agency is evaluating those antibiotic drugs for [39 FR 18925, May 30, 1974] efficacy. Until FDA completes that EDITORIAL NOTE: For FEDERAL REGISTER ci- evaluation it will permit continued tations affecting § 430.6, see the List of CFR marketing of those antibiotic drugs Sections Affected appearing in the Finding under paragraph (c) of this section. The Aids section of this volume. agency is also implementing the 1962 amendments with respect to antibiotic Subpart B—Antibiotic Drugs Af- drugs formerly not subject to either fected by the Drug Amend- the certification or new drug provi- ments of 1962 sions of the act and the agency is eval- uating those antibiotic drugs for both § 430.10 Certification or release of an- safety and efficacy. Until FDA com- tibiotic drugs affected by the drug pletes that evaluation, it will permit amendments of 1962. continued marketing of those anti- (a) Before the 1962 amendments to it, biotic drugs under paragraph (d) of this the Federal Food, Drug, and Cosmetic section. Act only permitted the Food and Drug (c) Unless exempted from certifi- Administration to provide for the cer- cation, FDA will certify or release an- tification of batches of antibiotic drugs tibiotic drugs which on April 30, 1963 containing penicillin, streptomycin, were the subject of an approved new chlortetracycline, chloramphenicol, or drug application under section 505 of bacitracin, or any derivative of them. the act, under regulations providing for FDA certified those drugs under regu- certification of the drugs. Although the lations promulgated on the basis of sci- initial regulation for each of these entific proof of the drugs’ safety and ef- drugs established under section 507(h) fectiveness. Most drugs containing an of the act was not conditioned upon an antibiotic other than one of those list- affirmative finding of the effectiveness ed were subject to the new drug provi- of the drug, FDA is proceeding under sions of the act, which required that an its DESI program to amend or repeal applicant show that the drug was safe those regulations to provide for certifi- and obtain FDA approval of a new drug cation of those drugs only if they had application before marketing it. An af- been shown to be both safe and effec- firmative showing of effectiveness was tive. not then required to obtain approval. (d) Unless exempted from certifi- Some antibiotic drugs that were not cation, FDA will release without cer- subject to certification, however, were tification an antibiotic drug that was also not subject to the new drug provi- marketed on April 30, 1963, but not sub- sions of the act under informal FDA ject to certification, and not subject to opinions that the drug was ‘‘not a new an approved new drug application on

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that date, unless FDA has made a de- Subpart A—General Provisions termination that the drug has not been shown to be safe or lacks substantial § 431.1 Requests for certification, evidence of effectiveness under the check tests and assays, and working DESI program. FDA is proceeding standards; information and samples under its DESI program to establish required. regulations under section 507 to pro- (a) A request for certification of a vide for certification of those drugs batch (antibiotic Form 7/Form FDA– only if they have been shown to be safe 1677) is to be addressed to the Food and and effective. Drug Administration, Division of Re- search and Testing (HFD–470), 200 C St. [50 FR 7516, Feb. 22, 1985] SW., Washington, DC 20204. (b) [Reserved] PART 431—CERTIFICATION OF (c) A person who requests certifi- ANTIBIOTIC DRUGS cation or check tests and assays of a batch shall submit with his request the Subpart A—General Provisions following information and samples: (1) The batch mark of the drug. Sec. (2) The quantity of each ingredient 431.1 Requests for certification, check tests used in making the batch and a state- and assays, and working standards; infor- mation and samples required. ment that each such ingredient con- 431.5 Samples for sterility testing. forms to the requirements or standards 431.10 Certification. prescribed therefor, if any, by specific 431.11 Conditions on the effectiveness of cer- regulations or official compendium or tificates. otherwise approved by the Commis- 431.12 Certification of antibiotic drugs after sioner. shipment in bulk containers. (3) The size of the batch, including 431.17 Request to provide for certification of the number of containers of each size an antibiotic drug. in the batch. 431.20 Disposition of outdated drugs. (4) The date of the latest assay of the batch. Subpart B—Administrative Procedures (5) The results of the latest tests and 431.50 Forms for certification or exemption assays made by or for him on the batch of antibiotic drugs. as required for the drug by specific reg- 431.51 Suspension of certification service. ulations. 431.52 Hearings. (6) The batch mark(s) of the 431.53 Fees. antibiotic(s) used in making the batch. (7) Unless previously submitted, the Subpart C—Records and Reports results and dates of the latest tests and 431.61 Records of distribution. assays made by or for him on the 431.62 Records retention. antibiotic(s) used in making the batch as required by specific regulations. Subpart D—Confidentiality of Information (8) The number of accurately rep- resentative samples that are required 431.70 Confidentiality of data and informa- for the batch by specific regulations: tion in an investigational new drug no- (i) In the case of drugs such as dry tice for an antibiotic drug. powders, solutions, ointments, and sus- AUTHORITY: Secs. 501, 502, 503, 505, 507, 721 pensions, the sample shall be collected of the Federal Food, Drug, and Cosmetic Act by taking single immediate containers, (21 U.S.C. 351, 352, 353, 355, 357, 376); secs. 215, before or after labeling, at such inter- 301, 351 of the Public Health Service Act (42 vals throughout the entire time of U.S.C. 216, 241, 262); 5 U.S.C. 552. packaging the batch that the quan- SOURCE: 39 FR 18934, May 30, 1974, unless tities packaged during the intervals otherwise noted. are approximately equal. In no case,

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