PART 1300—DEFINITIONS (7) 5- (3b,17b-dihydroxy- androst-5-ene) Sec. (8) 1- ([5a]-androst-1- 1300.01 Definitions relating to controlled en-3,17-dione) substances. (9) 4-androstenedione (androst-4-en- 1300.02 Definitions relating to listed chemi- 3,17-dione) cals. (10) 5-androstenedione (androst-5-en- 1300.03 Definitions relating to electronic or- 3,17-dione) ders for controlled substances and elec- tronic prescriptions for controlled sub- (11) (7a,17a-dimethyl-17b- stances. hydroxyandrost-4-en-3-one) 1300.04 Definitions relating to the dis- (12) (17b-hydroxyandrost-1,4- pensing of controlled substances by diene-3-one) means of the Internet. (13) (androsta-1,4-diene-3,17- 1300.05 Definitions relating to the disposal dione) of controlled substances. (14) (7b,17a-dimethyl-17b- AUTHORITY: 21 U.S.C. 802, 821, 822, 829, hydroxyandrost-4-en-3-one) 871(b), 951, 958(f). (15) (4-chloro-17b- SOURCE: 62 FR 13941, Mar. 24, 1997, unless hydroxyandrost-4-en-3-one) otherwise noted. (16) dehydrochloromethyltestosterone (4-chloro-17b-hydroxy-17a-methyl- § 1300.01 Definitions relating to con- androst-1,4-dien-3-one) trolled substances. (17) (17a- (a) Any term not defined in this part methyl-5a-androst-2-en-17b-ol) shall have the definition set forth in (a.k.a. ‘madol‘) section 102 of the Act (21 U.S.C. 802), (18) D1- (a.k.a.‘1- except that certain terms used in part ‘) (17b-hydroxy-5a- 1316 of this chapter are defined at the androst-1-en-3-one) beginning of each subpart of that part. (19) 4-dihydrotestosterone (17b-hy- (b) As used in parts 1301 through 1308, droxy-androstan-3-one) 1312, and 1317 of this chapter, the fol- (20) (17b-hydroxy-2a- lowing terms shall have the meanings methyl-5a-androstan-3-one) specified: (21) (17a-ethyl-17b- Act means the Controlled Substances hydroxyestr-4-ene) Act, as amended (84 Stat. 1242; 21 U.S.C. (22) (9-fluoro-17a- 801) and/or the Controlled Substances methyl-11b,17b-dihydroxyandrost-4- Import and Export Act, as amended (84 en-3-one) Stat. 1285; 21 U.S.C. 951). (23) (2-formyl-17a-methyl- Administration means the Drug En- 11a,17b-dihydroxyandrost-1,4-dien-3- forcement Administration. one) Administrator means the Adminis- (24) (17a-methyl-17b- trator of the Drug Enforcement Admin- hydroxyandrostano[2,3-c]-furazan) istration. The Administrator has been (25) 13b-ethyl-17b-hydroxygon-4-en-3- delegated authority under the Act by one the Attorney General (28 CFR 0.100). (26) 4-hydroxytestosterone (4,17b- Anabolic means any drug or dihydroxy-androst-4-en-3-one) hormonal substance, chemically and (27) 4-hydroxy-19-nortestosterone pharmacologically related to testos- (4,17b-dihydroxy-estr-4-en-3-one) terone (other than estrogens, (28) (17a-methyl-17b-hy- progestins, corticosteroids, and droxy-5-androstan-3-one) ), and includes: (29) (1a-methyl-17b-hy- (1) 3b,17-dihydroxy-5a- droxy-[5a]-androstan-3-one) (2) 3a,17b-dihydroxy-5a-androstane (30) methandienone (17a-methyl-17b- (3) 5a-androstan-3,17-dione hydroxyandrost-1,4-dien-3-one) (4) 1-androstenediol (3b,17b-dihydroxy- (31) (17a-methyl-3b,17b- 5a-androst-1-ene) dihydroxyandrost-5-ene) (5) 1-androstenediol (3a,17b-dihydroxy- (32) (2a,17a-dimethyl-5a- 5a-androst-1-ene) androstan-17b-ol-3-one) (6) 4-androstenediol (3b,17b-dihydroxy- (33) methenolone (1-methyl-17b-hy- androst-4-ene) droxy-5a-androst-1-en-3-one) 5

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(34) 17a-methyl-3b,17b-dihydroxy-5a-an- (61) (13-hydroxy-3-oxo- drostane 13,17-secoandrosta-1,4-dien-17-oic (35) 17a-methyl-3a,17b-dihydroxy-5a-an- acid lactone) drostane (62) testosterone (17b-hydroxyandrost- (36) 17a-methyl-3b,17b- 4-en-3-one) dihydroxyandrost-4-ene (63) (13b, 17a- (37) 17a-methyl-4-hydroxynandrolone diethyl-17b-hydroxygon-4,9,11-trien- (17a-methyl-4-hydroxy-17b- 3-one) hydroxyestr-4-en-3-one) (64) (17b-hydroxyestr-4,9,11- (38) (17a-methyl-17b- trien-3-one) hydroxyestra-4,9(10)-dien-3-one) (65) Any salt, ester, or ether of a drug (39) methyltrienolone (17a-methyl-17b- or substance described in this para- hydroxyestra-4,9,11-trien-3-one) graph. Except such term does not (40) (17a-methyl- include an that is 17b-hydroxyandrost-4-en-3-one) expressly intended for administra- (41) (7a,17a-dimethyl-17b- tion through implants to cattle or hydroxyestr-4-en-3-one) other nonhuman species and that (42) 17a-methyl-D1-dihydrotestosterone has been approved by the Secretary (17b-hydroxy-17a-methyl-5a- of Health and Human Services for androst-1-en-3-one) (a.k.a. ‘17-a- such administration. If any person methyl-1-testosterone‘) prescribes, dispenses, or distributes (43) (17b-hydroxyestr-4-en-3- such steroid for human use, the one) person shall be considered to have (44) 19-nor-4-androstenediol (3b, 17b- prescribed, dispensed, or distrib- dihydroxyestr-4-ene) uted an anabolic steroid within the (45) 19-nor-4-androstenediol (3a, 17b- meaning of this paragraph. dihydroxyestr-4-ene) Automated dispensing system means a (46) 19-nor-5-androstenediol (3b, 17b- mechanical system that performs oper- dihydroxyestr-5-ene) ations or activities, other than (47) 19-nor-5-androstenediol (3a, 17b- compounding or administration, rel- dihydroxyestr-5-ene) ative to the storage, packaging, count- (48) 19-nor-4,9(10)-androstadienedione ing, labeling, and dispensing of medica- (estra-4,9(10)-diene-3,17-dione) tions, and which collects, controls, and (49) 19-nor-4-androstenedione (estr-4-en- maintains all transaction information. 3,17-dione) Basic class means, as to controlled (50) 19-nor-5-androstenedione (estr-5-en- substances listed in Schedules I and II: 3,17-dione) (1) Each of the opiates, including its (51) norbolethone (13b, 17a-diethyl-17b- isomers, esters, ethers, salts, and salts hydroxygon-4-en-3-one) of isomers, esters, and ethers whenever (52) (4-chloro-17b- the existence of such isomers, esters, hydroxyestr-4-en-3-one) ethers, and salts is possible within the (53) (17a-ethyl-17b- specific chemical designation, listed in hydroxyestr-4-en-3-one) § 1308.11(b) of this chapter; (54) normethandrolone (17a-methyl-17b- (2) Each of the opium derivatives, in- hydroxyestr-4-en-3-one) cluding its salts, isomers, and salts of (55) (17a-methyl-17b-hy- isomers whenever the existence of such droxy-2-oxa-[5a]-androstan-3-one) salts, isomers, and salts of isomers is (56) (17a-methyl-4,17b- possible within the specific chemical dihydroxyandrost-4-en-3-one) designation, listed in § 1308.11(c) of this (57) (17a-methyl-2- chapter; hydroxymethylene-17b-hydroxy- (3) Each of the hallucinogenic sub- [5a]-androstan-3-one) stances, including its salts, isomers, (58) (17b-hydroxy-5a- and salts of isomers whenever the ex- androstano[3,2-c]pyrazole) istence of such salts, isomers, and salts (59) (17a-methyl-17b-hy- of isomers is possible within the spe- droxy-[5a]-androst-2-eno[3,2-c]-pyr- cific chemical designation, listed in azole) § 1308.11(d) of this chapter; (60) (17b-hydroxy-2-methyl- (4) Each of the following substances, [5a]-androst-1-en-3-one) whether produced directly or indirectly 6

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by extraction from substances of vege- fill pharmacy have a contractual rela- table origin, or independently by tionship providing for such activities means of chemical synthesis, or by a or share a common owner. combination of extraction and chem- Collection means to receive a con- ical synthesis: trolled substance for the purpose of de- (i) Opium, including raw opium, struction from an ultimate user, a per- opium extracts, opium fluid extracts, son lawfully entitled to dispose of an powdered opium, granulated opium, de- ultimate user decedent’s property, or a odorized opium and tincture of opium; long-term care facility on behalf of an (ii) Apomorphine; ultimate user who resides or has re- (iii) Codeine; sided at that facility. The term col- (iv) Etorphine hydrochloride; lector means a registered manufacturer, (v) Ethylmorphine; distributor, reverse distributor, nar- (vi) Hydrocodone; cotic treatment program, hospital/clin- (vii) Hydromorphone; ic with an on-site pharmacy, or retail (viii) Metopon; pharmacy that is authorized under this (ix) Morphine; chapter to so receive a controlled sub- (x) Oxycodone; stance for the purpose of destruction. (xi) Oxymorphone; Commercial container means any bot- (xii) Thebaine; tle, jar, tube, ampule, or other recep- (xiii) Mixed alkaloids of opium listed tacle in which a substance is held for in § 1308.12(b)(2) of this chapter; distribution or dispensing to an ulti- (xiv) Cocaine; and mate user, and in addition, any box or (xv) Ecgonine; package in which the receptacle is held (5) Each of the opiates, including its for distribution or dispensing to an ul- isomers, esters, ethers, salts, and salts timate user. The term commercial con- of isomers, esters, and ethers whenever tainer does not include any package the existence of such isomers, esters, liner, package insert or other material ethers, and salts is possible within the kept with or within a commercial con- specific chemical designation, listed in tainer, nor any carton, crate, drum, or § 1308.12(c) of this chapter; and other package in which commercial (6) Methamphetamine, its salts, iso- mers, and salts of its isomers; containers are stored or are used for (7) Amphetamine, its salts, optical shipment of controlled substances. isomers, and salts of its optical iso- Competent national authority, for pur- mers; poses of importation and exportation of (8) Phenmetrazine and its salts; controlled substances and listed chemi- (9) Methylphenidate; cals, means an entity lawfully entitled (10) Each of the substances having a to authorize the import and export of depressant effect on the central nerv- controlled substances, and to regulate ous system, including its salts, iso- or enforce national controls over listed mers, and salts of isomers whenever chemicals, and included as such in the the existence of such salts, isomers, directory of ‘‘Competent National Au- and salts of isomers is possible within thorities Under the International Drug the specific chemical designation, list- Control Treaties’’ published by the ed in § 1308.12(e) of this chapter. United Nations Office on Drugs and Central fill pharmacy means a phar- Crime. For purposes of exports of nar- macy which is permitted by the state cotic drugs, the term also includes in which it is located to prepare con- freely associated states authorized to trolled substances orders for dispensing receive such exports pursuant to 48 pursuant to a valid prescription trans- U.S.C. 1972. mitted to it by a registered retail phar- Compounder means any person engag- macy and to return the labeled and ing in maintenance or detoxification filled prescriptions to the retail phar- treatment who also mixes, prepares, macy for delivery to the ultimate user. packages or changes the dosage form of Such central fill pharmacy shall be a narcotic drug listed in Schedules II, deemed ‘‘authorized’’ to fill prescrip- III, IV or V for use in maintenance or tions on behalf of a retail pharmacy detoxification treatment by another only if the retail pharmacy and central narcotic treatment program.

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Controlled substance has the meaning contents include controlled substances) given in section 802(6) of Title 21, are, in the course of delivery to, or re- United States Code (U.S.C.). turn from, customers, transferred in Customs officer means either an Offi- less than 24 hours. A distributing reg- cer of the Customs as defined in 19 istrant who operates a freight for- U.S.C. 1401(i) (that is, of the U.S. Cus- warding facility may use the facility to toms and Border Protection), or any transfer controlled substances from individual duly authorized to accept any location the distributing reg- entries of merchandise, to collect du- istrant operates that is registered with ties, and to enforce the customs laws of the Administration to manufacture, any commonwealth, territory, or pos- distribute, or import controlled sub- session of the United States. stances, or, with respect to returns, Customs territory of the United States registered to dispense controlled sub- means the several States, the District stances, provided that the notice re- of Columbia, and Puerto Rico. quired by § 1301.12(b)(4) of Part 1301 of Detoxification treatment means the this chapter has been submitted and dispensing, for a period of time as spec- approved. For purposes of this defini- ified below, of a narcotic drug or nar- tion, a distributing registrant is a per- cotic drugs in decreasing doses to an son who is registered with the Admin- individual to alleviate adverse physio- istration as a manufacturer, dis- logical or psychological effects inci- tributor (excluding reverse dis- dent to withdrawal from the contin- tributor), and/or importer. uous or sustained use of a narcotic Hearing means: drug and as a method of bringing the (1) In part 1301 of this chapter, any individual to a narcotic drug-free state hearing held for the granting, denial, within such period of time. There are revocation, or suspension of a registra- two types of detoxification treatment: tion pursuant to sections 303, 304, and Short-term detoxification treatment 1008 of the Act (21 U.S.C. 823, 824 and and long-term detoxification treat- 958). ment. (2) In part 1303 of this chapter, any (1) Short-term detoxification treat- hearing held regarding the determina- ment is for a period not in excess of 30 tion of aggregate production quota or days. the issuance, adjustment, suspension, (2) Long-term detoxification treat- or denial of a procurement quota or an ment is for a period more than 30 days individual manufacturing quota. but not in excess of 180 days. (3) In part 1308 of this chapter, any Dispenser means an individual practi- hearing held for the issuance, amend- tioner, institutional practitioner, phar- ment, or repeal of any rule issuable macy or pharmacist who dispenses a pursuant to section 201 of the Act (21 controlled substance. U.S.C. 811). Export means, with respect to any ar- Import means, with respect to any ar- ticle, any taking out or removal of ticle, any bringing in or introduction such article from the United States of such article into the customs terri- (whether or not such taking out or re- tory of the United States from any moval constitutes an exportation with- place outside thereof (but within the in the meaning of the customs laws, ex- United States), or into the United port control laws enforced by other States from any place outside thereof agencies, or related laws of the United (whether or not such bringing in or in- States). troduction constitutes an importation Exporter includes every person who within the meaning of the tariff laws of exports, or who acts as an export the United States). broker for exportation of, controlled Importer includes every person who substances listed in any schedule. imports, or who acts as an import Freight forwarding facility means a broker for importation of, controlled separate facility operated by a distrib- substances listed in any schedule. uting registrant through which sealed, Individual practitioner means a physi- packaged controlled substances in un- cian, dentist, veterinarian, or other in- marked shipping containers (i.e., the dividual licensed, registered, or other- containers do not indicate that the wise permitted, by the United States or

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the jurisdiction in which he/she prac- are positional isomers. For purposes of tices, to dispense a controlled sub- this definition, the ‘‘core structure’’ is stance in the course of professional the parent molecule that is the com- practice, but does not include a phar- mon basis for the class; for example, macist, a pharmacy, or an institutional tryptamine, phenethylamine, or practitioner. ergoline. Examples of rearrangements Institutional practitioner means a hos- resulting in creation and/or destruction pital or other person (other than an in- of chemical functionalities (and there- dividual) licensed, registered, or other- fore resulting in compounds which are wise permitted, by the United States or not positional isomers) include, but are the jurisdiction in which it practices, not limited to: Ethoxy to alpha-hy- to dispense a controlled substance in droxyethyl, hydroxy and methyl to the course of professional practice, but methoxy, or the repositioning of a phe- does not include a pharmacy. nolic or alcoholic hydroxy group to Interested person means any person create a hydroxyamine. Examples of adversely affected or aggrieved by any rearrangements resulting in com- rule or proposed rule issuable pursuant pounds which would be positional iso- to section 201 of the Act (21 U.S.C. 811). mers include: Tert-butyl to sec-butyl, Inventory means all factory and methoxy and ethyl to isopropoxy, N,N- branch stocks in finished form of a diethyl to N-methyl-N-propyl, or alpha- basic class of controlled substance methylamino to N-methylamino. manufactured or otherwise acquired by Label means any display of written, a registrant, whether in bulk, commer- printed, or graphic matter placed upon cial containers, or contained in phar- the commercial container of any con- maceutical preparations in the posses- trolled substance by any manufacturer sion of the registrant (including stocks of such substance. held by the registrant under separate Labeling means all labels and other registration as a manufacturer, im- written, printed, or graphic matter: porter, exporter, or distributor). (1) Upon any controlled substance or Isomer means: (1) The optical isomer, except as used any of its commercial containers or in § 1308.11(d) and § 1308.12(b)(4) of this wrappers, or chapter. As used in § 1308.11(d) of this (2) Accompanying such controlled chapter, the term ‘‘isomer’’ means any substance. optical, positional, or geometric iso- Long Term Care Facility (LTCF) means mer. As used in § 1308.12(b)(4) of this a nursing home, retirement care, men- chapter, the term ‘‘isomer’’ means any tal care or other facility or institution optical or geometric isomer; which provides extended health care to (2) As used in § 1308.11(d) of this chap- resident patients. ter, the term ‘‘positional isomer’’ Maintenance treatment means the dis- means any substance possessing the pensing for a period in excess of twen- same molecular formula and core ty-one days, of a narcotic drug or nar- structure and having the same func- cotic drugs in the treatment of an indi- tional group(s) and/or substituent(s) as vidual for dependence upon heroin or those found in the respective Schedule other morphine-like drug. I , attached at any posi- Manufacture means the producing, tion(s) on the core structure, but in preparation, propagation, such manner that no new chemical compounding, or processing of a drug functionalities are created and no ex- or other substance or the packaging or isting chemical functionalities are de- repackaging of such substance, or the stroyed relative to the respective labeling or relabeling of the commer- Schedule I hallucinogen. Rearrange- cial container of such substance, but ments of alkyl moieties within or be- does not include the activities of a tween functional group(s) or substit- practitioner who, as an incident to his/ uent(s), or divisions or combinations of her administration or dispensing such alkyl moieties, that do not create new substance in the course of his/her pro- chemical functionalities or destroy ex- fessional practice, prepares, com- isting chemical functionalities, are al- pounds, packages or labels such sub- lowed i.e., result in compounds which stance.

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Manufacturer means a person who Narcotic treatment program means a manufactures a drug or other sub- program engaged in maintenance and/ stance, whether under a registration as or detoxification treatment with nar- a manufacturer or under authority of cotic drugs. registration as a researcher or chem- Net disposal means, for a stated pe- ical analyst. riod, the quantity of a basic class of Mid-level practitioner means an indi- controlled substance distributed by the vidual practitioner, other than a physi- registrant to another person, plus the cian, dentist, veterinarian, or podia- quantity of that basic class used by the trist, who is licensed, registered, or registrant in the production of (or con- otherwise permitted by the United verted by the registrant into) another States or the jurisdiction in which he/ basic class of controlled substance or a she practices, to dispense a controlled noncontrolled substance, plus the substance in the course of professional quantity of that basic class otherwise practice. Examples of mid-level practi- disposed of by the registrant, less the tioners include, but are not limited to, quantity of that basic class returned to health care providers such as nurse the registrant by any purchaser, and practitioners, nurse midwives, nurse less the quantity of that basic class anesthetists, clinical nurse specialists distributed by the registrant to an- and physician assistants who are au- other registered manufacturer of that thorized to dispense controlled sub- basic class for purposes other than use stances by the State in which they in the production of, or conversion practice. into, another basic class of controlled Name means the official name, com- substance or a noncontrolled substance mon or usual name, chemical name, or or in the manufacture of dosage forms brand name of a substance. of that basic class. Narcotic drug means any of the fol- Person includes any individual, cor- lowing whether produced directly or in- poration, government or governmental directly by extraction from substances subdivision or agency, business trust, of vegetable origin or independently by partnership, association, or other legal means of chemical synthesis or by a entity. combination of extraction and chem- Pharmacist means any pharmacist li- ical synthesis: censed by a State to dispense con- (1) Opium, opiates, derivatives of trolled substances, and shall include opium and opiates, including their iso- any other person (e.g., pharmacist in- mers, esters, ethers, salts, and salts of tern) authorized by a State to dispense isomers, esters, and ethers whenever controlled substances under the super- the existence of such isomers, esters, vision of a pharmacist licensed by such ethers and salts is possible within the State. specific chemical designation. Such Port of entry means, unless distin- term does not include the isoquinoline guished as being a foreign port of alkaloids of opium. entry, any place at which a customs of- (2) Poppy straw and concentrate of ficer is duly authorized to accept en- poppy straw. tries of merchandise, to collect duties, (3) Coca leaves, except coca leaves and to enforce the various provisions of and extracts of coca leaves from which the customs laws of the United States cocaine, ecgonine and derivatives of ec- (whether or not such place is a port of gonine or their salts have been re- entry as defined in title 19 of the moved. United States Code or its associated (4) Cocaine, its salts, optical and geo- implementing regulations). Examples metric isomers, and salts of isomers. of ports of entry include, but are not (5) Ecgonine, its derivatives, their limited to, places designated as ports salts, isomers and salts of isomers. of entry or customs stations in title 19 (6) Any compound, mixture, or prepa- of the Code of Federal Regulations or by ration which contains any quantity of the governing customs authority of any of the substances referred to in that area. When shipments are trans- paragraphs (1) through (5) of this defi- ported under U.S. Customs and Border nition. Protection’s immediate transportation

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procedures, the port of entry shall be Registrant means any person who is the port of final destination. registered pursuant to either section Port of export means, unless distin- 303 or section 1008 of the Act (21 U.S.C. guished as being a foreign port of ex- 823 or 958). port, any place under the control of a Return information means supple- customs officer where goods are loaded mental information required to be re- on an aircraft, vessel or other convey- ported to the Administration following ance for export outside of the United an import or export transaction con- States. For goods loaded aboard an air- taining the particulars of the trans- craft or vessel in the United States, action and any other information as that stops at several ports before de- the Administration may specify. parting the United States, the port of Reverse distribute means to acquire export is the first port where the goods controlled substances from another were actually loaded. For goods off- registrant or law enforcement for the loaded from the original conveyance to purpose of: another conveyance (even if the air- (1) Return to the registered manufac- craft or vessel belongs to the same car- turer or another registrant authorized rier) at any port subsequent to the port by the manufacturer to accept returns where the first on-loading occurred in on the manufacturer’s behalf; or the United States, the port where the (2) Destruction. goods were loaded onto the last con- Reverse distributor is a person reg- veyance before departing the United istered with the Administration as a States is the port of export. reverse distributor. Prescription means an order for medi- Supplier means any registered person cation which is dispensed to or for an entitled to fill order forms pursuant to ultimate user but does not include an § 1305.06 of this chapter. order for which is dispensed United States, when used in a geo- for immediate administration to the graphic sense, means all places and ultimate user (e.g., an order to dis- waters, continental or insular, subject pense a drug to a bed patient for imme- to the jurisdiction of the United diate administration in a hospital is States, which, in addition to the cus- not a prescription). toms territory of the United States, in- Proceeding means all actions taken clude but are not limited to the U.S. for the issuance, amendment, or repeal Virgin Islands, Guam, American of any rule issued pursuant to section Samoa, and the Northern Mariana Is- 201 of the Act (21 U.S.C. 811), com- lands. mencing with the publication by the Administrator of the proposed rule, [62 FR 13941, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 68 FR 37409, June 24, amended rule, or repeal in the FEDERAL 2003; 68 FR 41228, July 11, 2003; 70 FR 25465, REGISTER. May 13, 2005; 70 FR 74656, Dec. 16, 2005; 71 FR Purchaser means any registered per- 60427, Oct. 13, 2006; 72 FR 67852, Dec. 3, 2007; son entitled to obtain and execute 74 FR 63609, Dec. 4, 2009; 77 FR 4230, Jan. 27, order forms pursuant to §§ 1305.04 and 2012; 77 FR 44461, July 30, 2012; 79 FR 53559, 1305.06. Sept. 9, 2014; 81 FR 97018, Dec. 30, 2016] Readily retrievable means that certain records are kept by automatic data § 1300.02 Definitions relating to listed processing systems or other electronic chemicals. or mechanized recordkeeping systems (a) Any term not defined in this part in such a manner that they can be sep- shall have the definition set forth in arated out from all other records in a section 102 of the Act (21 U.S.C. 802), reasonable time and/or records are kept except that certain terms used in part on which certain items are asterisked, 1316 of this chapter are defined at the redlined, or in some other manner vis- beginning of each subpart of that part. ually identifiable apart from other (b) As used in parts 1309, 1310, and items appearing on the records. 1313 of this chapter, the following Register and registration refer only to terms shall have the meaning specified: registration required and permitted by Act means the Controlled Substances sections 303 or 1007 of the Act (21 U.S.C. Act, as amended (84 Stat. 1242; 21 U.S.C. 823 or 957). 801) and/or the Controlled Substances

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Import and Export Act, as amended (84 Combination ephedrine product means Stat. 1285; 21 U.S.C. 951). a drug product containing ephedrine or Administration means the Drug En- its salts, optical isomers, or salts of op- forcement Administration. tical isomers, and therapeutically sig- Administrator means the Adminis- nificant quantities of another active trator of the Drug Enforcement Admin- medicinal ingredient. istration. The Administrator has been Competent national authority, for pur- delegated authority under the Act by poses of importation and exportation of the Attorney General (28 CFR 0.100). controlled substances and listed chemi- At retail, with respect to the sale or cals, means an entity lawfully entitled purchase of a scheduled listed chemical to authorize the import and export of product, means a sale or purchase for controlled substances, and to regulate personal use, respectively. or enforce national controls over listed Broker and trader mean any indi- chemicals, and included as such in the vidual, corporation, corporate division, directory of ‘‘Competent National Au- partnership, association, or other legal thorities Under the International Drug entity which assists in arranging an Control Treaties’’ published by the international transaction in a listed United Nations Office on Drugs and chemical by— Crime. (1) Negotiating contracts; Customs officer means either an Offi- (2) Serving as an agent or inter- cer of the Customs as defined in 19 mediary; or U.S.C. 1401(i) (that is, of the U.S. Cus- (3) Fulfilling a formal obligation to toms and Border Protection), or any complete the transaction by bringing individual duly authorized to accept together a buyer and seller, a buyer entries of merchandise, to collect du- and transporter, or a seller and trans- ties, and to enforce the customs laws of porter, or by receiving any form of any commonwealth, territory, or pos- compensation for so doing. session of the United States. Chemical export means transferring Customs territory of the United States ownership or control, or the sending or means the several States, the District taking of threshold quantities of listed of Columbia, and Puerto Rico. chemicals out of the United States Drug product means an active ingre- (whether or not such sending or taking dient in dosage form that has been ap- out constitutes an exportation within proved or otherwise may be lawfully the meaning of the customs and related marketed under the Federal Food, laws of the United States). Drug, and Cosmetic Act for distribu- Chemical exporter is a regulated per- tion in the United States. son who, as the principal party in in- Encapsulating machine means any terest in the export transaction, has manual, semi-automatic, or fully auto- the power and responsibility for deter- matic equipment which may be used to mining and controlling the sending of fill shells or capsules with any pow- the listed chemical out of the United dered, granular, semi-solid, or liquid States. material. Chemical importer is a regulated per- Established business relationship means son who, as the principal party in in- the regulated person has imported or terest in the import transaction, has exported a listed chemical at least the power and responsibility for deter- once within the past six months, or mining and controlling the bringing in twice within the past twelve months or introduction of the listed chemical from or to a foreign manufacturer, dis- into the United States. tributor, or end user of the chemical Chemical mixture means a combina- that has an established business with a tion of two or more chemical sub- fixed street address. A person or busi- stances, at least one of which is not a ness that functions as a broker or listed chemical, except that such term intermediary is not a customer for pur- does not include any combination of a poses of this definition. listed chemical with another chemical Established record as an importer that is present solely as an impurity or means that the regulated person has which has been created to evade the re- imported a listed chemical at least quirements of the Act. once within the past six months, or

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twice within the past twelve months port) or whether the stand is located from a foreign supplier. on unimproved real estate (such as a Export means, with respect to any ar- lot or field leased for retail purposes). ticle, any taking out or removal of Name means the official name, com- such article from the United States mon or usual name, chemical name, or (whether or not such taking out or re- brand name of a substance. moval constitutes an exportation with- Person includes any individual, cor- in the meaning of the customs laws, ex- poration, government or governmental port control laws enforced by other subdivision or agency, business trust, agencies, or related laws of the United partnership, association, or other legal States). entity. Hearing means any hearing held for Port of entry, unless distinguished as the granting, denial, revocation, or being a foreign port of entry, means suspension of a registration pursuant any place at which a customs officer is to sections 303, 304, and 1008 of the Act duly authorized to accept entries of (21 U.S.C. 823, 824 and 958). merchandise, to collect duties, and to Import means, with respect to any ar- enforce the various provisions of the ticle, any bringing in or introduction customs laws of the United States of such article into the customs terri- (whether or not such place is a port of tory of the United States from any entry as defined in title 19 of the place outside thereof (but within the United States Code or its associated United States), or into the United implementing regulations). Examples States from any place outside thereof of ports of entry include, but are not (whether or not such bringing in or in- limited to, places designated as ports troduction constitutes an importation of entry or customs stations in title 19 within the meaning of the tariff laws of of the Code of Federal Regulations or by the United States). the governing customs authority of International transaction means a that area. When shipments are trans- transaction involving the shipment of ported under U.S. Customs and Border a listed chemical across an inter- Protection immediate transportation national border (other than a United procedures, the port of entry shall be States border) in which a broker or the port of final destination. trader located in the United States Port of export means, unless distin- participates. guished as being a foreign port of ex- Listed chemical means any List I port, any place under the control of a chemical or List II chemical. customs officer where goods are loaded List I chemical means a chemical spe- on an aircraft, vessel or other convey- cifically designated by the Adminis- ance for export outside of the United trator in § 1310.02(a) of this chapter States. For goods loaded aboard an air- that, in addition to legitimate uses, is craft or vessel in the United States used in manufacturing a controlled that stops at several ports before de- substance in violation of the Act and is parting the United States, the port of important to the manufacture of a con- export is the first port where the goods trolled substance. were loaded. For goods off-loaded from List II chemical means a chemical, the original conveyance to another other than a List I chemical, specifi- conveyance (even if the aircraft or ves- cally designated by the Administrator sel belongs to the same carrier) at any in § 1310.02(b) of this chapter that, in port subsequent to the port where the addition to legitimate uses, is used in first on-loading occurred in the United manufacturing a controlled substance States, the port where the goods were in violation of the Act. loaded onto the last conveyance before Mobile retail vendor means a person or departing the United States is the port entity that makes sales at retail from of export. For reporting purposes, in a stand that is intended to be tem- the case of an otherwise lawful export porary or is capable of being moved occurring by mail, the port of export is from one location to another, whether the place of mailing. the stand is located within or on the Readily retrievable means that certain premises of a fixed facility (such as a records are kept by automatic data kiosk at a shopping center or an air- processing systems or other electronic

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or mechanized recordkeeping systems lated person; in this context, agents or in such a manner that they can be sep- employees means individuals under the arated out from all other records in a direct management and control of the reasonable time and/or records are kept regulated person; on which certain items are asterisked, (ii) A delivery of a listed chemical to redlined, or in some other manner vis- or by a common or contract carrier for ually identifiable apart from other carriage in the lawful and usual course items appearing on the records. of the business of the common or con- Register and registration refer only to tract carrier, or to or by a warehouse- registration required and permitted by man for storage in the lawful and usual sections 303 or 1007 of the Act (21 U.S.C. course of the business of the ware- 823 or 957). houseman, except that if the carriage Registrant means any person who is or storage is in connection with the registered pursuant to either section distribution, importation, or expor- 303 or section 1008 of the Act (21 U.S.C. tation of a listed chemical to a third 823 or 958). person, this paragraph does not relieve Regular customer means a person with a distributor, importer, or exporter whom the regulated person has an es- from compliance with parts 1309, 1310, tablished business relationship for a 1313, and 1315 of this chapter; specified listed chemical or chemicals (iii) Any category of transaction or that has been reported to the Adminis- any category of transaction for a spe- tration subject to the criteria estab- cific listed chemical or chemicals spec- lished in part 1313 of this chapter. ified by regulation of the Adminis- Regular importer means, with respect trator as excluded from this definition to a listed chemical, a person that has as unnecessary for enforcement of the an established record as an importer of Act; that listed chemical that is reported to (iv) Any transaction in a listed chem- the Administrator. ical that is contained in a drug other Regulated person means any indi- than a scheduled listed chemical prod- vidual, corporation, partnership, asso- ciation, or other legal entity who man- uct that may be marketed or distrib- ufactures, distributes, imports, or ex- uted lawfully in the United States ports a listed chemical, a tableting ma- under the Federal Food, Drug, and Cos- chine, or an encapsulating machine, or metic Act, subject to paragraph (1)(v) who acts as a broker or trader for an of this definition, unless— international transaction involving a (A) The Administrator has deter- listed chemical, tableting machine, or mined pursuant to the criteria in encapsulating machine. § 1310.10 of this chapter that the drug or Regulated seller means a retail dis- group of drugs is being diverted to ob- tributor (including a pharmacy or a tain the listed chemical for use in the mobile retail vendor), except that the illicit production of a controlled sub- term does not include an employee or stance; and agent of the distributor. (B) The quantity of the listed chem- Regulated transaction means: ical contained in the drug included in (1) A distribution, receipt, sale, im- the transaction or multiple trans- portation, or exportation of a listed actions equals or exceeds the threshold chemical, or an international trans- established for that chemical; action involving shipment of a listed (v) Any transaction in a scheduled chemical, or if the Administrator es- listed chemical product that is a sale tablishes a threshold amount for a spe- at retail by a regulated seller or a dis- cific listed chemical, a threshold tributor required to submit reports amount as determined by the Adminis- under § 1310.03(c) of this chapter; or trator, which includes a cumulative (vi) Any transaction in a chemical threshold amount for multiple trans- mixture designated in §§ 1310.12 and actions, of a listed chemical, except 1310.13 of this chapter that the Admin- that such term does not include: istrator has exempted from regulation. (i) A domestic lawful distribution in (2) A distribution, importation, or ex- the usual course of business between portation of a tableting machine or en- agents or employees of a single regu- capsulating machine except that such

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term does not include a domestic law- United States, when used in a geo- ful distribution in the usual course of graphic sense, means all places and business between agents and employees waters, continental or insular, subject of a single regulated person; in this to the jurisdiction of the United context, agents or employees means in- States, which, in addition to the cus- dividuals under the direct management toms territory of the United States, in- and control of the regulated person. clude but are not limited to the U.S. Retail distributor means a grocery Virgin Islands, Guam, American store, general merchandise store, drug Samoa, and the Northern Mariana Is- store, or other entity or person whose lands. activities as a distributor relating to Valid prescription means a prescrip- drug products containing tion that is issued for a legitimate pseudoephedrine or phenylpropanola- medical purpose by an individual prac- mine are limited almost exclusively to titioner licensed by law to administer sales for personal use, both in number and prescribe the drugs concerned and of sales and volume of sales, either di- acting in the usual course of the prac- rectly to walk-in customers or in face- titioner’s professional practice. to-face transactions by direct sales. [75 FR 16304, Mar. 31, 2010, as amended at 77 Also for the purposes of this paragraph, FR 4233, Jan. 27, 2012; 81 FR 97019, Dec. 30, a ‘‘grocery store’’ is an entity within 2016] Standard Industrial Classification (SIC) code 5411, a ‘‘general merchandise § 1300.03 Definitions relating to elec- store’’ is an entity within SIC codes tronic orders for controlled sub- 5300 through 5399 and 5499, and a ‘‘drug stances and electronic prescriptions store’’ is an entity within SIC code for controlled substances. 5912. For the purposes of this chapter, the Return information means supple- following terms shall have the mean- mental information required to be re- ings specified: ported to the Administration following Application service provider means an an import or export transaction con- entity that sells electronic prescrip- taining the particulars of the trans- tion or pharmacy applications as a action and any other information as hosted service, where the entity con- the Administration may specify. trols access to the application and Scheduled listed chemical product maintains the software and records on means: its servers. (1) A product that contains ephed- Audit trail means a record showing rine, pseudoephedrine, or phenyl- who has accessed an information tech- propanolamine and may be marketed nology application and what operations or distributed lawfully in the United the user performed during a given pe- States under the Federal Food, Drug, riod. and Cosmetic Act as a nonprescription Authentication means verifying the drug. Ephedrine, pseudoephedrine, and identity of the user as a prerequisite to phenylpropanolamine include their allowing access to the information ap- salts, optical isomers, and salts of opti- plication. cal isomers. Authentication protocol means a well (2) Scheduled listed chemical product specified message exchange process does not include any product that is a that verifies possession of a token to controlled substance under part 1308 of remotely authenticate a person to an this chapter. In the absence of such application. scheduling by the Attorney General, a Biometric authentication means au- chemical specified in paragraph (1) of thentication based on measurement of this definition may not be considered the individual’s physical features or re- to be a controlled substance. peatable actions where those features Tableting machine means any manual, or actions are both distinctive to the semi-automatic, or fully automatic individual and measurable. equipment which may be used for the Biometric subsystem means the hard- compaction or molding of powdered or ware and software used to capture, granular solids, or semi-solid material, store, and compare biometric data. The to produce coherent solid tablets. biometric subsystem may be part of a

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larger application. The biometric sub- (1) Identifies the certification au- system is an automated system capable thority issuing it; of: (2) Names or otherwise identifies the (1) Capturing a biometric sample certificate holder; from an end user. (3) Contains a public key that cor- (2) Extracting and processing the bio- responds to a private key under the metric data from that sample. sole control of the certificate holder; (3) Storing the extracted information (4) Identifies the operational period; in a database. and (4) Comparing the biometric data (5) Contains a serial number and is with data contained in one or more ref- digitally signed by the certification au- erence databases. thority issuing it. (5) Determining how well the stored Digital signature means a record cre- data matches the newly captured data ated when a file is algorithmically and indicating whether an identifica- transformed into a fixed length digest tion or verification of identity has been that is then encrypted using an asym- achieved. metric cryptographic private key asso- Cache means to download and store ciated with a digital certificate. The information on a local server or hard combination of the encryption and al- drive. gorithm transformation ensure that Certificate policy means a named set the signer’s identity and the integrity of rules that sets forth the applica- of the file can be confirmed. bility of the specific digital certificate Digitally sign means to affix a digital to a particular community or class of signature to a data file. application with common security re- Electronic prescription means a pre- quirements. scription that is generated on an elec- Certificate revocation list (CRL) means tronic application and transmitted as a list of revoked, but unexpired certifi- an electronic data file. cates issued by a certification author- Electronic prescription application pro- ity. vider means an entity that develops or Certification authority (CA) means an markets electronic prescription soft- organization that is responsible for ware either as a stand-alone applica- verifying the identity of applicants, au- tion or as a module in an electronic thorizing and issuing a digital certifi- health record application. cate, maintaining a directory of public Electronic signature means a method keys, and maintaining a Certificate of signing an electronic message that Revocation List. identifies a particular person as the Certified information systems auditor source of the message and indicates the (CISA) means an individual who has person’s approval of the information been certified by the Information Sys- contained in the message. tems Audit and Control Association as False match rate means the rate at qualified to audit information systems which an impostor’s biometric is false- and who performs compliance audits as ly accepted as being that of an author- a regular ongoing business activity. ized user. It is one of the statistics Credential means an object or data used to measure biometric performance structure that authoritatively binds an when operating in the verification or identity (and optionally, additional at- authentication task. The false match tributes) to a token possessed and con- rate is similar to the false accept (or trolled by a person. acceptance) rate. Credential service provider (CSP) False non-match rate means the rate means a trusted entity that issues or at which a genuine user’s biometric is registers tokens and issues electronic falsely rejected when the user’s bio- credentials to individuals. The CSP metric data fail to match the enrolled may be an independent third party or data for the user. It is one of the statis- may issue credentials for its own use. tics used to measure biometric per- CSOS means controlled substance or- formance when operating in the dering system. verification or authentication task. Digital certificate means a data record The false match rate is similar to the that, at a minimum— false reject (or rejection) rate, except

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that it does not include the rate at Installed electronic prescription applica- which a biometric system fails to ac- tion means software that is used to cre- quire a biometric sample from a gen- ate electronic prescriptions and that is uine user. installed on a practitioner’s computers FIPS means Federal Information and servers, where access and records Processing Standards. These Federal are controlled by the practitioner. standards, as incorporated by reference Installed pharmacy application means in § 1311.08 of this chapter, prescribe software that is used to process pre- specific performance requirements, scription information and that is in- practices, formats, communications stalled on a pharmacy’s computers or protocols, etc., for hardware, software, servers and is controlled by the phar- data, etc. macy. FIPS 140–2, as incorporated by ref- Intermediary means any technology erence in § 1311.08 of this chapter, system that receives and transmits an means the National Institute of Stand- electronic prescription between the ards and Technology publication enti- practitioner and pharmacy. tled ‘‘Security Requirements for Cryp- Key pair means two mathematically tographic Modules,’’ a Federal stand- related keys having the properties ard for security requirements for cryp- that: tographic modules. (1) One key can be used to encrypt a FIPS 180–2, as incorporated by ref- message that can only be decrypted erence in § 1311.08 of this chapter, using the other key; and means the National Institute of Stand- (2) Even knowing one key, it is ards and Technology publication enti- computationally infeasible to discover tled ‘‘Secure Hash Standard,’’ a Fed- the other key. eral secure hash standard. NIST means the National Institute of FIPS 180–3, as incorporated by ref- Standards and Technology. erence in § 1311.08 of this chapter, NIST SP 800–63–1, as incorporated by means the National Institute of Stand- reference in § 1311.08 of this chapter, ards and Technology publication enti- means the National Institute of Stand- tled ‘‘Secure Hash Standard (SHS),’’ a ards and Technology publication enti- Federal secure hash standard. tled ‘‘Electronic Authentication Guide- FIPS 186–2, as incorporated by ref- line,’’ a Federal standard for electronic erence in § 1311.08 of this chapter, authentication. means the National Institute of Stand- NIST SP 800–76–1, as incorporated by ards and Technology publication enti- reference in § 1311.08 of this chapter, tled ‘‘Digital Signature Standard,’’ a means the National Institute of Stand- Federal standard for applications used ards and Technology publication enti- to generate and rely upon digital signa- tled ‘‘Biometric Data Specification for tures. Personal Identity Verification,’’ a Fed- FIPS 186–3, as incorporated by ref- eral standard for biometric data speci- erence in § 1311.08 of this chapter, fications for personal identity means the National Institute of Stand- verification. ards and Technology publication enti- Operating point means a point chosen tled ‘‘Digital Signature Standard on a receiver operating characteristic (DSS),’’ a Federal standard for applica- (ROC) curve for a specific algorithm at tions used to generate and rely upon which the biometric system is set to digital signatures. function. It is defined by its cor- Hard token means a cryptographic responding coordinates—a false match key stored on a special hardware device rate and a false non-match rate. An (e.g., a PDA, cell phone, smart card, ROC curve shows graphically the trade- USB drive, one-time password device) off between the principal two types of rather than on a general purpose com- errors (false match rate and false non- puter. match rate) of a biometric system by Identity proofing means the process by plotting the performance of a specific which a credential service provider or algorithm on a specific set of data. certification authority validates suffi- Paper prescription means a prescrip- cient information to uniquely identify tion created on paper or computer gen- a person. erated to be printed or transmitted via

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facsimile that meets the requirements tion may have different names (e.g., of part 1306 of this chapter including a approve, sign, transmit), but it serves manual signature. as the practitioner’s final authoriza- Password means a secret, typically a tion that he intends to issue the pre- character string (letters, numbers, and scription for a legitimate medical rea- other symbols), that a person memo- son in the normal course of his profes- rizes and uses to authenticate his iden- sional practice. tity. SysTrust means a professional service PDA means a Personal Digital Assist- performed by a qualified certified pub- ant, a handheld computer used to man- lic accountant to evaluate one or more age contacts, appointments, and tasks. aspects of electronic systems. Pharmacy application provider means Third-party audit means an inde- an entity that develops or markets pendent review and examination of software that manages the receipt and records and activities to assess the ade- processing of electronic prescriptions. quacy of system controls, to ensure Private key means the key of a key compliance with established policies pair that is used to create a digital sig- and operational procedures, and to rec- nature. ommend necessary changes in controls, Public key means the key of a key policies, or procedures. pair that is used to verify a digital sig- Token means something a person pos- nature. The public key is made avail- sesses and controls (typically a key or able to anyone who will receive password) used to authenticate the per- digitally signed messages from the son’s identity. holder of the key pair. Trusted agent means an entity au- Public Key Infrastructure (PKI) means thorized to act as a representative of a a structure under which a certification certification authority or credential authority verifies the identity of appli- service provider in confirming practi- cants; issues, renews, and revokes dig- tioner identification during the enroll- ital certificates; maintains a registry ment process. of public keys; and maintains an up-to- Valid prescription means a prescrip- date certificate revocation list. tion that is issued for a legitimate Readily retrievable means that certain medical purpose by an individual prac- records are kept by automatic data titioner licensed by law to administer processing applications or other elec- and prescribe the drugs concerned and tronic or mechanized recordkeeping acting in the usual course of the prac- systems in such a manner that they titioner’s professional practice. can be separated out from all other WebTrust means a professional serv- records in a reasonable time and/or ice performed by a qualified certified records are kept on which certain public accountant to evaluate one or items are asterisked, redlined, or in more aspects of Web sites. some other manner visually identifi- able apart from other items appearing [75 FR 16304, Mar. 31, 2010] on the records. SAS 70 Audit means a third-party § 1300.04 Definitions relating to the audit of a technology provider that dispensing of controlled substances by means of the Internet. meets the American Institute of Cer- tified Public Accountants (AICPA) (a) Any term not defined in this part Statement of Auditing Standards or elsewhere in this chapter shall have (SAS) 70 criteria. the definition set forth in sections 102 Signing function means any keystroke and 309 of the Act (21 U.S.C. 802, 829). or other action used to indicate that (b) The term covering practitioner the practitioner has authorized for means, with respect to a patient, a transmission and dispensing a con- practitioner who conducts a medical trolled substance prescription. The evaluation (other than an in-person signing function may occur simulta- medical evaluation) at the request of a neously with or after the completion of practitioner who: the two-factor authentication protocol (1) Has conducted at least one in-per- that meets the requirements of part son medical evaluation of the patient 1311 of this chapter. The signing func- or an evaluation of the patient through

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the practice of telemedicine, within purpose within the usual course of pro- the previous 24 months; and fessional practice. (2) Is temporarily unavailable to con- (g) The term Internet means collec- duct the evaluation of the patient. tively the myriad of computer and (c) The term deliver, distribute, or dis- telecommunications facilities, includ- pense by means of the Internet refers, re- ing equipment and operating software, spectively, to any delivery, distribu- which comprise the interconnected tion, or dispensing of a controlled sub- worldwide network of networks that stance that is caused or facilitated by employ the Transmission Control Pro- means of the Internet. tocol/Internet Protocol, or any prede- (d) The term filling new prescriptions cessor or successor protocol to such for controlled substances in Schedule III, protocol, to communicate information IV, or V means filling a prescription for of all kinds by wire or radio. an individual for a controlled sub- (h) The term online pharmacy means a stance in Schedule III, IV, or V, if: person, entity, or Internet site, wheth- (1) The pharmacy dispensing that er in the United States or abroad, that prescription has previously dispensed knowingly or intentionally delivers, to the patient a controlled substance distributes, or dispenses, or offers or other than by means of the Internet attempts to deliver, distribute, or dis- and pursuant to the valid prescription pense, a controlled substance by means of a practitioner that meets the appli- of the Internet. The term includes, but cable requirements of subsections (b) is not limited to, a pharmacy that has and (c) of section 309 of the Act (21 obtained a modification of its registra- U.S.C. 829) and §§ 1306.21 and 1306.22 of tion pursuant to §§ 1301.13 and 1301.19 of this chapter (for purposes of this defi- this chapter that currently authorizes nition, such a prescription shall be re- it to dispense controlled substances by ferred to as the ‘‘original prescrip- means of the Internet, regardless of tion’’); whether the pharmacy is currently dis- (2) The pharmacy contacts the prac- pensing controlled substances by titioner who issued the original pre- means of the Internet. The term does scription at the request of that indi- not include: vidual to determine whether the prac- (1) Manufacturers or distributors reg- titioner will authorize the issuance of a istered under subsection (a), (b), (d), or new prescription for that individual for (e) of section 303 of the Act (21 U.S.C. the controlled substance described in paragraph (d)(1) of this section (i.e., the 823(a), (b), (d), or (e)) (§ 1301.13 of this same controlled substance as described chapter) who do not dispense con- in paragraph (d)(1)); and trolled substances to an unregistered (3) The practitioner, acting in the individual or entity; usual course of professional practice, (2) Nonpharmacy practitioners who determines there is a legitimate med- are registered under section 303(f) of ical purpose for the issuance of the new the Act (21 U.S.C. 823(f)) (§ 1301.13 of prescription. this chapter) and whose activities are (e) The term homepage means the authorized by that registration; opening or main page or screen of the (3) Any hospital or other medical fa- Web site of an online pharmacy that is cility that is operated by an agency of viewable on the Internet. the United States (including the Armed (f) The term in-person medical evalua- Forces), provided such hospital or tion means a medical evaluation that is other facility is registered under sec- conducted with the patient in the phys- tion 303(f) of the Act (21 U.S.C. 823(f)) ical presence of the practitioner, with- (§ 1301.13 of this chapter); out regard to whether portions of the (4) A health care facility owned or evaluation are conducted by other operated by an Indian tribe or tribal health professionals. Nothing in this organization, only to the extent such paragraph shall be construed to imply facility is carrying out a contract or that one in-person medical evaluation compact under the Indian Self-Deter- demonstrates that a prescription has mination and Education Assistance been issued for a legitimate medical Act;

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(5) Any agent or employee of any hos- in a long term care facility when the pital or facility referred to in para- registration of the automated dis- graph (h)(3) or (h)(4) of this section, pensing system is held by that phar- provided such agent or employee is macy as described in §§ 1301.17 and lawfully acting in the usual course of 1301.27 and the pharmacy is otherwise business or employment, and within complying with this chapter. the scope of the official duties of such (ii) A registered pharmacy will be agent or employee, with such hospital deemed to meet this exception if, in or facility, and, with respect to agents view of all of its activities other than or employees of health care facilities those referred to in paragraph (h)(10)(i) specified in paragraph (h)(4) of this sec- of this section, it would fall outside the tion, only to the extent such individ- definition of an online pharmacy. uals are furnishing services pursuant (i) Effective January 15, 2010, the to the contracts or compacts described term practice of telemedicine means the in such paragraph; practice of medicine in accordance (6) Mere advertisements that do not with applicable Federal and State laws attempt to facilitate an actual trans- by a practitioner (other than a phar- action involving a controlled sub- macist) who is at a location remote stance; from the patient and is communicating (7) A person, entity, or Internet site with the patient, or health care profes- that is not in the United States and sional who is treating the patient, does not facilitate the delivery, dis- using a telecommunications system re- tribution, or dispensing of a controlled ferred to in section 1834(m) of the So- substance by means of the Internet to cial Security Act (42 U.S.C. 1395m(m)), any person in the United States; which practice falls within a category (8) A pharmacy registered under sec- listed in the following paragraphs (i)(1) tion 303(f) of the Act (21 U.S.C. 823(f)) through (7): (§ 1301.13 of this chapter) whose dis- (1) Treatment in a hospital or clinic. pensing of controlled substances via The practice of telemedicine is being the Internet consists solely of: (i) Refilling prescriptions for con- conducted while the patient is being trolled substances in Schedule III, IV, treated by, and physically located in, a or V, as defined in paragraph (k) of this hospital or clinic registered under sec- section; or tion 303(f) of the Act (21 U.S.C. 823(f)) (ii) Filling new prescriptions for con- by a practitioner acting in the usual trolled substances in Schedule III, IV, course of professional practice, who is or V, as defined in paragraph (d) of this acting in accordance with applicable section; State law, and who is registered under (9)(i) Any registered pharmacy whose section 303(f) of the Act (21 U.S.C. delivery, distribution, or dispensing of 823(f)) in the State in which the patient controlled substances by means of the is located, unless the practitioner: Internet consists solely of filling pre- (i) Is exempted from such registra- scriptions that were electronically pre- tion in all States under section 302(d) scribed in a manner authorized by this of the Act (21 U.S.C. 822(d); or chapter and otherwise in compliance (ii) Is an employee or contractor of with the Act. the Department of Veterans Affairs (ii) A registered pharmacy will be who is acting in the scope of such em- deemed to meet this exception if, in ployment or contract, and registered view of all of its activities other than under section 303(f) of the Act (21 those referred to in paragraph (h)(9)(i) U.S.C. 823(f)) in any State or is uti- of this section, it would fall outside the lizing the registration of a hospital or definition of an online pharmacy; or clinic operated by the Department of (10)(i) Any registered pharmacy Veterans Affairs registered under sec- whose delivery, distribution, or dis- tion 303(f); pensing of controlled substances by (2) Treatment in the physical presence means of the Internet consists solely of of a practitioner. The practice of tele- the transmission of prescription infor- medicine is being conducted while the mation between a pharmacy and an patient is being treated by, and in the automated dispensing system located physical presence of, a practitioner

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acting in the usual course of profes- under section 311(h) of the Act (21 sional practice, who is acting in ac- U.S.C. 831(h)); cordance with applicable State law, (6) Department of Veterans Affairs med- and who is registered under section ical emergency. The practice of tele- 303(f) of the Act (21 U.S.C. 823(f)) in the medicine is being conducted: State in which the patient is located, (i) In a medical emergency situation: unless the practitioner: (A) That prevents the patient from (i) Is exempted from such registra- being in the physical presence of a tion in all States under section 302(d) practitioner registered under section of the Act (21 U.S.C. 822(d)); or 303(f) of the Act (21 U.S.C. 823(f)) who is (ii) Is an employee or contractor of an employee or contractor of the Vet- the Department of Veterans Affairs erans Health Administration acting in who is acting in the scope of such em- the usual course of business and em- ployment or contract, and registered ployment and within the scope of the under section 303(f) of the Act (21 official duties or contract of that em- U.S.C. 823(f)) in any State or is using ployee or contractor; the registration of a hospital or clinic (B) That prevents the patient from operated by the Department of Vet- being physically present at a hospital erans Affairs registered under section or clinic operated by the Department 303(f); of Veterans Affairs registered under (3) Indian Health Service or tribal orga- section 303(f) of the Act (21 U.S.C. nization. The practice of telemedicine 823(f)); is being conducted by a practitioner (C) During which the primary care who is an employee or contractor of practitioner of the patient or a practi- the Indian Health Service, or is work- tioner otherwise practicing telemedi- ing for an Indian tribe or tribal organi- cine within the meaning of this para- zation under its contract or compact graph is unable to provide care or con- with the Indian Health Service under sultation; and the Indian Self-Determination and (D) That requires immediate inter- Education Assistance Act; who is act- vention by a health care practitioner ing within the scope of the employ- using controlled substances to prevent ment, contract, or compact; and who is what the practitioner reasonably be- designated as an Internet Eligible Con- lieves in good faith will be imminent trolled Substances Provider by the Sec- and serious clinical consequences, such retary of Health and Human Services as further injury or death; and under section 311(g)(2) of the Act (21 (ii) By a practitioner that: U.S.C. 831(g)(2)); (A) Is an employee or contractor of (4) Public health emergency declared by the Veterans Health Administration the Secretary of Health and Human Serv- acting within the scope of that employ- ices. The practice of telemedicine is ment or contract; being conducted during a public health (B) Is registered under section 303(f) emergency declared by the Secretary of the Act (21 U.S.C. 823(f)) in any State of Health and Human Services under or is utilizing the registration of a hos- section 319 of the Public Health Service pital or clinic operated by the Depart- Act (42 U.S.C. 247d), and involves pa- ment of Veterans Affairs registered tients located in such areas, and such under section 303(f); and controlled substances, as the Secretary (C) Issues a controlled substance pre- of Health and Human Services, with scription in this emergency context the concurrence of the Administrator, that is limited to a maximum of a five- designates, provided that such designa- day supply which may not be extended tion shall not be subject to the proce- or refilled; or dures prescribed by the Administrative (7) Other circumstances specified by reg- Procedure Act (5 U.S.C. 551–559 and 701– ulation. The practice of telemedicine is 706); being conducted under any other cir- (5) Special registration. The practice of cumstances that the Administrator telemedicine is being conducted by a and the Secretary of Health and practitioner who has obtained from the Human Services have jointly, by regu- Administrator a special registration lation, determined to be consistent

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with effective controls against diver- § 1300.05 Definitions relating to the sion and otherwise consistent with the disposal of controlled substances. public health and safety. (a) Any term not defined in this part (j) Temporary definition of practice of or elsewhere in this chapter shall have telemedicine. Prior to January 15, 2010, the definition set forth in section 102 of or as otherwise specified by regulation the Act (21 U.S.C. 802). prior to that date, instead of the defini- (b) As used in part 1317 of this chap- tion in paragraph (i), the term practice ter, the following terms shall have the of telemedicine means the practice of meanings specified: medicine in accordance with applicable Employee means an employee as de- Federal and State laws by a practi- fined under the general common law of tioner (as that term is defined in sec- agency. Some of the factors relevant to tion 102 of the Act (21 U.S.C. 802)) the determination of employee status (other than a pharmacist) who is at a include: The hiring party’s right to location remote from the patient and is control the manner and means by communicating with the patient, or which the product is accomplished; the health care professional who is treat- skill required; the source of the instru- ing the patient, using a telecommuni- mentalities and tools; the location of cations system referred to in section the work; the duration of the relation- 1834(m) of the Social Security Act (42 ship between the parties; whether the U.S.C. 1395m(m)), if the practitioner is hiring party has the right to assign ad- using an interactive telecommuni- ditional projects to the hired party; the cations system that satisfies the re- extent of the hired party’s discretion quirements of section 410.78(a)(3) of over when and how long to work; the title 42, Code of Federal Regulations. method of payment; the hired party’s (k) The term refilling prescriptions for role in hiring and paying assistants; controlled substances in Schedule III, IV, whether the work is part of the regular or V: business of the hiring party; whether (1) Means the dispensing of a con- the hiring party is in business; the pro- trolled substance in Schedule III, IV, or vision of employee benefits; and the V in accordance with refill instructions tax treatment of the hired party. Other issued by a practitioner as part of a applicable factors may be considered valid prescription that meets the re- and no one factor is dispositive. The quirements of subsections (b) and (c) of following criteria will determine section 309 of the Act (21 U.S.C. 829) whether a person is an employee of a and §§ 1306.21 and 1306.22 of this chapter, registrant for the purpose of disposal: as appropriate; and The person is directly paid by the reg- (2) Does not include the issuance of a istrant; subject to direct oversight by new prescription to an individual for a the registrant; required, as a condition controlled substance that individual of employment, to follow the reg- was previously prescribed. istrant’s procedures and guidelines per- (l)(1) The term valid prescription taining to the handling of controlled means a prescription that is issued for substances; subject to receive a per- a legitimate medical purpose in the formance rating or performance eval- usual course of professional practice uation on a regular/routine basis from by: the registrant; subject to disciplinary (i) A practitioner who has conducted action by the registrant; and required at least one in-person medical evalua- to render services at the registrant’s tion of the patient; or registered location. (ii) A covering practitioner. Law enforcement officer means a per- (2) Nothing in this paragraph (l) shall son who is described in paragraph (1), be construed to imply that one in-per- (2) or (3) of this definition: (1) Meets all of the following criteria: son medical evaluation demonstrates (i) Employee of either a law enforce- that a prescription has been issued for ment agency, or law enforcement com- a legitimate medical purpose within ponent of a Federal agency; the usual course of professional prac- (ii) Is under the direction and control tice. of a Federal, State, tribal, or local gov- [74 FR 15619, Apr. 6, 2009] ernment;

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(iii) Acting in the course of his/her PART 1301—REGISTRATION OF official duty; and MANUFACTURERS, DISTRIBUTORS, (iv) Duly sworn and given the author- AND DISPENSERS OF CON- ity by a Federal, State, tribal, or local TROLLED SUBSTANCES government to carry firearms, execute and serve warrants, make arrests with- GENERAL INFORMATION out warrant, and make seizures of Sec. property; 1301.01 Scope of this part 1301. (2) Is a Veterans Health Administra- 1301.02 Definitions. tion (VHA) police officer authorized by 1301.03 Information; special instructions. the Department of Veterans Affairs to REGISTRATION participate in collection activities con- ducted by the VHA; or 1301.11 Persons required to register; require- (3) Is a Department of Defense (DOD) ment of modification of registration au- thorizing activity as an online phar- police officer authorized by the DOD to macy. participate in collection activities con- 1301.12 Separate registrations for separate ducted by the DOD. locations. Non-retrievable means, for the purpose 1301.13 Application for registration; time of destruction, the condition or state for application; expiration date; registra- tion for independent activities; applica- to which a controlled substance shall tion forms, fees, contents and signature; be rendered following a process that coincident activities. permanently alters that controlled 1301.14 Filing of application; acceptance for substance’s physical or chemical condi- filing; defective applications. tion or state through irreversible 1301.15 Additional information. 1301.16 Amendments to and withdrawal of means and thereby renders the con- applications. trolled substance unavailable and un- 1301.17 Special procedures for certain appli- usable for all practical purposes. The cations. process to achieve a non-retrievable 1301.18 Research protocols. condition or state may be unique to a 1301.19 Special requirements for online substance’s chemical or physical prop- pharmacies. erties. A controlled substance is con- EXCEPTIONS TO REGISTRATION AND FEES sidered ‘‘non-retrievable’’ when it can- 1301.21 Exception from fees. not be transformed to a physical or 1301.22 Exemption of agents and employees; chemical condition or state as a con- affiliated practitioners. trolled substance or controlled sub- 1301.23 Exemption of certain military and stance analogue. The purpose of de- other personnel. struction is to render the controlled 1301.24 Exemption of law enforcement offi- cials. substance(s) to a non-retrievable state 1301.25 Registration regarding ocean ves- and thus prevent diversion of any such sels, aircraft, and other entities. substance to illicit purposes. 1301.26 Exemptions from import or export On-site means located on or at the requirements for personal medical use. physical premises of the registrant’s 1301.27 Separate registration by retail phar- macies for installation and operation of registered location. A controlled sub- automated dispensing systems at long stance is destroyed on-site when de- term care facilities. struction occurs on the physical prem- 1301.28 Exemption from separate registra- ises of the destroying registrant’s reg- tion for practitioners dispensing or pre- istered location. A hospital/clinic has scribing Schedule III, IV, or V narcotic an on-site pharmacy when it has a phar- controlled drugs approved by the Food and Drug Administration specifically for macy located on the physical premises use in maintenance or detoxification of the registrant’s registered location. treatment. 1301.29 [Reserved] [79 FR 53560, Sept. 9, 2014] ACTION ON APPLICATION FOR REGISTRATION: REVOCATION OR SUSPENSION OF REGISTRATION 1301.31 Administrative review generally. 1301.32 Action on applications for research in Schedule I substances.

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