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) boldione (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 hallucinogen, 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 medication 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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