PART 1300—DEFINITIONS Authority: 21 U.S.C. 802, 821, 822, 823, 829, 871(b), 951, 958(f). Source: 62 FR 13941, Mar. 24, 1997, unless otherwise noted. § 1300.01 Definitions relating to controlled substances. (a) Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802), except that certain terms used in part 1316 of this chapter are defined at the beginning of each subpart of that part. (b) As used in parts 1301 through 1308, 1312, and 1317 of this chapter, the following terms shall have the meanings specified: Act Administration Administrator Anabolic steroid (1)(i) Except as provided in paragraph (1)(ii) of this definition, such term does not include an anabolic steroid that is expressly intended for administration through implants to cattle or other nonhuman species and that has been approved by the Secretary of Health and Human Services for such administration. (ii) If any person prescribes, dispenses, or distributes such steroid for human use, the person shall be considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of this definition. (2)(i) Subject to paragraph (2)(ii) of this definition, a drug or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed in § 1308.13(f) of this chapter and is derived from, or has a chemical structure substantially similar to, one or more anabolic steroids listed in § 1308.13(f) of this chapter shall be considered to be an anabolic steroid for purposes of this chapter if— (A) The drug or substance has been created or manufactured with the intent of producing a drug or other substance that either— ( 1 ( 2 (B) The drug or substance has been, or is intended to be, marketed or otherwise promoted in any manner suggesting that consuming it will promote muscle growth or any other pharmacological effect similar to that of testosterone. (ii) A substance shall not be considered to be a drug or hormonal substance for purposes of this definition if it— (A) Is— ( 1 ( 2 ( 3 1 2 (B) Is a dietary ingredient for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq. (C) Is not anabolic or androgenic. (iii) In accordance with 21 U.S.C. 885(a), any person claiming the benefit of an exemption or exception under paragraph (2)(ii) of this definition shall bear the burden of going forward with the evidence with respect to such exemption or exception. Automated dispensing system Basic class (1) Each of the opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, listed in § 1308.11(b) of this chapter; (2) Each of the opium derivatives, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in § 1308.11(c) of this chapter; (3) Each of the hallucinogenic substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in § 1308.11(d) of this chapter; (4) Each of the following substances, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis: (i) Opium, including raw opium, opium extracts, opium fluid extracts, powdered opium, granulated opium, deodorized opium and tincture of opium; (ii) Apomorphine; (iii) Codeine; (iv) Etorphine hydrochloride; (v) Ethylmorphine; (vi) Hydrocodone; (vii) Hydromorphone; (viii) Metopon; (ix) Morphine; (x) Oxycodone; (xi) Oxymorphone; (xii) Thebaine; (xiii) Mixed alkaloids of opium listed in § 1308.12(b)(2) of this chapter; (xiv) Cocaine; and (xv) Ecgonine; (5) Each of the opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, listed in § 1308.12(c) of this chapter; and (6) Methamphetamine, its salts, isomers, and salts of its isomers; (7) Amphetamine, its salts, optical isomers, and salts of its optical isomers; (8) Phenmetrazine and its salts; (9) Methylphenidate; (10) Each of the substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in § 1308.12(e) of this chapter. Central fill pharmacy Collection collector Commercial container Competent national authority, Compounder Controlled substance Customs officer Customs territory of the United States Detoxification treatment (1) Short-term detoxification treatment is for a period not in excess of 30 days. (2) Long-term detoxification treatment is for a period more than 30 days but not in excess of 180 days. Dispenser Export Exporter Freight forwarding facility i.e. Hearing (1) In part 1301 of this chapter, any hearing held for the granting, denial, revocation, or suspension of a registration pursuant to sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958). (2) In part 1303 of this chapter, any hearing held regarding the determination of aggregate production quota or the issuance, adjustment, suspension, or denial of a procurement quota or an individual manufacturing quota. (3) In part 1308 of this chapter, any hearing held for the issuance, amendment, or repeal of any rule issuable pursuant to section 201 of the Act (21 U.S.C. 811). Import Importer Individual practitioner Institutional practitioner Interested person Inventory Isomer (1) The optical isomer, except as used in § 1308.11(d) and § 1308.12(b)(4) of this chapter. As used in § 1308.11(d) of this chapter, the term “isomer” means any optical, positional, or geometric isomer. As used in § 1308.12(b)(4) of this chapter, the term “isomer” means any optical or geometric isomer; (2) As used in § 1308.11(d) of this chapter, the term “positional isomer” means any substance possessing the same molecular formula and core structure and having the same functional group(s) and/or substituent(s) as those found in the respective Schedule I hallucinogen, attached at any position(s) on the core structure, but in such manner that no new chemical functionalities are created and no existing chemical functionalities are destroyed relative to the respective Schedule I hallucinogen. Rearrangements of alkyl moieties within or between functional group(s) or substituent(s), or divisions or combinations of alkyl moieties, that do not create new chemical functionalities or destroy existing chemical functionalities, are allowed i.e., result in compounds which are positional isomers. For purposes of this definition, the “core structure” is the parent molecule that is the common basis for the class; for example, tryptamine, phenethylamine, or ergoline. Examples of rearrangements resulting in creation and/or destruction of chemical functionalities (and therefore resulting in compounds which are not positional isomers) include, but are not limited to: Ethoxy to alpha Tert sec alpha Label Labeling (1) Upon any controlled substance or any of its commercial containers or wrappers, or (2) Accompanying such controlled substance. Long Term Care Facility (LTCF) Maintenance treatment Manufacture Manufacturer Marijuana Mid-level practitioner Mobile Narcotic Treatment Program Motor vehicle Name Narcotic drug (1) Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium. (2) Poppy straw and concentrate of poppy straw. (3) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine and derivatives of ecgonine or their salts have been removed. (4) Cocaine, its salts, optical and geometric isomers, and salts of isomers. (5) Ecgonine, its derivatives, their salts, isomers and salts of isomers. (6) Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in paragraphs (1) through (5) of this definition. Narcotic treatment program Net disposal Person Pharmacist Port of entry Code of Federal Regulations Port of export Prescription Proceeding Federal Register. Purchaser Qualified practitioner (1) Is licensed under State law to prescribe controlled substances; and (2) Is not solely a veterinarian. Readily retrievable Register registration Registrant Return information Reverse distribute (1) Return to the registered manufacturer or another registrant authorized by the manufacturer to accept returns on the manufacturer's behalf; or (2) Destruction. Reverse distributor State medical marijuana license Supplier United States, [62 FR 13941, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 68 FR 37409, June 24, 2003; 68 FR 41228, July 11, 2003; 70 FR 25465, May 13, 2005; 70 FR 74656, Dec. 16, 2005; 71 FR 60427, Oct. 13, 2006; 72 FR 67852, Dec. 3, 2007; 74 FR 63609, Dec. 4, 2009; 77 FR 4230, Jan. 27, 2012; 77 FR 44461, July 30, 2012; 79 FR 53559, Sept. 9, 2014; 81 FR 97018, Dec. 30, 2016; 86 FR 33883, June 28, 2021; 88 FR 50039, Aug. , 2023; 91 FR 22721, Apr. 28, 2026; 91 FR 34767, June 9, 2026] § 1300.02 Definitions relating to listed chemicals. (a) Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802), except that certain terms used in part 1316 of this chapter are defined at the beginning of each subpart of that part. (b) As used in parts 1309, 1310, and 1313 of this chapter, the following terms shall have the meaning specified: Act Administration Administrator At retail, Broker trader (1) Negotiating contracts; (2) Serving as an agent or intermediary; or (3) Fulfilling a formal obligation to complete the transaction by bringing together a buyer and seller, a buyer and transporter, or a seller and transporter, or by receiving any form of compensation for so doing. Chemical export Chemical exporter Chemical importer Chemical mixture Combination ephedrine product Competent national authority, Customs officer Customs territory of the United States Drug product Encapsulating machine Established business relationship Established record as an importer Export Hearing Import International transaction Listed chemical List I chemical List II chemical Mobile retail vendor Name Person Port of entry, Code of Federal Regulations Port of export Readily retrievable Register registration Registrant Regular customer Regular importer Regulated person Regulated seller Regulated transaction (1) A distribution, receipt, sale, importation, or exportation of a listed chemical, or an international transaction involving shipment of a listed chemical, or if the Administrator establishes a threshold amount for a specific listed chemical, a threshold amount as determined by the Administrator, which includes a cumulative threshold amount for multiple transactions, of a listed chemical, except that such term does not include: (i) A domestic lawful distribution in the usual course of business between agents or employees of a single regulated person; in this context, agents or employees means individuals under the direct management and control of the regulated person; (ii) A delivery of a listed chemical to or by a common or contract carrier for carriage in the lawful and usual course of the business of the common or contract carrier, or to or by a warehouseman for storage in the lawful and usual course of the business of the warehouseman, except that if the carriage or storage is in connection with the distribution, importation, or exportation of a listed chemical to a third person, this paragraph does not relieve a distributor, importer, or exporter from compliance with parts 1309, 1310, 1313, and 1315 of this chapter; (iii) Any category of transaction or any category of transaction for a specific listed chemical or chemicals specified by regulation of the Administrator as excluded from this definition as unnecessary for enforcement of the Act; (iv) Any transaction in a listed chemical that is contained in a drug other than a scheduled listed chemical product that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act, subject to paragraph (1)(v) of this definition, unless— (A) The Administrator has determined pursuant to the criteria in § 1310.10 of this chapter that the drug or group of drugs is being diverted to obtain the listed chemical for use in the illicit production of a controlled substance; and (B) The quantity of the listed chemical contained in the drug included in the transaction or multiple transactions equals or exceeds the threshold established for that chemical; (v) Any transaction in a scheduled listed chemical product that is a sale at retail by a regulated seller or a distributor required to submit reports under § 1310.03(c) of this chapter; or (vi) Any transaction in a chemical mixture designated in §§ 1310.12 and 1310.13 of this chapter that the Administrator has exempted from regulation. (2) A distribution, importation, or exportation of a tableting machine or encapsulating machine except that such term does not include a domestic lawful distribution in the usual course of business between agents and employees of a single regulated person; in this context, agents or employees means individuals under the direct management and control of the regulated person. Retail distributor Return information Scheduled listed chemical product (1) A product that contains ephedrine, pseudoephedrine, or phenylpropanolamine and may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act as a nonprescription drug. Ephedrine, pseudoephedrine, and phenylpropanolamine include their salts, optical isomers, and salts of optical isomers. (2) Scheduled listed chemical product does not include any product that is a controlled substance under part 1308 of this chapter. In the absence of such scheduling by the Attorney General, a chemical specified in paragraph (1) of this definition may not be considered to be a controlled substance. Tableting machine United States, Valid prescription [75 FR 16304, Mar. 31, 2010, as amended at 77 FR 4233, Jan. 27, 2012; 81 FR 97019, Dec. 30, 2016; 85 FR 68461, Oct. 29, 2020] § 1300.03 Definitions relating to electronic orders for controlled substances and electronic prescriptions for controlled substances. For the purposes of this chapter, the following terms shall have the meanings specified: Application service provider Audit trail Authentication Authentication protocol Biometric authentication Biometric subsystem (1) Capturing a biometric sample from an end user. (2) Extracting and processing the biometric data from that sample. (3) Storing the extracted information in a database. (4) Comparing the biometric data with data contained in one or more reference databases. (5) Determining how well the stored data matches the newly captured data and indicating whether an identification or verification of identity has been achieved. Cache Certificate policy Certificate revocation list (CRL) Certification authority (CA) Certified information systems auditor (CISA) Credential Credential service provider (CSP) CSOS Digital certificate (1) Identifies the certification authority issuing it; (2) Names or otherwise identifies the certificate holder; (3) Contains a public key that corresponds to a private key under the sole control of the certificate holder; (4) Identifies the operational period; and (5) Contains a serial number and is digitally signed by the certification authority issuing it. Digital signature Digitally sign Electronic prescription Electronic prescription application provider Electronic signature False match rate False non-match rate FIPS FIPS 140-2, FIPS 180-2, FIPS 180-3, FIPS 186-2, FIPS 186-3, Hard token Identity proofing Installed electronic prescription application Installed pharmacy application Intermediary Key pair (1) One key can be used to encrypt a message that can only be decrypted using the other key; and (2) Even knowing one key, it is computationally infeasible to discover the other key. NIST NIST SP 800-63-1, NIST SP 800-76-1, Operating point Paper prescription Password PDA Pharmacy application provider Private key Public key Public Key Infrastructure (PKI) Readily retrievable SAS 70 Audit Signing function SysTrust Third-party audit Token Trusted agent Valid prescription WebTrust [75 FR 16304, Mar. 31, 2010] § 1300.04 Definitions relating to the dispensing of controlled substances by means of the Internet. (a) Any term not defined in this part or elsewhere in this chapter shall have the definition set forth in sections 102 and 309 of the Act (21 U.S.C. 802, 829). (b) The term covering practitioner (1) Has conducted at least one in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and (2) Is temporarily unavailable to conduct the evaluation of the patient. (c) The term deliver, distribute, or dispense by means of the Internet (d) The term filling new prescriptions for controlled substances in Schedule III, IV, or V (1) The pharmacy dispensing that prescription has previously dispensed to the patient a controlled substance other than by means of the Internet and pursuant to the valid prescription of a practitioner that meets the applicable requirements of subsections (b) and (c) of section 309 of the Act (21 U.S.C. 829) and §§ 1306.21 and 1306.22 of this chapter (for purposes of this definition, such a prescription shall be referred to as the “original prescription”); (2) The pharmacy contacts the practitioner who issued the original prescription at the request of that individual to determine whether the practitioner will authorize the issuance of a new prescription for that individual for the controlled substance described in paragraph (d)(1) of this section ( i.e. (3) The practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription. (e) The term homepage (f) The term in-person medical evaluation (g) The term Internet (h) The term online pharmacy (1) Manufacturers or distributors registered under subsection (a), (b), (d), or (e) of section 303 of the Act (21 U.S.C. 823(a), (b), (d), or (e)) (§ 1301.13 of this chapter) who do not dispense controlled substances to an unregistered individual or entity; (2) Nonpharmacy practitioners who are registered under section 303(f) of the Act (21 U.S.C. 823(f)) (§ 1301.13 of this chapter) and whose activities are authorized by that registration; (3) Any hospital or other medical facility that is operated by an agency of the United States (including the Armed Forces), provided such hospital or other facility is registered under section 303(f) of the Act (21 U.S.C. 823(f)) (§ 1301.13 of this chapter); (4) A health care facility owned or operated by an Indian tribe or tribal organization, only to the extent such facility is carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act; (5) Any agent or employee of any hospital or facility referred to in paragraph (h)(3) or (h)(4) of this section, provided such agent or employee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee, with such hospital or facility, and, with respect to agents or employees of health care facilities specified in paragraph (h)(4) of this section, only to the extent such individuals are furnishing services pursuant to the contracts or compacts described in such paragraph; (6) Mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance; (7) A person, entity, or Internet site that is not in the United States and does not facilitate the delivery, distribution, or dispensing of a controlled substance by means of the Internet to any person in the United States; (8) A pharmacy registered under section 303(f) of the Act (21 U.S.C. 823(f)) (§ 1301.13 of this chapter) whose dispensing of controlled substances via the Internet consists solely of: (i) Refilling prescriptions for controlled substances in Schedule III, IV, or V, as defined in paragraph (k) of this section; or (ii) Filling new prescriptions for controlled substances in Schedule III, IV, or V, as defined in paragraph (d) of this section; (9)(i) Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by means of the Internet consists solely of filling prescriptions that were electronically prescribed in a manner authorized by this chapter and otherwise in compliance with the Act. (ii) A registered pharmacy will be deemed to meet this exception if, in view of all of its activities other than those referred to in paragraph (h)(9)(i) of this section, it would fall outside the definition of an online pharmacy; or (10)(i) Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by means of the Internet consists solely of the transmission of prescription information between a pharmacy and an automated dispensing system located in a long term care facility when the registration of the automated dispensing system is held by that pharmacy as described in §§ 1301.17 and 1301.27 and the pharmacy is otherwise complying with this chapter. (ii) A registered pharmacy will be deemed to meet this exception if, in view of all of its activities other than those referred to in paragraph (h)(10)(i) of this section, it would fall outside the definition of an online pharmacy. (i) Effective January 15, 2010, the term practice of telemedicine (1) Treatment in a hospital or clinic. (i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C. 822(d); or (ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f); (2) Treatment in the physical presence of a practitioner. (i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C. 822(d)); or (ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is using the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f); (3) Indian Health Service or tribal organization. (4) Public health emergency declared by the Secretary of Health and Human Services. (5) Special registration. (6) Department of Veterans Affairs medical emergency. (i) In a medical emergency situation: (A) That prevents the patient from being in the physical presence of a practitioner registered under section 303(f) of the Act (21 U.S.C. 823(f)) who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employment and within the scope of the official duties or contract of that employee or contractor; (B) That prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f) of the Act (21 U.S.C. 823(f)); (C) During which the primary care practitioner of the patient or a practitioner otherwise practicing telemedicine within the meaning of this paragraph is unable to provide care or consultation; and (D) That requires immediate intervention by a health care practitioner using controlled substances to prevent what the practitioner reasonably believes in good faith will be imminent and serious clinical consequences, such as further injury or death; and (ii) By a practitioner that: (A) Is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract; (B) Is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f); and (C) Issues a controlled substance prescription in this emergency context that is limited to a maximum of a five-day supply which may not be extended or refilled; or (7) Other circumstances specified by regulation. (j) Temporary definition of practice of telemedicine. practice of telemedicine (k) The term refilling prescriptions for controlled substances in Schedule III, IV, or V: (1) Means the dispensing of a controlled substance in Schedule III, IV, or V in accordance with refill instructions issued by a practitioner as part of a valid prescription that meets the requirements of subsections (b) and (c) of section 309 of the Act (21 U.S.C. 829) and §§ 1306.21 and 1306.22 of this chapter, as appropriate; and (2) Does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously prescribed. (l)(1) The term valid prescription (i) A practitioner who has conducted at least one in-person medical evaluation of the patient; or (ii) A covering practitioner. (2) Nothing in this paragraph (l) shall be construed to imply that one in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice. [74 FR 15619, Apr. 6, 2009] § 1300.05 Definitions relating to the disposal of controlled substances. (a) Any term not defined in this part or elsewhere in this chapter shall have the definition set forth in section 102 of the Act (21 U.S.C. 802). (b) As used in part 1317 of this chapter, the following terms shall have the meanings specified: Employee employee Law enforcement officer (1) Meets all of the following criteria: (i) Employee of either a law enforcement agency, or law enforcement component of a Federal agency; (ii) Is under the direction and control of a Federal, State, tribal, or local government; (iii) Acting in the course of his/her official duty; and (iv) Duly sworn and given the authority by a Federal, State, tribal, or local government to carry firearms, execute and serve warrants, make arrests without warrant, and make seizures of property; (2) Is a Veterans Health Administration (VHA) police officer authorized by the Department of Veterans Affairs to participate in collection activities conducted by the VHA; or (3) Is a Department of Defense (DOD) police officer authorized by the DOD to participate in collection activities conducted by the DOD. Non-retrievable On-site on-site on-site [79 FR 53560, Sept. 9, 2014] § 1300.06 Definitions relating to emergency medical services agencies. (a) Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802). (b) As used in parts 1301, 1304, 1306, and 1307 of this chapter, the following terms shall have the meanings specified: (1) Actively in use (2) Authorizing medical professional (i) Who is registered under 21 U.S.C. 823; (ii) Who is acting within the scope of the registration; and (iii) Whose scope of practice under a State license or certification includes the ability to provide verbal orders. (3) Designated location (4) Emergency medical services (5) Emergency medical services agency (i) Is governmental (including fire-based and hospital-based agencies), non-governmental (including hospital-based agencies), private, or volunteer-based; (ii) Provides emergency medical services by ground, air, or otherwise; and (iii) Is authorized by the State in which the organization is providing such services to provide emergency medical care, including the administering of controlled substances, to members of the general public on an emergency basis. (6) Emergency medical services professional (7) Emergency medical services vehicle (8) Hospital-based (9) Medical director (10) Medical oversight (11) On call (12) Registered emergency services agency (i) An emergency medical services agency that is registered under 21 U.S.C. 823(k); or (ii) A hospital-based emergency medical services agency that is covered by the registration of the hospital under subsection 823(g). (13) Registered location (14) Specific State authority (15) Standing order (16) Stationhouse (17) Verbal order [91 FR 5239, Feb. 5, 2026]