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Title 21 CFR reference

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United States • Title 21 CFR • Part 1300

Part 1300PART 1300—DEFINITIONS

Part 1300 of Title 21 CFR provides definitions for terms used in the regulation of controlled substances by the Drug Enforcement Administration (DEA). It clarifies terms related to the Controlled Substances Act and the Controlled Substances Import and Export Act, including definitions for various drug classifications, treatment modalities, and regulatory actions.

What this part covers

  • Defines terms used in parts 1301 through 1308, 1312, and 1317 of Title 21 CFR.
  • Clarifies definitions for 'Act', 'Administration', and 'Administrator' in the context of the DEA.
  • Provides specific definitions for 'Anabolic steroid', 'Basic class' of controlled substances, and 'Central fill pharmacy'.
  • Defines terms related to the handling and dispensing of controlled substances, such as 'Collectioncollector', 'Commercial container', 'Compounder', 'Dispenser', 'Exporter', and 'Importer'.
  • Includes definitions for treatment modalities like 'Detoxification treatment' (short-term and long-term) and 'Maintenance treatment'.
  • Defines 'Manufacture' and 'Manufacturer' in the context of controlled substances.
  • Specifies definitions for 'Narcotic drug' and 'Narcotic treatment program'.
  • Clarifies terms related to import and export activities, including 'Competent national authority' and 'Customs territory of the United States'.
  • Defines 'Isomer' with specific applications for different sections of the CFR.
  • Provides definitions for 'Label' and 'Labeling' concerning controlled substances.

Sections in Part 1300

§ 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 means the Controlled Substances Act, as amended (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951). Administration means the Drug Enforcement Administration. Administrator means the Administrator of the Drug Enforcement Administration. The Administrator has been delegated authority under the Act by the Attorney General (28 CFR 0.100). Anabolic steroid means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes: Automated dispensing system means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and…

§ 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 means the Controlled Substances Act, as amended (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951). Administration means the Drug Enforcement Administration. Administrator means the Administrator of the Drug Enforcement Administration. The Administrator has been delegated authority under the Act by the Attorney General (28 CFR 0.100). At retail, with respect to the sale or purchase of a scheduled listed chemical product, means a sale or purchase for personal use, respectively. Brokertrader and mean any individual, corporation, corporate division, partnership, association, or other legal entity which assists in arranging an international transaction in a listed chemical by— (1) Negotiating contracts; (2) Serving as an agent or intermediary; or (3)…

§ 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 means an entity that sells electronic prescription or pharmacy applications as a hosted service, where the entity controls access to the application and maintains the software and records on its servers. Audit trail means a record showing who has accessed an information technology application and what operations the user performed during a given period. Authentication means verifying the identity of the user as a prerequisite to allowing access to the information application. Authentication protocol means a well specified message exchange process that verifies possession of a token to remotely authenticate a person to an application. Biometric authentication means authentication based on measurement of the individual's physical features or repeatable actions where those features or actions are both distinctive to the individual and measurable. Biometric subsystem means the hardware and software used to capture, store, and compare biometric data. The biometric subsystem may be part of a larger application. The biometric subsystem is an automated system capable…

§ 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). covering practitioner(b) The term means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who: (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. deliver, distribute, or dispense by means of the Internet(c) The term refers, respectively, to any delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the Internet. filling new prescriptions for controlled substances in Schedule III, IV, or V(d) The term means filling a prescription for an individual for a controlled substance in Schedule III, IV, or V, if: (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…

§ 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: Employeeemployee means an employee as defined under the general common law of agency. Some of the factors relevant to the determination of employee status include: The hiring party's right to control the manner and means by which the product is accomplished; the skill required; the source of the instrumentalities and tools; the location of the work; the duration of the relationship between the parties; whether the hiring party has the right to assign additional projects to the hired party; the extent of the hired party's discretion over when and how long to work; the method of payment; the hired party's role in hiring and paying assistants; whether the work is part of the regular business of the hiring party; whether the hiring party is in business; the provision of employee benefits; and the tax treatment of the hired party. Other applicable factors may be considered and no one factor is dispositive. The following criteria will determine…

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This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.

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