Persons registered by the Attorney General under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals are authorized to possess, manufacture, distribute, or dispense such substances or chemicals (including any such activity in the conduct of research) to the extent authorized by their registration and in conformity with the other provisions of this subchapter.
The following persons shall not be required to register and may lawfully possess any controlled substance or list I chemical under this subchapter:
The Attorney General may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.
The Attorney General is authorized to inspect the establishment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him.
1 See References in Text note below.
21 U.S.C. § 822
REFERENCES IN TEXTThis subchapter, referred to in subsecs. (b), (c), and (g)(1), was in the original "this title", meaning title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under sectionof this title and Tables.Section of this title, referred to in subsec. (c)(3), was redesignated section of this title by Pub. L. 98-473, title II, §507(a), Oct. 12, 1984, 98 Stat. 2071, and was further redesignated section of this title by Pub. L. 99-570, title I, §1003(b)(2), Oct. 27, 1986, 100 Stat. 3207-6.
AMENDMENTS2018-Subsec. (g)(5). Pub. L. 115-271 added par. (5).2014-Subsec. (e). Pub. L. 113-143 designated existing provisions as par. (1) and added par. (2).2010-Subsec. (g). Pub. L. 111-273 added subsec. (g).1993-Subsec. (a)(1). Pub. L. 103-200, §3(b)(1), inserted "or list I chemical" after "controlled substance" in two places.Subsec. (b). Pub. L. 103-200, §3(b)(2), inserted "or list I chemicals" after "controlled substances" and "or chemicals" after "such substances".Subsec. (c). Pub. L. 103-200, §3(b)(3), inserted "or list I chemical" after "controlled substance" wherever appearing.Subsec. (e). Pub. L. 103-200, §3(b)(4), inserted "or list I chemicals" after "controlled substances".1984-Subsec. (a). Pub. L. 98-473 designated existing provisions as par. (1), struck out provisions relating to dispensing controlled substances, and added par. (2).
EFFECTIVE DATE OF 1993 AMENDMENT Amendment by Pub. L. 103-200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103-200 set out as a note under sectionof this title.
EFFECTIVE DATESection effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91-513 set out as a note under sectionof this title.
RULE OF CONSTRUCTION RELATING TO STATE AND LOCAL LAW Pub. L. 115-271, title III, §3222(c), Oct. 24, 2018, 132 Stat. 3949, provided that: "Nothing in this section [amending this section and enacting provisions set out as a note below] or the amendments made by this section shall be construed to prevent a State or local government from imposing additional controls or restrictions relating to the regulation of the disposal of controlled substances in hospice care or hospice programs."
GUIDANCE Pub. L. 115-271, title III, §3222(b), Oct. 24, 2018, 132 Stat. 3949, provided that: "The Attorney General may issue guidance to hospice programs (as defined in paragraph (5) of section 302(g) of the Controlled Substances Act (), as added by subsection (a)) to assist the programs in satisfying the requirements under such paragraph (5)."
FINDINGSPub. L. 111-273, §2, Oct. 12, 2010, 124 Stat. 2858, provided that: "Congress finds the following:"(1) The nonmedical use of prescription drugs is a growing problem in the United States, particularly among teenagers."(2) According to the Department of Justice's 2009 National Prescription Drug Threat Assessment-"(A) the number of deaths and treatment admissions for controlled prescription drugs (CPDs) has increased significantly in recent years;"(B) unintentional overdose deaths involving prescription opioids, for example, increased 114 percent from 2001 to 2005, and the number of treatment admissions for prescription opioids increased 74 percent from 2002 to 2006; and"(C) violent crime and property crime associated with abuse and diversion of CPDs has increased in all regions of the United States over the past 5 years. "(3) According to the Office of National Drug Control Policy's 2008 Report 'Prescription for Danger', prescription drug abuse is especially on the rise for teens-"(A) one-third of all new abusers of prescription drugs in 2006 were 12- to 17-year-olds;"(B) teens abuse prescription drugs more than any illicit drug except marijuana-more than cocaine, heroin, and methamphetamine combined; and"(C) responsible adults are in a unique position to reduce teen access to prescription drugs because the drugs often are found in the home."(4)(A) Many State and local law enforcement agencies have established drug disposal programs (often called 'take-back' programs) to facilitate the collection and destruction of unused, unwanted, or expired medications. These programs help get outdated or unused medications off household shelves and out of the reach of children and teenagers."(B) However, take-back programs often cannot dispose of the most dangerous pharmaceutical drugs-controlled substance medications-because Federal law does not permit take-back programs to accept controlled substances unless they get specific permission from the Drug Enforcement Administration and arrange for full-time law enforcement officers to receive the controlled substances directly from the member of the public who seeks to dispose of them. "(C) Individuals seeking to reduce the amount of unwanted controlled substances in their household consequently have few disposal options beyond discarding or flushing the substances, which may not be appropriate means of disposing of the substances. Drug take-back programs are also a convenient and effective means for individuals in various communities to reduce the introduction of some potentially harmful substances into the environment, particularly into water."(D) Long-term care facilities face a distinct set of obstacles to the safe disposal of controlled substances due to the increased volume of controlled substances they handle."(5) This Act [see Short Title of 2010 Amendment note set out under sectionof this title] gives the Attorney General authority to promulgate new regulations, within the framework of the Controlled Substances Act [ et seq.], that will allow patients to deliver unused pharmaceutical controlled substances to appropriate entities for disposal in a safe and effective manner consistent with effective controls against diversion."(6) The goal of this Act is to encourage the Attorney General to set controlled substance diversion prevention parameters that will allow public and private entities to develop a variety of methods of collection and disposal of controlled substances, including some pharmaceuticals, in a secure, convenient, and responsible manner. This will also serve to reduce instances of diversion and introduction of some potentially harmful substances into the environment."
PROVISIONAL REGISTRATION Pub. L. 91-513, title II, §703, Oct. 27, 1970, 84 Stat. 1283, as amended by Pub. L. 99-514, §2, Oct. 22, 1986, 100 Stat. 2095, provided that:"(a)(1) Any person who-"(A) is engaged in manufacturing, distributing, or dispensing any controlled substance on the day before the effective date of section 302 [this section], and"(B) is registered on such day under section 510 of the Federal Food, Drug, and Cosmetic Act [sectionof this title] or under section 4722 of the Internal Revenue Code of 1986 [formerly I.R.C. 1954, section 4722 of Title 26], shall, with respect to each establishment for which such registration is in effect under any such section, be deemed to have a provisional registration under section 303 [section of this title] for the manufacture, distribution, or dispensing (as the case may be) of controlled substances."(2) During the period his provisional registration is in effect under this section, the registration number assigned such person under such section 510 [section of this title] or under such section 4722 [section 4722 of Title 26] (as the case may be) shall be his registration number for purposes of section 303 of this title [section of this title]."(b) The provisions of section 304 [section of this title], relating to suspension and revocation of registration, shall apply to a provisional registration under this section."(c) Unless sooner suspended or revoked under subsection (b), a provisional registration of a person under subsection (a)(1) of this section shall be in effect until- "(1) the date on which such person has registered with the Attorney General under section 303 [section of this title] or has had his registration denied under such section, or "(2) such date as may be prescribed by the Attorney General for registration of manufacturers, distributors, or dispensers, as the case may be,whichever occurs first."