21 U.S. Code § 823 - Registration requirements
Registration granted under subsections (a) and (b) of this section shall not entitle a registrant to (1) manufacture or distribute controlled substances in schedule I or II other than those specified in the registration, or (2) manufacture any quantity of those controlled substances in excess of the quota assigned pursuant to section 826 of this title.
In this section, the phrase “factors as may be relevant to and consistent with the public health and safety” means factors that are relevant to and consistent with the findings contained in section 801 of this title.
 So in original. Probably should be “combinations of drugs.”.
Schedules I, II, III, IV, and V, referred to in subsecs. (a) to (f) and (g)(2), are set out in section 812(c) of this title.
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (g)(2)(C)(i), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.
This chapter, referred to in subsec. (g)(2)(J)(ii)(II), was in the original “this Act”, meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, as amended. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.
2016—Subsec. (j). Pub. L. 114–145 added subsec. (j).
2015—Subsec. (i). Pub. L. 114–89 added subsec. (i).
2008—Subsec. (f). Pub. L. 110–425, in introductory provisions, inserted “and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet” after “schedule II, III, IV, or V” and substituted “or such modification of registration if the Attorney General determines that the issuance of such registration or modification” for “if he determines that the issuance of such registration”.
2006—Subsec. (g)(2)(B)(iii). Pub. L. 109–469, § 1102(1), substituted “unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The” for “except that the”.
Subsec. (g)(2)(J)(i). Pub. L. 109–469, § 1102(2)(A), substituted “thereafter.” for “thereafter except as provided in clause (iii) (relating to a decision by the Secretary or the Attorney General that this paragraph should not remain in effect).”
Subsec. (g)(2)(J)(ii). Pub. L. 109–469, § 1102(2)(B), substituted “December 29, 2006” for “October 17, 2000” in introductory provisions.
Subsec. (g)(2)(J)(iii). Pub. L. 109–469, § 1102(2)(C), substituted “subparagraph (B)(iii) should be applied by limiting the total number of patients a practitioner may treat to 30, then the provisions in such subparagraph (B)(iii) permitting more than 30 patients shall not apply, effective” for “this paragraph should not remain in effect, this paragraph ceases to be in effect”.
2005—Subsec. (g)(2)(B)(iii). Pub. L. 109–56, § 1(b), substituted “The total” for “In any case in which the practitioner is not in a group practice, the total”.
Subsec. (g)(2)(B)(iv). Pub. L. 109–56, § 1(a), struck out cl. (iv) which read as follows: “In any case in which the practitioner is in a group practice, the total number of such patients of the group practice at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, except that the Secretary may by regulation change such total number, and the Secretary for such purposes may by regulation establish different categories on the basis of the number of practitioners in a group practice and establish for the various categories different numerical limitations on the number of such patients that the group practice may have.”
2002—Subsec. (g)(2)(I). Pub. L. 107–273, § 2501(1), which directed the substitution of “on the date of approval by the Food and Drug Administration of a drug in schedule III, IV, or V, a State may not preclude a practitioner from dispensing or prescribing such drug, or combination of such drugs,” for “on October 17, 2000, a State may not preclude a practitioner from dispensing or prescribing drugs in schedule III, IV, or V, or combinations of such drugs,”, was executed by making the substitution for the phrase which in the original began with “on the date of the enactment of the Drug Addiction Treatment Act of 2000,” rather than the editorial translation “on October 17, 2000,” to reflect the probable intent of Congress.
Subsec. (g)(2)(J)(i). Pub. L. 107–273, § 2501(2), which directed the substitution of “the date referred to in subparagraph (I),” for “October 17, 2000,” was executed by making the substitution for text which in the original read “the date of the enactment of the Drug Addiction Treatment Act of 2000,” rather than the editorial translation “October 17, 2000,” to reflect the probable intent of Congress.
2000—Subsec. (g). Pub. L. 106–310 designated existing provisions as par. (1), substituted “Except as provided in paragraph (2), practitioners who dispense” for “Practitioners who dispense”, redesignated former pars. (1) to (3) as subpars. (A) to (C), respectively, of par. (1) and redesignated former subpars. (A) and (B) of former par. (2) as cls. (i) and (ii), respectively, of subpar. (B) of par. (1), and added par. (2).
1993—Subsec. (h). Pub. L. 103–200 added subsec. (h).
1984—Subsec. (f). Pub. L. 98–473 amended subsec. (f) generally, substituting provisions relating to registration authority of Attorney General respecting dispensation or conduct of research with controlled research, and separate authority of Secretary respecting registration, for provisions relating to general registration requirements respecting dispensation or conduct of research with controlled or nonnarcotic controlled substances.
1978—Subsec. (f). Pub. L. 95–633 inserted provision relating to the construction of the Convention on Psychotropic Substances.
1974—Subsec. (g). Pub. L. 93–281 added subsec. (g).
Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.
For provisional registration of persons engaged in manufacturing, distributing, or dispensing of controlled substances on the day before the effective date of section 822 of this title who are registered on such date under section 360 of this title or section 4722 of Title 26, Internal Revenue Code, see section 703 of Pub. L. 91–513, set out as a note under section 822 of this title.
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