PRIA, Government Policy, Made Personal

Summary

Labels on commercial containers of controlled drugs must show an identifying symbol set by the Attorney General’s rules. Each drug schedule needs a different symbol. Manufacturers may not distribute a controlled drug without that symbol. When drugs in schedule II, III, or IV are given to a patient, the label must have a clear, short warning that it is a crime to give the drug to anyone else. Drugs in schedule I or II, and narcotic drugs in schedule III or IV, must be shipped in containers that are securely sealed as the Attorney General requires. Anabolic steroids and products that contain them must be labeled with the steroid’s chemical name using IUPAC nomenclature. A product does not need the IUPAC name if it is labeled under the Federal Food, Drug, and Cosmetic Act because it has an approved application under FDA section 505(b) or 505(j), or if it is only for investigational use under 505(i) and is used only in a clinical trial covered by an effective IND.

Title 21, §825

Food and Drugs, Source: USLM XML via OLRC

(a)Symbol

It shall be unlawful to distribute a controlled substance in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label (as defined in section 321(k) of this title) containing an identifying symbol for such substance in accordance with such regulations. A different symbol shall be required for each schedule of controlled substances.

(b)Unlawful distribution without identifying symbol

It shall be unlawful for the manufacturer of any controlled substance to distribute such substance unless the labeling (as defined in section 321(m) of this title) of such substance contains, when and as required by regulations of the Attorney General, the identifying symbol required under subsection (a).

(c)Warning on label

The Secretary shall prescribe regulations under section 353(b) of this title which shall provide that the label of a drug listed in schedule II, III, or IV shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient.

(d)Containers to be securely sealed

It shall be unlawful to distribute controlled substances in schedule I or II, and narcotic drugs in schedule III or IV, unless the bottle or other container, stopper, covering, or wrapper thereof is securely sealed as required by regulations of the Attorney General.

(e)False labeling of anabolic steroids

(1)It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, an anabolic steroid or product containing an anabolic steroid, unless the steroid or product bears a label clearly identifying an anabolic steroid or product containing an anabolic steroid by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC).

(2)(A)A product described in subparagraph (B) is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(B)A product is described in this subparagraph if the product—

(i)is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b), (j)]; or

(ii)is exempt from the provisions of section 505 of such Act relating to new drugs because—

(I)it is intended solely for investigational use as described in section 505(i) of such Act; and

(II)such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.

Notes & Related Subsidiaries

Editorial Notes

References in Text

Schedules I, II, III, and IV, referred to in subsecs. (c) and (d), are set out in section 812(c) of this title. The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (e)(2)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, 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.

Amendments

2014—Subsec. (e). Pub. L. 113–260 added subsec. (e).

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, but with Attorney General authorized to postpone such

Effective Date

for such period as he might determine to be necessary for the efficient administration of this subchapter, see section 704(c) of Pub. L. 91–513, set out as a note under section 801 of this title. Identification and Publication of List of Products Containing Anabolic Steroids Pub. L. 113–260, § 4, Dec. 18, 2014, 128 Stat. 2932, provided that: “(a) In General.—The Attorney General may, in the Attorney General’s discretion, collect data and analyze products to determine whether they contain anabolic steroids and are properly labeled in accordance with this Act [see section 1 of Pub. L. 113–260, set out as a

Short Title

of 2014 Amendment note under section 801 of this title] and the

Amendments

made by this Act. The Attorney General may publish in the Federal Register or on the website of the Drug

Enforcement

Administration a list of products which the Attorney General has determined, based on substantial evidence, contain an anabolic steroid and are not labeled in accordance with this Act and the

Amendments

made by this Act. “(b) Absence From List.—The absence of a product from the list referred to in subsection (a) shall not constitute evidence that the product does not contain an anabolic steroid.”

§825 Labeling and Packaging

Summary

Title 21, §825

Notes & Related Subsidiaries

Editorial Notes

References in Text

Amendments

Statutory Notes and Related Subsidiaries

Effective Date

Effective Date

Short Title

Amendments

Enforcement

Amendments

Citations & Metadata