Page:United States Statutes at Large Volume 86.djvu/602

From Wikisource
Jump to: navigation, search
This page needs to be proofread.
[86 STAT. 560]
[86 STAT. 560]
PUBLIC LAW 92-000—MMMM. DD, 1972


PUBLIC LAW 92-387-AUG. 16, 1972

52 Stat. 1040. 21 USC 301.

76 Stat. 7 8 1. 59 Stat. 4 6 3. 21 USC 355, 357. Registration, drug list requirements. 76 Stat. 794. 52 Stat. 1050; 76 Stat. 790. 21 USC 352.

55 Stat. 82 Stat. 21 USC 360b. 65 Stat. 21 USC

851. 343. 356, 648. 353.



drugs has no ready means of determining what drugs are actually being manufactured or packed by establishments registered under the Federal Food, Drug, and Cosmetic Act except by periodic inspection of such registered establishments. Knowledge of which particular drugs are being manufactured or packed by each registered establishment would substantially assist in the enforcement o i Federal laws requiring that such drugs be pure, safe, effective, and properly labeled. Information on the discontinuance of a particular drug could serve to alleviate the burden of reviewing and implementing enforcement actions against drugs which, although commercially discontinued, remain active for regulatory purposes. Information on the type and number of different drugs being manufactured or packed by drug establishments could permit more effective and timely regulation by the agencies of the Federal Government responsible for regulating drugs, including identification of which drugs in interstate commerce are subject to section 505 or 507, or to other provisions of the Federal Food, Drug, and Cosmetic Act. SEC. 3. Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended by adding at the end of the following new subsection: " (j)(1) Every person who registers with the Secretary under subsection (b), (c), or (d) shall, at the time of registration under any such subsection, file with the Secretary a list of all drugs (by established name (as defined in section 502(e)) and by any proprietary name) which are being manufactured, prepared, propagated, compounded, or processed by him for commercial distribution and which he has not included in any list of drugs filed by him with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by— " (A) in the case of a drug contained in such list and subject to section 505, 506, 507, or 512, a reference to the authority for the marketing of such drug and a copy of all labeling for such drug; " (B) in the case of any other dru^ contained in such list— " (i) which is subject to section 503(b)(1), a copy of all labeling for such drug, a representative sampling of advertisements for such drug, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product, or "(ii) which is not subject to section 503(b)(1), the label and package insert for such drug and a representative sampling of any other labeling for such drug; " (C) in the case of any drug contained in such list which is described in subpararaph (B), a quantitative listing of its active ingredient or ingredients, except that with respect to a particular drug product the Secretary may require the submission of a quantitative listing of all ingredients if he finds that such submission is necessary to carry out the purposes of this Act; and " (D) if the registrant filing the list has determined that a particular drug product contained in such list is not subject to section 7' 505, 506, 507, or 512, a brief statement of the basis upon which the registrant made such determination if the Secretary requests such a statement with respect to that particular drug product.