XIX. THE DRUG LISTING ACT OF 1972

As of 1972, the Food and Drug Administration had no ready means of determining what drugs were actually being manufactured and commercially distributed by establishments registered under the Food, Drug, and Cosmetic Act except by periodic inspection of the establishments.

In an effort to increase the FDA's regulatory tools in this area, legislation was introduced in the 92nd Congress to provide for a current listing of each drug manufactured, prepared, propagated, compounded, or processed by a registrant under the Act. During the hearings on the proposed legislation, the Commissioner of the FDA stated that availability of a current inventory of drugs would substantially assist in the enforcement of Federal laws requiring that drugs be pure, safe, effective, and properly labeled. The legislation under consideration was passed and signed into public law on August 16, 1972.33

The Drug Listing Act required manufacturers and processors of drugs to submit to the Secretary a list of all drugs manufactured or processed for commercial distribution. Any drug contained in the list which is subject to the requirements of the Act for new drugs, insulin, antibiotics, or animal drugs must be accompanied by a reference to the authority for marketing and a copy of all labeling for the drug. Those prescription drugs not subject to these specific requirements must be accompanied by a copy of the current labeling, and a representative sampling of advertisements for the product. Over-the-counter drugs not subject to requirements for new drugs, insulin, antibiotics, or animal drugs must be accompanied by the label and package insert and a representative sampling of any other labeling for the drug. In the case of those drugs (prescription or over-the-counter) not subject to the special requirements of the Act, a quantitative listing of all active ingredients is to be submitted. The submission of a quantitative listing of all ingredients (including inactive ingredients) of a particular drug may be required if deemed necessary to carry out the purposes of the Act. The manufacturer or processor may also be required to state why he has determined a particular product is not subject to the requirements for new drugs, insulin, antibiotics or new animal drugs.

Supplemental filings are required every six months if there has been a material change in any information previously submitted, if a drug is introduced for commercial distribution after the previous filing, if a drug has been discontinued, or if a previously discontinued drug is reintroduced.

The Act also contains a number of other provisions designed to increase the efficiency of the FDA in regulating drugs.

33 86 Stat. 559, 92nd Cong., 2d sess.; Aug. 16, 1972.

CAPSULE LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

I. The Food and Drug Act of 1906 (S. 88)

P.L. 59-384; June 30, 1906.

Senate Report No. 59-8 (Comm. on Manufacturers).

House Report No. 59-2118 (Comm. on Interstate and Foreign Commerce).

Conference Report No. 59-5056.

Feb. 21: considered and passed Senate.

June 23: considered and passed House, amended.
June 29: Senate agreed to conference report.
June 29: House agreed to conference report.

II. The Sherley Amendment of 1912 (H.R. 11877)
P.L. 62-301; Aug. 23, 1912.

House Report No. 62-1138.

Aug 19: considered and passed House.
Aug. 20: considered and passed Senate.

III. The Federal Food, Drug, and Cosmetic Act of 1938 (S. 5)

P.L. 75-717; June 25, 1938.

Senate Report No. 75-91 (Comm. on Commerce).

Senate Report No. 75-152 (amended report).

House Report No. 75-2139; supplemental report, pt. II (Comm. on Interstate and Foreign Commerce).

Conference Report No. 75-2716.

Mar. 9: considered and passed Senate.

June 1: considered and passed House, amended.
June 10: Senate agreed to conference report.
June 13: House agreed to conference report.

IV. Insulin and Antibiotic Certification Amendments

P.L. 77-366; Dec. 22, 1941 (H.R. 6251).

House Report No. 77-1542 (Comm. on Interstate and Foreign Commerce).

Dec. 18: considered and passed House.

Dec. 19: considered and passed Senate. P.L. 79-139; July 6, 1945 (H.R. 3266).

House Report No. 79-702 (Comm. on Interstate and Foreign Com

merce).

Senate Report No. 79-410 (Comm. on Commerce).

June 19: considered and passed House.

July 2: considered and passed Senate.

P.L. 80-16; Mar. 10, 1947 (H.R. 2045).

(334)

House Report No. 80-75 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 80-45 (S. 445) (Comm. on Interstate and Foreign Commerce).

Mar. 3: considered and passed House.

Mar. 5: considered and passed Senate, in lieu of S. 445.

P.L. 81-164; July 13, 1949 (H.R. 3151).

House Report No. 81-499 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 81-600 (Comm. on Labor and Public Welfare). May 16: considered and passed House.

July 6: considered and passed Senate.

P.L. 87-781; Oct. 10, 1962 (S. 1552).

Senate Report No. 87-1744 (Comm. on the Judiciary).

House Report No. 87-2464 (H.R. 11581); supplemental report, pt. II (Comm. on Interstate and Foreign Commerce).

Conference Report No. 87-2526.

Aug. 23: considered and passed Senate.

Sept. 27: considered and passed House, amended, in lieu of
H.R. 11581.

Oct. 3: Senate agreed to conference report.
Oct. 4: House agreed to conference report.

V. Regulatory Amendments of 1948 (H.R. 4071)
P.L. 80-749; June 24, 1948.

House Report No. 80-807 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 80-1221 (Comm. on Interstate and Foreign Commerce).

Conference Report No. 80-2400.

Jan. 13: considered and passed House.

June 15: considered and passed Senate, amended.

June 17: Senate agreed to conference report.

June 18: House agreed to conference report.

VII. The Durham-Humphrey Amendment of 1951 (H.R. 3298)
P.L. 82-215; Oct. 26, 1951.

House Report No. 82-700 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 82-946 (Comm. on Labor and Public Welfare). Aug. 1: considered and passed House.

Oct. 15: considered and passed Senate, amended.

Oct. 17: House agreed to Senate amendments.

VIII. Factory Inspection Amendments of 1953 (H.R. 5740)

P.L. 83-217; Aug. 7, 1953.

House Report No. 83-708 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 83-712 (Comm. on Labor and Public Welfare).
July 16: considered and passed House.

Aug. 3: considered and passed Senate, amended.
Aug. 3: House disagreed with Senate amendment.
Aug. 3: Senate receded from amendment.

IX. Food Standard Amendments of 1954 (H.R. 6434)

P.L. 83-335; Apr. 15, 1954.

House Report No. 83-934 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 83-1060 (Comm. on Labor and Public Welfare). July 30: considered and passed House.

Apr. 5: considered and passed Senate.

X. The Pesticide Chemical Amendment of 1954 (H.R. 7125)

P.L. 83-518; July 22, 1954.

House Report No. 83-1385 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 83-1635 (Comm. on Labor and Public Welfare). Apr. 5: considered and passed House.

July 6: considered and passed Senate, amended.

July 8: House agreed to Senate amendments.

XI. Orange Coloring Amendment of 1956 (H.R. 7732)

P.L. 84-672; July 9, 1956.

House Report No. 84-1982 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 84-2391 (Comm. on Labor and Public Welfare). Apr. 6: considered and passed House.

July 2: considered and passed Senate.

XII. Food Standard Amendments of 1956 (H.R. 9547)

P.L. 84-905; Aug. 1, 1956.

House Report No. 84-2623 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 84-2752 (Comm. on Labor and Public Welfare). July 16: considered and passed House.

July 23: considered and passed Senate.

XIII. The Food Additives Amendments of 1958 (H.R. 13254)

P.L. 85-929; Sept. 6, 1958.

House Report No. 85-2284 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 85-2422 (Comm. on Labor and Public Welfare). Aug. 13: considered and passed House.

Aug. 23: considered and passed Senate, amended.

Aug. 23: House House agreed to Senate amendments.

XIV. Orange Coloring (S. 79)

P.L. 86-2; Mar. 17, 1959.

Senate Report No. 86-50 (Comm. on Labor and Public Welfare). House Report No. 86-44 (Comm. on Interstate and Foreign Commerce).

House Report No. 86-88 (rereported).

Feb. 9: considered and passed Senate.
Mar. 13: considered and passed House.

XV. Insecticide Amendments of 1959 (H.R. 6436)

P.L. 86-139; Aug. 7, 1959.

House Report No. 86-552 (Comm. on Agriculture).

Senate Report No. 86-519 (Comm. on Agriculture and Forestry). July 6: considered and passed House.

July 16: considered and passed Senate.

July 29: House agreed to Senate amendments.

XVI. Color Additive Amendments of 1960 (S. 2197)

P.L. 86-618; July 12, 1960.

Senate Report No. 86-795 (Comm. on Labor and Public Welfare). House Report No. 86–1761 (H.R. 7624) (Comm. on Interstate and Foreign Commerce).

Aug. 24: considered and passed Senate.

June 25: considered and passed House, amended, in lieu of H.R. 7624.

June 30: Senate agreed to House amendments.

XVII. The Drug Amendments of 1962 (S. 1552)

P.L. 87-781: Oct. 10, 1962.

Senate Report No. 87-1744 (Comm. on the Judiciary).

House Report No. 87-2464 (H.R. 11581); supplemental report, pt. II (Comm. on Interstate and Foreign Commerce).

Conference Report No. 87-2526.

Aug. 23: considered and passed Senate.

Sept. 27: considered and passed House, amended, in lieu of H.R. 11581.

Oct. 3: Senate agreed to conference report.

Oct. 4: House agreed to conference report.

XVIII. Animal Drug Amendments of 1968 (H.R. 3639)

P.L. 90-399; July 13, 1968.

House Report No. 90-875 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 90-1308 (Comm. on Labor and Public Welfare).
Nov. 6: considered and passed House.

June 24: considered and passed Senate, amended.
July 2: House agreed to Senate amendments.

XIX. The Drug Listing Act of 1972 (H.R. 9936)

P.L. 92-387; Aug. 16, 1972.

House Report No. 92-437 (Comm. on Interstate and Foreign Commerce).

Senate Report No. 92-924 (Comm. on Labor and Public Welfare).
Sept. 16: considered and passed House.

June 30: considered and passed Senate, amended.
Aug. 1: House agreed to Senate amendments.