A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for a Federal Drug Compendium which provides reliable, complete, and readily accessible prescribing information; to assure safety and efficacy of drugs through certification of certain drugs other than insulin and antibiotics; to require certain information in drug labeling; and to improve the administration and enforcement of the Act as it relates to drugs.

Title I: Federal Drug Compendium - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health, Education, and Welfare to prepare and publish a drug compendium and distribute it to all practitioners licensed to prescribe and administer drugs.

States that the compendium shall list all drugs by established name and requires such listing to include adequate and reliable prescribing information for each drug.

Directs the Secretary to list the proprietary names of all listed drugs and the names of suppliers from whom such drugs may be obtained.

Allows the Secretary to issue a price information supplement to the compendium.

Permits the Secretary to exclude any drug of questionable safety from the compendium.

Establishes procedures to insure due process of law for any person adversely affected by a decision of the Secretary to include or exclude a drug from the compendium.

Allows the Secretary to establish an Advisory Committee on matters pertaining to the compendium.

Authorizes the Secretary to require persons engaged in manufacturing, preparing, distributing, or importing drugs to furnish any available information relating to such to the Secretary. Empowers the Secretary to require the maintenance of records of clinical experience and other such data relevant to such drugs.

Permits the Secretary to waive certain package insert requirements established by regulation.

Deems a drug misbranded if it has labeling or advertising inconsistent with the compendium description, except a drug shall not be deemed misbranded solely by reason of such inconsistency if it is in full conformity with labeling regulations.

Title II: Drug Certification - Permits the Secretary to require batch-by-batch certification of any drug intended for human use if he determines protection of the public health requires such certification.

Requires the certification of any batch of drugs meeting the requirements established by the Secretary.

Grants to the Secretary the power to exempt any drug from such certification requirements if in his judgment such certification is no longer necessary to protect the public.

Directs the Secretary to promulgate regulations exempting from such certification requirements drugs: (1) processed or packed at a place other than where manufactured, provided such drugs are subsequently certified; (2) used to manufacture other drugs; and (3) used for investigational purposes only.

Requires every person manufacturing, compounding, or processing any drug to keep such records and make such reports as the Secretary may require.

Permits the Secretary to ban any drug he has found, after holding a hearing, presents an unreasonable risk of illness, injury, or deception and the public cannot be adequately protected by regulation.

Title III: Drug Labeling - Requires any drug whose effectiveness or potency diminishes over time to bear a label specifying the date beyond which such drug should not be used.

Requires any prescription drug intended for human use and determined to be potentially dangerous when taken as directed to carry a clear warning of such fact on its label.

Imposes specific labeling requirements on any drug containing only one active ingredient.

Requires the Secretary to designate an official name for any new drug and permits the Secretary to designate an official name for any other drug.

Title IV: Administration and Enforcement - Redefines the term "new drug" to delete the exception granted to drugs subject to the Food and Drug Act of 1906.

Subjects all new drugs intended for human or animal use to the full requirements of the Federal Food, Drug, and Cosmetic Act.

States that misleading advertising or promotional material shall be considered in determining whether an article is misbranded.

Deems advertising, labeling, or promotional material misleading if the representations made or suggested by such material bear upon: (1) the safety or effectiveness of a drug and such representations cannot be supported by scientific investigation; or (2) any aspect of a drug and such representations cannot be supported by appropriate data.

Exempts specified members of the communication media from the penalties imposed for the dissemination of any false or misleading advertisement or promotional material unless such member refuses a request of the Secretary to furnish the name and address of the party causing such member to disseminate such false advertising on promotional material.

Exempts an advertising agency from the penalties imposed for having caused the dissemination of any false advertisement or promotional material unless such agency has refused a request of the Secretary for the name and address of such party causing such agency to disseminate such false advertisement or promotional material.

Excludes from the operation of any restraining order or injunction directed against such false advertising or promotional material any issue of a regularly published publication whenever it appears: (1) the regular delivery of such issue would be delayed; and (2) such delay is due to the method of publication and is not a device to avoid such injunction or restraining order.

Declares a food or cosmetic misbranded if the advertising or promotional material for such food or cosmetic is misleading.

Permits the Secretary to withdraw approval for a new drug if the advertising or promotional material for such drug: (1) suggests such drug will have an effect that is unsupported by evidence; and (2) is false or misleading and was not corrected after notice.

Grants to the Secretary certain powers contained in the Federal Trade Commission Act.

Includes within the coverage of the inspection and subpena powers of the Secretary: (1) consulting laboratories; and (2) the financial, sales, pricing, and personnel data of any party subject to this Act to the extent that such data relates to representations made in advertising or promotional material. Specifies the term "inspection" shall include the taking of photographs and the copying of documentary materials.

Authorizes the Secretary to require by subpena the attendance of witnesses and the production of evidence.

Grants use immunity to any person compelled to attend a hearing or produce documentary evidence.