Federal Drug and Devices Act

Summary

Title I: Short Title - Federal Drug and Devices Act. Title II: Definitions - Defines the terms used in this Act. Title III: Prohibited Acts and Penalties - Sets forth acts prohibited by this Act including: the adulteration or misbranding of any drug or device in interstate commerce; false guaranties, misrepresentation, or any act which renders a drug counterfeit as defined in this Act. States that the district courts of the United States shall have jurisdiction to restrain violations of this title. Provides that any person who violates a provision of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both and shall be subject to a fine of $10,000 or three years imprisonment or both for a second offense. Provides for the seizure of drugs and devices introduced into commerce in violation of the provisions of this Act. Establishes a civil penalty of $10,000 for each violation of this title. Title IV: Drugs and Devices - Sets forth the definition of an adulterated drug or device and a misbranded drug or device. Specifies substances which shall require a prescription. Directs that no person shall introduce into commerce any new drug, unless an application for approval is effective with respect to such drug. Sets forth investigative procedures which each new drug must be subjected to before approval is given. Authorizes the Commissioner of the Drug and Devices Administration to withdraw approval of an application with respect to any drug after notice and an opportunity to the applicant for a hearing. Specifies the conditions upon which the Commissioner may withdraw approval. Sets forth procedures to be followed by the Commissioner in the issuance of orders. Provides for an appeal by the applicant of an order of the Commissioner refusing or withdrawimg approval of an application. Directs the Commissioner to promulgate regulations exempting from the operation of this Act drugs intended solely for investigational use by qualified experts. Requires that in the case of any drug for which an approval of an application filed pursuant to this section is in effect, the applicant shall establish and maintain such records, conduct such post-market or post-approval studies as required by the Commissioner, and report to the Commissioner on data relating to clinical experience and information obtained by the applicant. Requires that such records be made available upon request of an officer or employee designated by the Commissioner. Provides that drugs in the final stage of investigation before either being approved or rejected by the Commissioner may be marketed subject to any conditions he may deem necessary. Directs the Commissioner to require that such drugs have approved labels. Requires that patients be warned that such drugs have not received final approval. States that the Commissioner shall design a system of registration numbers for such drugs which show the specialty and the nature of the practice of the physician prescribing such drugs. Directs that drugs not given final approval shall require an informed consent from patients receiving such drugs. Authorizes the Commissioner to designate an official name for any drug or device. Directs that such name shall be the only official name of that drug or device used in any official compendium published after such name has been prescribed. Provides that the Commissioner may review such names and make changes as he finds necessary. Requires that producers of drugs and devices register with the Commissioner. Authorizes the Commissioner to assign a registration number to producers registered in accordance with this Act. Makes the information filed with the Commission available to the public. Title V: New Animal Drugs - Establishes minimum safety standards for new animal drugs and feed containing such drugs. Requires persons to apply to the Commissioner for any intended use of such feed or drugs. Sets forth the information required to be given by each applicant. Directs the Commissioner to either approve the application or give the applicant notice of an opportunity for a hearing within a specified time. Allows the Commissioner to withdraw his approval of any such drug or feed upon a finding that the drug is unsafe. Requires applicants receiving approval of new animal drugs or feed containing such drugs to maintain records and make reports to the Commissioner of data relating to experience and other information about the drug obtained by the applicant. Title VI: Medical Devices - Directs the Commissioner to appoint classification panels of experts to review and classify devices intended for human use and to make recommendations to the Commissioner concerning the effectiveness and safety of such devices. Authorizes the Commissioner to promulgate for any device a performance standard relating to safety and effectiveness. Directs the Commissioner to consult with, and give appropriate weight to relevant standards published by other Federal agencies concerned with setting standards. Sets forth procedures for the promulgation of performance standards. Requires that persons interested in developing performance standards be invited to make offers to develop such standards as outlined by the Commissioner. Allows the Commissioner to use existing performance standards. Requires the Commissioner to review and evaluate on a continuing basis testing and other quality control programs carried out by the manufacturers of devices subject to performance standards. Authorizes the banning of devices which the Commissioner finds present an unreasonable risk of harm to the public. Requires producers to notify the Commissioner immediately of any defect in their devices. Authorizes the Commissioner to require the producer to provide adequate notification of the defect. Provides that the Commissioner may also require that the device be brought into conformity with the performance standards or repaired. Requires all producers of devices for human use to keep records and report to the Commissioner information relating to clinical experience and any other information obtained by such person with respect to such device. Authorizes the Commissioner to research the safety, development, improvement and proper use of such devices. Provides that standards promulgated by the Commissioner shall pre-empt the States' authority to establish or continue in effect any performance standard unless such requirements are identical to Federal requirements. Title VII: General Administrative Provisions - Gives the Commissioner authority to promulgate regulations for the enforcement of this Act. Sets forth the administrative procedures which shall be followed in issuing or amending any such regulation. Authorizes the Commissioner to conduct examinations and investigations for the purposes of this Act through the Drug and Devices Administration. Gives officers of the Administration access to all records of carriers and persons receiving drugs or devices. Provides that officers designated by the Assistant Commissioner of Compliance and Monitoring shall have authority to enter factories and warehouses in which drugs or devices are manufactured or held for the purpose of inspecting all things therein. Sets forth minimum safety standards for color additives. Directs the Commissioner to provide for the separate listing of color additives for use in or on drugs. Lists those factors which shall be considered by the Commissioner in determining the safety of a color additive. Provides for the certification of color additives. Sets forth procedures for the issuance, amendment or repeal of regulations dealing with color additives. Title VIII: Drug and Devices Administration - Establishes within the Department of Health, Education and Welfare, the Drug and Devices Administration which shall be headed by the Commissioner of Drugs and Devices. Provides also for the establishment of the Drug and Devices Research and Development Review Bureau, the Research and Development Bureau, and the Compliance and Monitoring Bureau. Gives the Commissioner the authority necessary to carry out this Act. Title IX: National Drug Review Board - Authorizes the establishment of a non- profit corporation to be known as the National Drug Review Board. Provides that the Board shall advise the Commissioner as necessary to carry out the purpose of this Act. Requires the Board to submit an annual report to Congress containing an analysis of drugs currently in use, the uses of such drugs, adverse and unanticipated reactions from such drugs and recommendations for legislation. Title X: Imports and Exports - Authorizes the Secretary of the Treasury to destroy or to cause to be exported any imported drug or device which the Commissioner determines to be unsafe. Sets forth standards for drugs and devices intended for export. Title XI: Miscellaneous - Transfers from the Secretary of Health, Education, and Welfare to the Commissioner specified powers necessary to carry out the provisions of this Act.

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• Introduced in Senate

  summary · EN · 20 November 1975

  Open at official source

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