Browse Bills

There is one summary for this bill. Bill summaries are authored by CRS.

Federal Drug Compendium Act - Requires the Secretary of Health, Education, and Welfare to prepare and publish in a readable and practicable form and under a distinct and suitable name a drug compendium and to distribute such compendium on a current basis to all practitioners licensed by law to prescribe and administer drugs listed therein. Provides that such compendium shall list all drugs that are lawfully available in the United States and shall provide for such drugs adequate and reliable prescribing information required for their safe and effective use. States that the Secretary shall also include in such compendium the proprietary names or designations under which a drug listed in the compendium by established name is available and the names of suppliers from whom such drugs may be obtained.

Authorizes the Secretary to omit drugs from the compendium if he determines that there is substantial doubt as to the safety of such drugs or compliance with this or other Federal law. Sets forth a procedure for petitioning for changes in the compendium or for preventing the delisting of drugs.

Establishes an advisory committee for the purpose of advising the Secretary from time to time on matters pertaining to the compendium.

Authorizes the Secretary to require, by order, any person engaged in manufacturing, preparing, compounding, processing, propagating, producing, distributing or importing any drug to furnish to the Secretary any information available to such person and relevant to any matter bearing on which drugs or information relating thereto should be included in the compendium. Provides that in case of refusal or failure to obey such an order, any district court for the judicial district in which the person is found or resides or transacts business shall, upon application by the Secretary, have jurisdiction to issue an order requiring such person to comply with the Secretary's order.

Provides that the Secretary shall prescribe fees to be paid to him by persons engaged in the manufacture, preparation, propagation, compounding, processing, or distribution of drugs intended for humans, as he determines to be necessary to defray the cost of the compendium. States that such fees shall be based upon the volume of the drug business done by such persons and such other factors as the Secretary may determine to be relevant.

Creates a drug compendium revolving fund which shall be available to the Secretary, without fiscal year limitation, as a revolving fund for the purpose of preparing and keeping current, publishing, and distributing the drug compendium provided for in this Act. Provides that all expenses incurred by the Secretary in carrying out this title, including refunds of overpayments for fees prescribed pursuant to this title and including due by reason of remission or mitigation of penalties, shall be paid from the fund.

Provides for the waiver of the drug package insert requirement for a drug if such drug is intended and promoted solely for the conditions of use described in the compendium.

There is one summary for this bill. Bill summaries are authored by CRS.

Federal Drug Compendium Act - Requires the Secretary of Health, Education, and Welfare to prepare and publish in a readable and practicable form and under a distinct and suitable name a drug compendium and to distribute such compendium on a current basis to all practitioners licensed by law to prescribe and administer drugs listed therein. Provides that such compendium shall list all drugs that are lawfully available in the United States and shall provide for such drugs adequate and reliable prescribing information required for their safe and effective use. States that the Secretary shall also include in such compendium the proprietary names or designations under which a drug listed in the compendium by established name is available and the names of suppliers from whom such drugs may be obtained.

Authorizes the Secretary to omit drugs from the compendium if he determines that there is substantial doubt as to the safety of such drugs or compliance with this or other Federal law. Sets forth a procedure for petitioning for changes in the compendium or for preventing the delisting of drugs.

Establishes an advisory committee for the purpose of advising the Secretary from time to time on matters pertaining to the compendium.

Authorizes the Secretary to require, by order, any person engaged in manufacturing, preparing, compounding, processing, propagating, producing, distributing or importing any drug to furnish to the Secretary any information available to such person and relevant to any matter bearing on which drugs or information relating thereto should be included in the compendium. Provides that in case of refusal or failure to obey such an order, any district court for the judicial district in which the person is found or resides or transacts business shall, upon application by the Secretary, have jurisdiction to issue an order requiring such person to comply with the Secretary's order.

Provides that the Secretary shall prescribe fees to be paid to him by persons engaged in the manufacture, preparation, propagation, compounding, processing, or distribution of drugs intended for humans, as he determines to be necessary to defray the cost of the compendium. States that such fees shall be based upon the volume of the drug business done by such persons and such other factors as the Secretary may determine to be relevant.

Creates a drug compendium revolving fund which shall be available to the Secretary, without fiscal year limitation, as a revolving fund for the purpose of preparing and keeping current, publishing, and distributing the drug compendium provided for in this Act. Provides that all expenses incurred by the Secretary in carrying out this title, including refunds of overpayments for fees prescribed pursuant to this title and including due by reason of remission or mitigation of penalties, shall be paid from the fund.

Provides for the waiver of the drug package insert requirement for a drug if such drug is intended and promoted solely for the conditions of use described in the compendium.

There is one summary for this bill. Bill summaries are authored by CRS.

Federal Drug Compendium Act - Requires the Secretary of Health, Education, and Welfare to prepare and publish in a readable and practicable form and under a distinct and suitable name a drug compendium and to distribute such compendium on a current basis to all practitioners licensed by law to prescribe and administer drugs listed therein. Provides that such compendium shall list all drugs that are lawfully available in the United States and shall provide for such drugs adequate and reliable prescribing information required for their safe and effective use. States that the Secretary shall also include in such compendium the proprietary names or designations under which a drug listed in the compendium by established name is available and the names of suppliers from whom such drugs may be obtained.

Authorizes the Secretary to omit drugs from the compendium if he determines that there is substantial doubt as to the safety of such drugs or compliance with this or other Federal law. Sets forth a procedure for petitioning for changes in the compendium or for preventing the delisting of drugs.

Establishes an advisory committee for the purpose of advising the Secretary from time to time on matters pertaining to the compendium.

Authorizes the Secretary to require, by order, any person engaged in manufacturing, preparing, compounding, processing, propagating, producing, distributing or importing any drug to furnish to the Secretary any information available to such person and relevant to any matter bearing on which drugs or information relating thereto should be included in the compendium. Provides that in case of refusal or failure to obey such an order, any district court for the judicial district in which the person is found or resides or transacts business shall, upon application by the Secretary, have jurisdiction to issue an order requiring such person to comply with the Secretary's order.

Provides that the Secretary shall prescribe fees to be paid to him by persons engaged in the manufacture, preparation, propagation, compounding, processing, or distribution of drugs intended for humans, as he determines to be necessary to defray the cost of the compendium. States that such fees shall be based upon the volume of the drug business done by such persons and such other factors as the Secretary may determine to be relevant.

Creates a drug compendium revolving fund which shall be available to the Secretary, without fiscal year limitation, as a revolving fund for the purpose of preparing and keeping current, publishing, and distributing the drug compendium provided for in this Act. Provides that all expenses incurred by the Secretary in carrying out this title, including refunds of overpayments for fees prescribed pursuant to this title and including due by reason of remission or mitigation of penalties, shall be paid from the fund.

Provides for the waiver of the drug package insert requirement for a drug if such drug is intended and promoted solely for the conditions of use described in the compendium.

There is one summary for this bill. Bill summaries are authored by CRS.

Federal Drug Compendium Act - Requires the Secretary of Health, Education, and Welfare to prepare and publish in a readable and practicable form and under a distinct and suitable name a drug compendium and to distribute such compendium on a current basis to all practitioners licensed by law to prescribe and administer drugs listed therein. Provides that such compendium shall list all drugs that are lawfully available in the United States and shall provide for such drugs adequate and reliable prescribing information required for their safe and effective use. States that the Secretary shall also include in such compendium the proprietary names or designations under which a drug listed in the compendium by established name is available and the names of suppliers from whom such drugs may be obtained.

Authorizes the Secretary to omit drugs from the compendium if he determines that there is substantial doubt as to the safety of such drugs or compliance with this or other Federal law. Sets forth a procedure for petitioning for changes in the compendium or for preventing the delisting of drugs.

Establishes an advisory committee for the purpose of advising the Secretary from time to time on matters pertaining to the compendium.

Authorizes the Secretary to require, by order, any person engaged in manufacturing, preparing, compounding, processing, propagating, producing, distributing or importing any drug to furnish to the Secretary any information available to such person and relevant to any matter bearing on which drugs or information relating thereto should be included in the compendium. Provides that in case of refusal or failure to obey such an order, any district court for the judicial district in which the person is found or resides or transacts business shall, upon application by the Secretary, have jurisdiction to issue an order requiring such person to comply with the Secretary's order.

Provides that the Secretary shall prescribe fees to be paid to him by persons engaged in the manufacture, preparation, propagation, compounding, processing, or distribution of drugs intended for humans, as he determines to be necessary to defray the cost of the compendium. States that such fees shall be based upon the volume of the drug business done by such persons and such other factors as the Secretary may determine to be relevant.

Creates a drug compendium revolving fund which shall be available to the Secretary, without fiscal year limitation, as a revolving fund for the purpose of preparing and keeping current, publishing, and distributing the drug compendium provided for in this Act. Provides that all expenses incurred by the Secretary in carrying out this title, including refunds of overpayments for fees prescribed pursuant to this title and including due by reason of remission or mitigation of penalties, shall be paid from the fund.

Provides for the waiver of the drug package insert requirement for a drug if such drug is intended and promoted solely for the conditions of use described in the compendium.