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H.R.6638 - Supporting Access to Formulated and Effective Compounded Drugs Act of 2012

To amend chapter V of the Federal Food, Drug, and Cosmetic Act to enhance the requirements for pharmacies that compound drug products. view all titles (3)

All Bill Titles

  • Short: Supporting Access to Formulated and Effective Compounded Drugs Act of 2012 as introduced.
  • Official: To amend chapter V of the Federal Food, Drug, and Cosmetic Act to enhance the requirements for pharmacies that compound drug products. as introduced.
  • Short: S.A.F.E. Compounded Drugs Act of 2012 as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
12/05/12
 
 
 
 
 
 
 

Official Summary

Supporting Access to Formulated and Effective Compounded Drugs Act of 2012 or S.A.F.E. Compounded Drugs Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounded drugs. Eliminates authority for compounding pharmacies to compound any d

Official Summary

Supporting Access to Formulated and Effective Compounded Drugs Act of 2012 or S.A.F.E. Compounded Drugs Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounded drugs. Eliminates authority for compounding pharmacies to compound any drug product that is a copy of a commercially available drug. Establishes notification requirements before a patient is prescribed, dispensed, or administered a compounded drug, which must include providing the patient a document concerning the availability, safety, and production of such drugs. Requires a drug product compounded under the FFDCA to be clearly labeled as a “non-FDA approved compounded drug product.” Authorizes the Secretary of Health and Human Services (HHS) to establish different labeling requirements for compounded drugs. Requires the Secretary to establish a process for pharmacies to register as compounding pharmacies. Exempts pharmacies that employ fewer than 20 full-time employees and perform traditional compounding of drug products for use in a single state. Requires the Secretary to:
(1) establish a database of information on compounding pharmacies licensed in more than one state for oversight purposes,
(2) establish minimum standards for the safe production of compounded drugs as well as for which drugs must meet those standards, and
(3) conduct regional training for state agencies that regulate compounding pharmacies. Directs the Secretary to establish advisory committees on labeling of compounded drugs and on the database under this Act. Requires the Secretary to convene an Advisory Committee on Pharmacy Compounding as appropriate to consider issues related to the safety and availability of compounded drugs.

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