HR 6638 · 112th Congress · Health
S.A.F.E. Compounded Drugs Act of 2012
Bill Progress
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Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to the Subcommittee on Health.(2012-12-07)
Plain Language Summary
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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 mo…
Summarized by Claude AI · Non-partisan · For informational purposes only