International Journal of Pharmaceutical Compounding

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FDAMA Proposed List of Agents Not to be Compounded due to Withdrawal for Safety/Efficacy Concerns

Author(s): Allen Loyd V Jr

Issue: Jan/Feb 1999 - Dental Compounding
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Page(s): 25-29

FDAMA Proposed List of Agents Not to be Compounded due to Withdrawal for Safety/Efficacy Concerns Page 1

FDAMA Proposed List of Agents Not to be Compounded due to Withdrawal for Safety/Efficacy Concerns Page 2

FDAMA Proposed List of Agents Not to be Compounded due to Withdrawal for Safety/Efficacy Concerns Page 3

FDAMA Proposed List of Agents Not to be Compounded due to Withdrawal for Safety/Efficacy Concerns Page 4

FDAMA Proposed List of Agents Not to be Compounded due to Withdrawal for Safety/Efficacy Concerns Page 5

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Abstract: The US Food and Drug Administration has proposed that drug products listed in the table provided here be included on the list of drug products withdrawn or removed from the market because they have been found to be unsafe or ineffective. Therefore, compounding a drug product on this list would not be covered by the exemption provided in Section 503A(a) of the Federal Food and Drug Administration Modernization Act of 1997. The list originally appeared in the October 8, 1998, Federal Register (63[195]:54083-54087). Listings are mostly alphabetical. Reasons for withdrawal and withdrawal dates are also provided.

Related Keywords: Safety, Efficacy

Related Categories: LEGAL

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