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Capitol Connections Article API Lists 1.24.14
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IACP Members Submit Nominations for API Review

The Drug Quality and Security Act's reaffirmation of 503A of the Food Drug and Cosmetic Act places certain limitations on the use of bulk ingredients for compounding.  Any API (Active Pharmaceutical Ingredient) must satisfy one of the following three requirements:

  • The drug has a USP/NF monograph.
  • The drug is a component of an FDA approved medication.
  • The drug appears on a list of APIs reviewed and approved by the Secretary of Health and Human Services.

On December 4, 2013, the FDA issued a request to the professional practice community to identify bulk ingredients that don't meet the first two criteria, please click here. IACP members, responding to our request for recommendations from previous newsletters, have identified more than 170 APIs regularly used for preparing patient prescriptions. The preliminary list, click here, will be screened and IACP plans to prepare a dossier on each medication to submit on behalf of the compounding community. As those dossiers are prepared, we will be posting the information so that individual members may also submit these drugs to the FDA for consideration.

What's the next step? Once the lists of APIs have been submitted, the FDA's Pharmacy Compounding Advisory Committee will review and give a recommendation to the Secretary as to whether that particular bulk ingredient should or should not be used in compounding. The Secretary may or may not accept that recommendation and will subsequently publish the bulk ingredients deemed acceptable.  

At the present time, we do not know how long that will take nor what, if any, enforcement action may be taken against a traditional compounder as defined within 503A who continues to compound using a non-monographed, non-approved API prior to the issuance of the Secretary's report. Additionally, we do not know how homeopathic products and many dietary supplements will be handled because they are neither FDA approved nor do they have a USP/NF monograph. IACP is submitting a letter recommending that the FDA hold to its verbal promise to the Senate HELP Committee to recognize the Homeopathic Pharmacopeia of the United States.

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