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News & Press: Breaking News

Advisory Committee Votes on Four Bulk Ingredients

Wednesday, June 17, 2015   (0 Comments)
Posted by: Dagmar Anderson
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BREAKING NEWS:

 

IACP representatives David Miller, CEO/EVP, and Cynthia Blankenship, VP Government Affairs, are reporting direct from the FDA's Pharmacy Compounding Advisory Committee (PCAC) meeting in White Oak, Maryland...

This afternoon, the PCAC considered four APIs which do not have a USP/NF monograph or are not a component of a current or previously approved FDA manufactured drug product. Under 503A, compounding using bulk ingredients that lack monograph or approval status is permitted once the FDA and the Secretary of Health and Human Services consider submitted drugs and those are reviewed and decided upon by the FDA PCAC. The Committee did not consider any bulk ingredients for 503B outsourcing facilities; their decision today is only for traditional compounders.

The four drugs considered, the FDA's proposed recommendation, and the Advisory Committee's decision were:

Brilliant Blue G
-- The FDA recommended to permit compounding of Brilliant Blue G from bulk ingredients.
-- The PCAC concurred and recommended adding Brilliant Blue G to the list of drugs that may be compounded using APIs.

Tranilast  
-- The FDA recommended NOT to permit compounding of tranilast from bulk ingredients.
--  The PCAC disagreed and recommended adding tranilast to the list of drugs that may be compounded using APIs. The Committee did, however, recommend limiting its use to only topical use and not for oral dosage forms.

Oxitriptan
-- The FDA recommended NOT to permit compounding of oxitriptan from bulk ingredients.
-- The PCAC concurred and declined to add oxitriptan to the list of drugs that may be compounded using an API.

N-Acetyl-D-Glucosamine
--  The FDA recommended to permit compounding of N-ADG from bulk ingredients.
--  The PCAC concurred and recommended adding N-ADG to the list of drugs that may be compounded using APIs.

Even though the PCAC reviewed and voted on these APIs, there is still a process that requires the FDA to publish the final recommendations, which may include an additional opportunity for public input or comments, before these decisions go into effect.  

Watch for more information from IACP tomorrow when the PCAC reconvenes to discuss the "demonstrably difficult" criteria.



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