For the compounders among us, we’ve got two updates for you today. The first has to do with NCPA’s comments on the FDA’s “demonstrably difficult to compound” proposed rule, and the second with a public meeting last week at which an NCPA member criticized the agency’s Pharmacy Compounding Advisory Committee process. Read more …
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On Monday, NCPA submitted comments to FDA on its Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act proposed rule. The rule, if finalized, would establish criteria for two lists of drug products or categories of drug products that present demonstrable difficulties for compounding, and therefore may not be compounded under either section 503A or section 503B. In our comments, we oppose this proposed rule, and stress that FDA should not finalize it for several reasons, including: 1) the proposed rule had an insufficient notice and comment period; 2) the FDA did not provide evidence behind the demonstrably difficult to compound lists; and 3) the FDA lacked statutory authority to add “categories” to the 503A list.
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Last week, NCPA member A.J. Day presented at FDA’s public meeting that focused on optimizing the agency’s use of and processes for advisory committees. In his presentation, A.J. addressed the many challenges of participation in the FDA’s Pharmacy Compounding Advisory Committee process, including short notification timelines, short timelines to submit nominator slides, and restrictive times for nominators to respond to FDA concerns in formal presentations. NCPA staff Steve Postal was also present at the meeting. For our comments to the last PCAC committee, click here.
