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FDANonrulemakingFDA-2016-D-2268

Insanitary Conditions at Compounding Facilities

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Parenteral Drug Association filings
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Parenteral Drug Association filed 1 comment on this docket between Oct 13, 2016 and Oct 13, 2016. 21 other organizations filed here. The comment window closed 2801d ago.

What Parenteral Drug Association filed (1)

Oct 13, 2016· Comment from Parenteral Drug Association· FDA-2016-D-2268-0401

The Guidance for Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetic Act, Issued July 2014, cites section 501(a)(2)(B) as not applicable to compounded product under Section 503A, but according to the Guidance for Industry Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B, does apply. This draft guidance identifies section 501(a)(2)(A) as being applicable, and provides the FDA's current thinking on the topic. Further, Guidance for Industry Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B is focused on those aspects that relate to sterility assurance of sterile drug products. The FDA Guidance for Industry, Insanitary Conditions at Compounding Facilities, Draft Guidance does not contain a similar statement that narrows the focus, however the majority of the content of the Guidance is drawn from FDA experience with sterile compounded products. The inference from the flow of the document is that the only section which would be applicable to non-sterile compounding would be Section III., A., 1, Insanitary Conditions Applicable to the Production of Sterile and/or Non-Sterile Drugs. PDA recommends that FDA clarify scope to ensure that other products requiring sterile preparation such as ophthalmic products and wound care products are clearly included. Some comments are identified as "critical" in the attachment because these recommended changes to the text would specifically address and prevent conditions noted in recent FDA Warning Letters to compounding facilities.

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Co-filers (21)

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