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BIO Submits Comments on Interim Guidance on cGMP for Compounding Outsourcing Facilities

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&nbsp;The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the &ldquo;Draft Guidance for Industry on Current Good Manufacturing Practices&mdash;Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act.&rdquo;</p>

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Current Good Manufacturing Practices—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act.”

BIO recommends that the Agency clearly state that this Guidance only applies to small molecule products that are approved under the Federal Food, Drug and Cosmetic Act (FFDCA) and not to biological products approved under the Public Health Service Act (PHSA). Specifically, BIO recommends that the Guidance clearly state that the compounding of biotherapeutic products is not covered under this Guidance because the Compounding Quality Act (CQA) provisions of the Drug Quality and Security Act (DQSA) did not alter current law in regard to the compounding or repackaging of biological products, as noted in previous BIO comments. Accordingly, biological products must meet all of the long-standing pre-market licensure requirements in the PHSA and FFDCA designed to protect the public health.
 
BIO has also previously recommended that biotherapeutic products be placed on the difficult to compound list(s) because of the inherent complexity and interdependence of their manufacturing processes and the fact that the quality and consistency of biotherapeutic products (BTPs) can only be defined and ensured through individual and comprehensive process and product-specific control strategies.