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  1. Human Drug Compounding

FDA Establishes Public Docket on Drug Compounding

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FDA has established a public docket to receive information, recommendations, and comments on matters related to the Agency’s regulation of compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This docket is intended for general comments related to human drug compounding that are not specific to documents or issues that are the subject of other dockets.

Since enactment of the Drug Quality and Security Act, FDA has sought public comment on a number of specific human drug compounding issues and has published numerous Federal Register notices seeking public input.  These have included notices inviting comment on draft guidances on the registration process and product reporting requirements for human drug compounding outsourcing facilities (78 FR 72899 and 78 FR 72897), requesting nominations for the list of drugs that present demonstrable difficulties for compounding (78 FR 72840), and seeking input on other specific matters. A complete list of the human drug compounding policy documents issued by the Agency for public comment can be found on the Compounding Regulatory Policy Information web page. The Agency will continue to seek public comment on specific documents and issues through future Federal Register notices.

However, stakeholders have expressed interest in providing comments and information to FDA on a variety of issues that are not related to the specific regulations, guidance documents or Federal Register notices that FDA has published. FDA has established this public docket so that stakeholders can share information, research, and ideas on any matters related to human drug compounding that are not specific to the documents or issues on which we have already sought public comment in other dockets.

FDA issued a notice in the Federal Register on March 6, 2015, announcing the open docket. The docket will remain open until further notice.

Note: Comments should not be submitted to this general docket if they have already been submitted to specific dockets. Such submissions are duplicative and not helpful to the Agency. If comments on particular documents or issues are submitted to this docket rather than the docket specifically opened for the particular document or issue, the comment might not be considered as the specific documents are being finalized and issues considered. FDA will not respond to questions or requests submitted to this docket but will consider any information submitted in its work to implement the law.

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