lunes, 9 de marzo de 2015

FDA Law Blog: FDA Announces Establishment of a Public Docket to Receive General Public Comments on Compounding

FDA Law Blog: FDA Announces Establishment of a Public Docket to Receive General Public Comments on Compounding

Posted: 08 Mar 2015 11:22 PM PDT
By Karla L. Palmer –

On Monday, March 9th FDA published a notice in the Federal Register establishing a public docket to receive information, recommendations, and comments on matters related to the regulation of compounding of human drug products under FDCA sections 503A and 503B.  The 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.”  To the extent that a comment relates a matter for which there is a specific docket – such as nominations for FDA’s so called positive and negative lists of bulk substances to be used in compounding, FDA’s draft standard MOU for interstate shipping of compounds under Section 503A, or comments on FDA’s several compounding draft guidance documents – FDA instructs interested parties to submit comments to that specific docket.   A complete list of the human drug compounding policy documents issued by the Agency for public comment can be found here.

FDA will continue to seek public comment on specific guidance documents and issues as they arise; nevertheless, the Agency believes it would be “useful to have a docket available for submissions of any information related to human drug compounding that may be unrelated to the specific issues and documents published for public comment.”  FDA states that interested parties 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 other Federal Register notices that FDA has published on compounding to date. FDA established the general docket so stakeholders can share information, research, and ideas on any matters not specific to the documents or issues on which FDA has already sought public comment in other dockets.

FDA notes that comments should not be submitted to the general docket if they have already been submitted to specific dockets.   Specifically, “such submissions are duplicative and not helpful to the Agency.”  If comments on particular documents or issues are submitted to the general docket rather than the docket for the particular document or issue, FDA states that the comment might not be considered as the specific documents are being considered and finalized.  In addition, FDA will not respond to questions or requests submitted to the general docket but will “consider any information submitted in its work to implement the law.”

The general public docket does not have a date buy which comments must be received; FDA instead states that comments may be submitted at any time.  Comments should be identified by Docket No. [FDA-2015-N-0030], and may be submitted electronically at, or in hard copy to:  Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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