FDA sends interim peptide compounding access policy to White House for review
The Alliance for Pharmacy Compounding says the text is not public, so covered peptides and any conditions remain unknown.
DO
By Daniel Okafor · Regulatory Correspondent
Oct 16 10:49 ETSource: Alliance for Pharmacy Compounding
The wire
- 01A federal regulatory review listing shows FDA submitted an action titled "Interim Access Policy for Compounding Using Certain Peptides" to the Office of Management and Budget.
- 02Compounders and prescribers have waited years for clarity on which peptides may be compounded; the policy could set the terms for 503A and 503B peptide work.
- 03APC says it does not know which peptides are covered or when the policy will publish, and cites unconfirmed reports of more than 50 HHS actions backlogged at OMB.
From the source
Read at a4pc.orgPeptide policy now under White House review
Something is definitely stirring on the peptide front.
