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Foley says it published an update on HHS’s six-peptide compounding policy
Foley said it published an update on HHS’s limited enforcement discretion policy for compounding with six peptide bulk drug substances. The firm said the article examines the policy’s eligibility conditions and distinguishes enforcement discretion from placement on the statutory bulks list or FDA approval of compounded products.
Key points
- Foley identified William Holtz, Nathan Beaver and David Rosen as the authors.Foley
- The firm said the update addressed manufacturing registration and certificates of analysis.Foley
- Foley said it covered labeling, single-active-ingredient and adverse-event reporting conditions.Foley
- The firm said the article discussed documentation for oral formulations and limits on co-packaged delivery devices.Foley