Report flags safety concerns as FDA weighs compounded peptide injections
Coverage examines what it would mean for patients if pharmacies could prepare injectable peptides that have never been FDA approved.
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By Daniel Okafor · Regulatory Correspondent
Oct 16 00:39 ETSource: Health and Me
The wire
- 01The piece examines the FDA's consideration of allowing pharmacies to compound certain unapproved peptide injections and the safety questions that would follow.
- 02Compounding eligibility is not FDA approval and carries no finding that a peptide is safe or effective for its promoted uses, a distinction clinicians will have to explain to patients.
- 03No new agency action is reported here; the formal rulemaking, including proposed rule and comment period, is still ahead.
From the source
Read at healthandme.comUS FDA May Allow Pharmacies To Make Unapproved Peptide Injections: What Are the Safety Concerns?
