Compounding consult

April 19, 2016

SEEKING to clarify issues around compounding of drugs without a prescription, the US Food and Drug Administration has issued draft guidance proposing new rules. Stakeholders are being invited to comment on the drafts within 90 days, with key issues at stake including quantity supplied, to whom and in what locations. The US has two standards - one (503A) for specific patients, and a more stringent 503B level for non patient-specific orders. Under the draft guidance the FDA says it believes all activities taking place at a registered outsourcing facility at a single geographic location should be subject to 503B and the FDA’s current good manufacturing practices, to ensure drugs made under different standards are not accidentally co-mingled.

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Pharmacy Daily | Compounding consult

Compounding consult

Other recent headlines

PD breaking news – Queensland pharmacies scope of practice pilot expanded

Commbank to help navigate ownership

Littleproud visits Orana Mall

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES