FDA Clarifies Compounding Rules

  • April 25, 2016

The Food and Drug Administration issued three draft guidance documents on Friday that answer providers’ and pharmacists’ burning questions about drug compounding standards.

The proposed rules clarify the amount of drugs that providers can compound without a prescription, set requirements for health system compounding pharmacies and clarify how large-scale compounding sites known as “outsourcing facilities” may be set up. This follows two reports from the Pew Charitable Trusts that found compounding oversight is largely left up to the states and varies widely. Read more

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