503B Drug Compounding Facility

The Drug Quality and Security Act, signed into law on November 27, 2013 creates a new section 503B in the FD&C Act. Under section 503B, a compounder can become an "outsourcing facility". Drugs compounded by an outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not from current good manufacturing practice (cGMP) requirements.

Outsourcing facilities:

  • must comply with cGMP requirements;
  • will be inspected by the FDA according to a risk-based schedule; and
  • must meet certain other conditions, such as reporting adverse events and providing the FDA with certain information about the products they compound.

News Release

As of 2/23/2016, Bioserv Corporation is pleased to announce the successful registration with the FDA as a new Human Drug Compounding Outsourcing Facility under Section 503B of the Federal Food, Drug and Cosmetic Act (FD&C Act).

Bioserv has been inspected by the FDA a total of ten times over the past twelve years as both a drug and medical device manufacturer and has no open issues at this time. Additionally, Bioserv is certified by the International Organization for Standardization (ISO) and is registered with the State of California Department of Public Health Food and Drug Branch. Bioserv has also successfully completed many customer audits during its 25-year history.

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