Section 503

News & Analysis as of

FDA Establishes Docket for Public Comments on Drug Compounding

The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA...more

D.C. Circuit Rejects Challenge To Section 503 Regulations Administered by OFCCP

On Friday, December 12, 2014, the D.C. Circuit rejected a challenge by Associated Builders and Contractors, Inc. (“ABC”) to the recent rules promulgated by OFCCP under Section 503 of the Rehabilitation Act protecting...more

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

OFCCP Issues Two New “FAQs”

The OFCCP recently added two new “FAQs” to its website to help explain contractors’ obligations under new Section 503 and VEVRAA regulations. The first addresses the information contractors must maintain related to efforts to...more

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