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Pharmaceutical Industry › Food and Drug Administration (FDA) › Outsourcing Facilities

Quarles & Brady LLP

FDA Announces Draft Guidance on Outsourcing Facility Sales

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The U.S. Food and Drug Administration (FDA) issued a draft guidance document, June 27, that describes FDA’s current thinking on the prohibition of wholesaling human drugs by a 503B outsourcing facility under the Food, Drugs,...more

Akin Gump Strauss Hauer & Feld LLP

District Court Affirms FDA Policy on Compounding with Bulk Drug Substances—Bringing Much Needed Clarity for the Outsourcing...

Akin Gump Strauss Hauer & Feld LLP on

On August 1, 2019, the U.S. District Court for the District of Columbia affirmed the U.S. Food and Drug Administration’s (FDA’s) decision to exclude the bulk drug substance vasopressin from the agency’s List of Bulk Drug...more

Mintz - Health Care Viewpoints

FDA Invites Compounding Outsourcing Facilities' Comments to Understand Industry Challenges and Opportunities

Mintz - Health Care Viewpoints on

On July 29, 2019, the Food and Drug Administration (FDA) published a notice to the Federal Register (84 Fed. Reg. 36609). The notice invites comments on information collected in connection with FDA research by obtaining...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Criteria, and First Two Exclusions, for Outsourcing Facility Compounding with Bulk Drug Substances

Akin Gump Strauss Hauer & Feld LLP on

• Five years after passage of the DQSA, FDA issued final decisions prohibiting the use of two bulk substances by outsourcing facilities, and finalized criteria for ongoing evaluations of other bulk substances that are...more

Holland & Knight LLP

FDA Issues Draft Guidance on Bulk Substances for Compounding by Outsourcing Facilities

Holland & Knight LLP on

On March 23, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance regarding the process through which it proposes to evaluate bulk drug substances nominated for use in compounding by outsourcing...more

BakerHostetler

Human Drug Compounding: FDA Issues Four Guidance Documents

BakerHostetler on

FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding right before the start of the new year. These guidance documents cover...more

BakerHostetler

FDA Guidance Documents Change Compounding Landscape

BakerHostetler on

Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance...more

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