News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Drug Compounding Pharmaceutical Industry

Gardner Law

FDA Issues Numerous Warning Letters

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The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Quarles & Brady LLP

FDA Releases Draft Interim Guidance on Bulk Drug Substances in Compounding Under Sections 503A and 503B of FDCA

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The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more

Quarles & Brady LLP

FDA Publishes New Guidance on Compounding Animal Drugs from Bulk Drug Substances

Quarles & Brady LLP on

The wait is finally over. On April 14, 2022, the Food and Drug Administration (FDA) published its guidance for industry #256 (GFI 256), describing FDA’s position on the legality of compounding animal drugs from bulk...more

Hogan Lovells

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

Hogan Lovells on

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more

Bass, Berry & Sims PLC

FDA Announces Availability of the Standard Memorandum of Understanding for Signature by States – the 365 Day Countdown to 5%...

Bass, Berry & Sims PLC on

The U.S. Food and Drug Administration (FDA) announced October 26 the availability for the signing of the final standard Memorandum of Understanding Addressing Certain Distribution of Compounded Human Drug Products (MOU)...more

Foley Hoag LLP - White Collar Law &...

First Circuit's New England Compounding Center Decisions Illustrate Reach of Federal Criminal Law

In 2012, New England Compounding Center (“NECC”) shipped contaminated anti-pain medication to hospitals and clinics around the country, with devastating consequences. Patients around the country developed fungal meningitis...more

Troutman Pepper

Pioneer Drug Maker Throws First Punch At Pharmacy Outsourcing Facilities (503b)

Troutman Pepper on

Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Warning Letter for Refusal to Permit Inspection: Important Takeaways for Startups and Drug and Device Manufacturers

Introduction: CGMPs and FDA Inspections - Current Good Manufacturing Practices (CGMPs) are mandated by regulations enforced by the U.S. Food and Drug Administration (FDA), and must be implemented and followed by...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...

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

OIG Report Finds a Small Percentage of Hospitals Do Not Obtain Compounded Drugs from FDA-Registered Outsourcing Facilities

On June 6, 2019, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a report that found that, among a sample U.S. hospitals that obtained non-patient-specific (NPS) compounded drugs...more

Akin Gump Strauss Hauer & Feld LLP

The DQSA: Five Years In - Part One of Two

November 27, 2018 marked five years since President Obama signed the Drug Quality and Security Act (DQSA) into law. The law addresses two distinct areas of drug oversight, but it was the combined concerns about the quality...more

Husch Blackwell LLP

FDA Publishes Revised Draft MOU Addressing State And Federal Oversight Of 503A Compounding Pharmacies

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On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded...more

Akin Gump Strauss Hauer & Feld LLP

FDA Releases Revised Memorandum of Understanding That Would Ease Restrictions on Interstate Shipment of Compounded Drugs

• FDA has put out a new draft MOU for stakeholders to review and provide comments over the next 90 days. • If a state enters into the proposed MOU, pharmacies within its borders would be allowed to distribute up to 50...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

Robinson+Cole Health Law Diagnosis

FDA’s New Draft Guidance on Bulk Drug Substances in Compounding

This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...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

Polsinelli

Key Takeaways from FDA's New Guidance for Prescription Drug Compounders

Polsinelli on

On April 15, 2016, the Food and Drug Administration (FDA) released draft guidance that describes the FDA's interpretation of drug compounding standards under Sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act)....more

BakerHostetler

FDA Committee to Continue Considering Drug Compounding Issues

BakerHostetler on

The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on compounded drugs is slated to continue its examination of matters concerning access...more

BakerHostetler

FDA Establishes Docket for Public Comments on Drug Compounding

BakerHostetler on

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

BakerHostetler

FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

BakerHostetler on

Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate...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

Akin Gump Strauss Hauer & Feld LLP

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

BakerHostetler

FDA Releases Compounding Policy Documents

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and...more

K&L Gates LLP

Makena Drug Compounding Lawsuit Against FDA Gets New Life

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On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more

Burr & Forman

Drug Quality And Security Act

Burr & Forman on

On Wednesday, Nov. 27, 2013, President Obama signed the Drug Quality and Security Act (the "Act"). The Act is an attempt by Congress to bring some compounding pharmacies that use certain bulk products under more federal...more

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