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Pharmacies Federal Food Drug and Cosmetic Act (FFDCA) 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 Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

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On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

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On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

Bass, Berry & Sims PLC

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

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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

Troutman Pepper

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

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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

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

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

Polsinelli

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

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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

Troutman Pepper

EPA'S Hazardous Waste Pharmaceuticals Rules May Impose Significant Burdens on Health Care Facilities - Comment Period Runs Until...

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The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more

Alston & Bird

EPA Proposes New Standards for Hazardous Waste Pharmaceuticals

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The Environmental Protection Agency (EPA) released its proposed Management Standards for Hazardous Waste Pharmaceuticals Rule. If finalized, it will create an entirely new subpart in the Resource Conservation and Recovery Act...more

BakerHostetler

FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

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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

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

K&L Gates LLP

Makena Drug Compounding Lawsuit Against FDA Gets New Life

K&L Gates LLP on

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

BakerHostetler

Special Edition: Health Law Update: Senate Passes "Drug Quality and Security Act"

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On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration's (FDA) oversight of compounding pharmacies in light of last year's...more

Troutman Pepper

Misbranded Drugs: A Danger To Physicians And Patients

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Mail-order businesses, including pharmacies, bombard doctors by fax, phone, and Internet offering an assortment of name-brand medications and treatments at bargain prices. These new options tempt physicians with the promise...more

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