News & Analysis as of

Drug Compounding DQSA

Quarles & Brady LLP

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

Quarles & Brady LLP on

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

Searcy Denney Scarola Barnhart & Shipley

Compounding Pharmacies -- Are Users of Finasteride for Hair Loss in Danger?

WHAT ARE THEY? Sometimes the needs of a patient are so unique that prescription medications readily available at retail drug stores are not sufficient to combat the illness or treat the condition. An example of such a...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

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

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

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

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

• 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

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

Faegre Drinker Biddle & Reath LLP

Big Issues Front and Center at Annual Conference for the American Society for Pharmacy Law

In the midst of the opioid epidemic, pharmacists and attorneys from across the country gathered last week for the 28th Annual Conference for the American Society for Pharmacy Law (ASPL). The conference brought together...more

Mintz - Health Care Viewpoints

New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products....more

Akerman LLP - Health Law Rx

Recent Legislative Developments Affecting Florida Pharmacies

Florida’s 2015 Legislative Session ushered in two new laws affecting pharmacies: One addressing pharmacist immunizations (HB 279) and the second clarifies that veterinarians are authorized to dispense compounded drugs and...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

Epstein Becker & Green

FDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding

Epstein Becker & Green on

On May 18, 2015, the U.S. Food and Drug Administration (“FDA”) withdrew its 2003 Compliance Policy Guide – Section 608.400, Compounding of Drugs for Use in Animals and signaled new plans to constrain animal drug compounding...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

Holland & Knight LLP

FDA Issues New Drug Compounding and Outsourcing Facility Guidance - The New Policy Documents Clarify FDA's Expectations and...

Holland & Knight LLP on

The FDA issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA). Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the...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

Cooley LLP

FDA Releases Five New Compounding Pharmacy Policy Documents

Cooley LLP on

Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s...more

Akin Gump Strauss Hauer & Feld LLP

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

BakerHostetler

Stop the Presses! Senate Directs FDA to Meet With Stakeholders Before Enforcing Compounding Law

BakerHostetler on

As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance...more

BakerHostetler

FDA Regulation of Compounding Pharmacies: Unsolved Mysteries

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has been busy since the passage of the Drug Quality and Security Act (DQSA) in November 2013. In just five short months, the FDA has issued six warning letters referencing the...more

Polsinelli

FDA Issues First Compounding Pharmacy Warning Letter Under DQSA/503B

Polsinelli on

On January 17, FDA issued its opening sally in the new compounding pharmacy enforcement regime by issuing a Warning Letter to Avella of Deer Valley in Phoenix, AZ. The letter is based on a nearly year-old inspection (February...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"

BakerHostetler on

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

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