News & Analysis as of

Pharmacies Registration

Guidepost Solutions LLC

Navigating the DEA Registration Application Process

Did you know that the United States currently has over 2 million Drug Enforcement Administration (DEA) registrants engaging in activities with controlled substances? Whether you’re a student in residency, a healthcare...more

Foley & Lardner LLP

Revoking Controlled Substances Registrations: the DEA’s Weapon to Fight Abusive Prescribing and Dispensing

Foley & Lardner LLP on

In response to the opioid crisis, the Drug Enforcement Administration (DEA) is cracking down on pharmacies, pharmacists, and prescribers by leveraging an old enforcement weapon: revocation of controlled substance...more

BakerHostetler

New Guidance for 503B Outsourcing Facilities

BakerHostetler on

Three guidance documents recently issued by the Food and Drug Administration (FDA) provide greater clarity for certain entities that compound sterile drugs. The new guidance addresses registration requirements, fees and drug...more

Akin Gump Strauss Hauer & Feld LLP

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FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities.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

King & Spalding

Drug Quality and Security Act Creates New Laws for Compounding Pharmacies

King & Spalding on

On November 27, 2013, the Drug Quality and Security Act was signed into law. This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new...more

Polsinelli

Key Points: Compounding Quality Act

Polsinelli on

The Compounding Quality Act (CQA) amends the U.S. Food, Drug & Cosmetic Act (Act) to create a new, voluntary category of compounders called "outsourcing facilities" (OF). Compounded drugs are those mixed by a pharmacist that...more

K&L Gates LLP

Congress Passes New Drug Compounding Law Increasing Federal Oversight Over Compounding Pharmacies

K&L Gates LLP on

In the fall of 2012, a meningitis outbreak sickened more than 750 people, killing 64 people and leaving many others with pain and nerve damage. The meningitis was traced back to tainted injectable steroids manufactured at a...more

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