Pharmacies Food, Drug and Cosmetic Act

News & Analysis as of

A “Too Old” OTC Product Does Not A Class Action Make

This past weekend, we attended a fundraising 5K race organized by a friend who lives with a form of muscular dystrophy. We volunteered to photograph the event, because the usual photographer was not able to attend. And...more

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The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

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FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities.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

Makena Drug Compounding Lawsuit Against FDA Gets New Life

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

Drug Quality and Security Act Creates New Laws for Compounding Pharmacies

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

Key Points: Compounding Quality Act

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

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

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

Congress Passes Compounding Quality Act

The Senate approved a human prescription compounding bill (H.R. 3204) Monday by voice vote, sending it to President Obama for his signature. The bill had been in the works since last year, when a meningitis outbreak from...more

Possible Legislative Changes To Compounding Pharmacies

Often times it seems that compounding pharmacies operate in a "gray area" between state legislative oversight and federal legislative oversight. However, due to the attention created by several sterile compounding pharmacies,...more

Misbranded Drugs: A Danger To Physicians And Patients

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

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The...more

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