outbreak | The Health Law Firm Blog

Drug Quality and Security Act Boosts FDA Regulations Over Compounding Pharmacies

By Lance O. Leider, J.D., The Health Law Firm

On November 18, 2013, the United States Senate voted to increase federal oversight of compounding pharmacies that produce large volumes of mixed drugs. This bill comes in the wake of last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). Click here to read a previous blog on the meningitis outbreak.

This bill does not give the U.S. Food and Drug Administration (FDA) absolute authority over compounders, but creates significant safeguards.

This particular piece of legislation passed the House of Representatives in September of 2013, passed in the Senate in November 2013, and President Obama signed it into law on November 28, 2013. To read a summary of the Drug Quality and Security Act, click here.

Under Law, Registration with the FDA is […]

By The Health Law Firm|2024-03-14T10:01:15-04:00May 15, 2018|Categories: Compounding pharmacy, Florida Board of Pharmacy, Pharmacy Law|Tags: Board of Pharmacy rules, compounded sterile medications, compounding labs, compounding manufacturing, compounding medications, compounding pharmacy, compounding pharmacy oversight, compounding pharmacy regulations, defense attorney, defense lawyer, FDA inspection, FDA regulation, Florida Board of Pharmacy Compounding Committee, Food and Drug Administration (FDA), health law, health law firm, meningitis, office-use compounding, outbreak, pharmacist, pharmacist attorney, pharmacist lawyer, pharmacy, pharmacy attorney, pharmacy deficiencies, pharmacy inspections, pharmacy lawyer, state board of pharmacy, state inspectors, sterile products, the health law firm, traditional compounding, USP guidelines|1 Comment

Compounding Pharmacies Urged to Sign Up for U.S. Food and Drug Administration Oversight

By Lance O. Leider, J.D., The Health Law Firm

It is estimated there are 3,000 compounding pharmacies in the United States, 14 of which have signed up to be regulated by the U.S. Food and Drug Administration (FDA) under the Drug Quality and Security Act. On January 8, 2014, the commissioner of the FDA sent thousands of letters to hospitals and other medical providers that may buy medicines from the compounding pharmacies. The letters urged providers to encourage compounding pharmacies to register as producers of sterile drugs in an effort to protect the public. The letters also mentioned last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). To read a previous blog on the meningitis outbreak, click here.

In November 2013, the Drug Quality and Security Act was passed. Under the law, […]