ASHP Applauds Passage of Drug Compounding Bill

2013-11-24
Source: American Society of Health System Pharmacists(ASHP)
After months of negotiation, the U.S. Senate just approved H.R. 3204, the Drug Quality and Security Act, which is designed to improve the safety of compounded drug products. The bill clarifies federal oversight for the practice of compounding by reaffirming current law under Section 503A of the Food, Drug and Cosmetic Act (FD&C) and by creating a new section, 503B, that provides Food and Drug Administration (FDA) oversight of large compounding entities known as “outsourcing facilities.”
“Although it is a scaled-back version of earlier legislation, this bill is an important first step in assuring that compounded sterile products are prepared safely,” said ASHP CEO Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP. The bill also contains provisions for tracking pharmaceutical products throughout the supply chain and puts into place a single federal standard which supersedes state laws. The House passed the bill in September and President Obama is expected to sign the bill into law.
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