David G. Miller June 5, 2014 Specialized Pharmacies Are Regulated by States

 

The Arizona Republic took an important step in exploring issues relating to the Food and Drug Administration's implementation of the new federal Drug Quality and Security Act ("FDA cites 2 Arizona makers of drugs," May 28.
The story, however, created a misperception that compounding pharmacies are "totally unregulated." With or without the new federal law, states have always heavily regulated and overseen pharmacies.
The fact that the Massachusetts Board of Pharmacy has acknowledged before Congress that it failed to properly follow its regulations and inspect and oversee the New England Compounding Centerhas little to do with the state of regulatory oversight nationwide.
The FDA needs to act more quickly in issuing regulatory guidance so that large-scale compounding pharmacies (or outsourcing facilities) that make sterile medications and ship them interstate know what is expected of them.
These facilities have an important role to play in meeting demand caused by drug shortages and the need for customized medications, and they want to meet that demand safely and responsibly.
The FDA also needs to show prompt leadership on the issue of outsourcing facilities being regulated by states in addition to the federal government.
Confusion over federal and state regulation is partly responsible for what led to the NECC issues.
The Republic's story needlessly created concern among patients, many of whom depend on these vital medications for their survival. We wish the story had explored the broader and deeper context of this important issue.
— David G. Miller, Missouri City, Texas
The writer is executive vice president and CEO of the International Academy of Compounding Pharmacists.

quoted from here