Congress passes new regulations on compounding pharmacies

[ProSense]

Congress passes new regulations on compounding pharmacies

by Christian Dem in NC

Earlier today, the Senate passed a bill that would introduce new regulations for compounding pharmacies. This came on the heels of a meningitis outbreak caused by tainted drugs that came out of the now-shuttered New England Compounding Center.

The Drug Quality and Security Act would give large-scale compounding pharmacies the option to register with the Food and Drug Administration and adhere to stricter guidelines for testing and maintaining quality and sterility. In early versions of the bill, these were called "compounding manufacturers," which compounding critics were quick to note suggests that they should be treated like other drug manufacturers and adhere to mandatory guidelines, which the bill does not require. In later versions of the bill, the language was toned down to "outsourcing facilities."

Supporters of the bill hope that compounding pharmacists will want to register with the FDA because doctors will prefer to use compounding pharmacists perceived as safer. Opponents fear compounders won't do it if it's not mandatory.

That's not the only potential loophole in this bill. Michael Carome, head of health research at Public Citizen, thinks this bill could potentially make compounded drugs less safe.

Carome said he opposes the bill because he said it legalizes a practice that was once illegal -- large scale compounding without individual prescriptions and without following the strictest quality and sterility guidelines that drug manufacturers must follow.

"It makes no sense to have two different tiers of drug manufacturers -- one that has to meet all the manufacturing guidelines and one that only has to meet some of them," Carome said. "We believe in a level playing field."

Traditional compounding pharmacies make drugs for one patient at a time because those patients can't swallow pills, are allergic to an ingredient or have some other special need that prevents them from taking the standard drug. But in recent decades, compounding pharmacists have increasingly made drugs on a scale similar to that of a drug manufacturer, meaning they don't always have prescriptions for individual patients.

"When you mass produce a large number of standard doses of a drug in a single batch, if quality fails, a potential to harm many more people exist," Carome said.

All things considered, this bill sounds like a start. Hopefully the holes in it can be fixed later.

http://www.dailykos.com/story/2013/11/18/1256575/-Congress-passes-new-regulations-on-compounding-pharmacies

Statement by Senator Warren on Senate Passage of Pharmaceutical Compounding Legislation

Nov 18, 2013

Washington, DC - United States Senator Elizabeth Warren today released the following statement after the Senate voted to pass the Drug Quality and Security Act:

"I am proud to have worked together with Chairman Harkin, Ranking Member Alexander and all of the Senators on the HELP Committee from both sides of the aisle over several months to develop this law, which will create common sense oversight of the pharmaceutical compounding industry and the pharmaceutical supply chain. For too long, bad actors in the compounding industry have taken advantage of lax state enforcement and confusion about federal regulations. The consequences of too little regulation and too little enforcement were brought into sharp focus last year when a compounding pharmacy in Massachusetts, the New England Compounding Center, was identified as the source of a widespread fungal meningitis outbreak that sickened 751 people and killed 64. The bill strengthens current law over compounding pharmacies and establishes tough, new regulations on large scale facilities like the New England Compounding Center. It also creates an important new oversight system to ensure we have a secure supply chain for our pharmaceutical products. This bill is a big step forward in making people's drugs safer. I commend my colleagues for stepping up to the challenge and showing that it is possible for Congress to do what is right - pass commonsense reforms that protect patients and consumers from harm."

http://www.warren.senate.gov/?p=press_release&id=290

[djean111]

1. I am more scared of the large scale compounding drugs than the supplements I am told to be

frightened about. I don't think supplements have caused any large scale meningitis outbreaks, for instance.

[hatrack]

2. Sounds like a big honking loophole or three . . .

A start, but still, 64 deaths, and the best they can do is some half-assed two-tier compounding system? Meh.

[ProSense]

3. It's interesting that such a bill can

pass both the House and Senate without a peep when people have such strong opinions (see the D-Kos comments) about it.