The New England Compounding Center is shown here on Oct. 5, 2012. Until the Framingham, Mass., pharmacy landed in the news for the 2012 fungal meningitis outbreak, a lot of folks hadn't heard of these specialized pharmacies.

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Are compounding pharmacies regulated?

Compounding pharmacies don't usually get a lot of media coverage for good news. It's the mistakes -- the deadly outbreaks of meningitis from contaminated vials or the eye infections caused by unsterile medications -- that tend to make the evening news. Turns out, though, that regulatory practices for compounding pharmacies, at least in the United States, tend to follow the same pattern. Until something goes wrong, safeguards aren't generally in place.

First off, let's briefly outline what one of these places is. In the U.S., most drugs and medications are manufactured by large pharmaceutical companies. That means most prescriptions come in bulk: only certain potencies, forms or methods. A compounding pharmacy, however, will create your medication from scratch. Usually that's done for specific reasons: For instance, someone maybe allergic to the red dye in a product, and a compounding pharmacy can mix a prescription that leaves out that inactive ingredient. People often turn to these pharmacists for veterinary needs: Anyone who's ever had to force a pill down a cat's gullet could understand why suspending the drug in a fish-flavored liquid ready for lapping might be a lot easier.

But that ease might come at a price. As of 2012, these specialized pharmacies fell into a kind of gray area of regulation, with state pharmacy boards overseeing both them and regular pharmacies. The U.S. Food and Drug Administration, in turn, focuses more on the big pharmaceutical manufacturers. Sonia Gale, a compound pharmacy director in Washington state, points out that the setup doesn't necessarily cover the safety of a pharmacy.

"Very, very little is regulated by the state," Gale says of Washington state practices. That's because although the state is regulating, it's more concerned with liability issues than specific safety oversight. (That could have something to do with the fact that the state has little knowledge of manufacturing practices [source: Pittman and Smith]). It's left to the pharmacies to regulate their own safety practices and to uphold ethical obligations.

And how do they do that? Let's take a look at the next page to check out some professional organizations and accreditation that compounding pharmacies use to keep their facilities and products safe.

Compounding Pharmacy Regulation and Accreditation

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While the FDA and state regulatory boards historically may not have been terribly stringent when it comes to compounding pharmacies, there are a couple of different organizations to help them maintain strict standards. For example, the International Academy of Compounding Pharmacists (IACP) and the Pharmacy Compounding Accreditation Board (PCAB) are professional organizations that provide accreditation, oversight or information to compounding pharmacies. The Professional Compounding Centers of America (PCCA) offers a range of products and services to compounding pharmacies, including classes accredited by yet another organization, the Accreditation Council for Pharmacy Education. (It's worth noting that the FDA has tried to push through regulation legislation over the past three decades, only to have it stalled by professional organizations and lobbies.)

As we said, state regulation varies when it comes to compounding pharmacies. Private organizations such as the PCAB offer complying pharmacies and pharmacists with some criteria. That includes a few verifications (like that the pharmacy is fully licensed) and on-site evaluations. It could also include education and training for pharmacists and technicians, as well as materials and equipment for compounding pharmacies.

According to pharmacy director Sonia Gale, pharmacies can also use professional associations through the IACP, PCCA and PCAB to test the potency and sterility of medications. "Every single sterile prescription" is tested, according to Gale, from a PCCA-recommended testing facility. Remember, though, that these are voluntary standards, not ones mandated by a state or national agency. In the fungal meningitis outbreak, the facility involved had been reprimanded for ignoring those tests in the past [source: Associated Press].

"Most compounding is not taught in pharmacy schools," says Gale. " ... really each pharmacy sets up their own policies and procedures." For instance, in one pharmacy only certified pharmacists might be able to compound prescriptions; in another, technicians might be doing compounding work, overseen by pharmacists.

So while some compounding pharmacies may go the extra mile to ensure a safe, sterile and healthy environment, let's be clear: No one is really making them. Although with the outbreak of meningitis, don't be surprised if you see a few laws coming their way.

"It's sad to say, but a lot of regulation comes out of something that's happened," Gale says. "It's just too bad that people get hurt."

Author's Note

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It seems to me that compounding pharmacies must be (somewhat frustratingly) taken on a case-by-case basis. Because the FDA is regulating patents and manufacturing and the states' pharmacy boards aren't necessarily set up to oversee the safety of compounding pharmacies, you're left with pharmacies that must set their own strict standards and compliance. Check their accreditations with professional organizations and always practice due diligence when it comes to your health care.

Sources

  • The Associated Press. "Calls to regulate specialty pharmacies." SFGate.com. Oct. 14, 2012. (Oct. 19, 2012) http://www.sfgate.com/business/article/Calls-to-regulate-specialty-pharmacies-3948141.php
  • The Associated Press. "FDA regulation of pharmacies has knotty history." National Public Radio. Oct. 12, 2012. (Oct. 19, 2012) http://www.npr.org/templates/story/story.php?storyId=162801940
  • The Associated Press. "The brothers-in-law at the heart of the meningitis outbreak." NBCNews.com. Oct. 14, 2012. (Oct. 19, 2012) http://vitals.nbcnews.com/_news/2012/10/14/14434211-the-brothers-in-law-at-the-heart-of-the-fungal-meningitis-investigation
  • Begley, Sharon. "Insight: How compounding pharmacies rallied patients to fight regulation." Reuters. Oct. 16, 2012. (Oct. 19, 2012) http://www.reuters.com/article/2012/10/16/us-usa-health-meningitis-compounding-idUSBRE89F05Y20121016
  • Gaffney, Alexander. "Meningitis outbreak places spotlight on FDA's regulation of compounding pharmacies." Regulatory Affairs Professional Society. Oct. 5, 2012. (Oct. 19, 2012) http://www.raps.org/focus-online/news/news-article-view/article/2356/meningitis-outbreak-places-spotlight-on-fdas-regulation-of-compounding-pharmaci.aspx
  • Gale, Sonia. Pharmacy Director (PharmD). Personal interview. Oct. 17, 2012.
  • Grady, Denise; Tavernise, Sabrina and Pollack, Andrew. "In a drug linked to a deadly meningitis outbreak, a question of oversight." The New York Times. Oct. 4, 2012. (Oct. 19, 2012) http://www.nytimes.com/2012/10/05/health/news-analysis-a-question-of-oversight-on-compounding-pharmacies.html?_r=0
  • International Academy of Compounding Pharmacists. "Web site." 2012. (Oct. 19, 2012) http://www.iacprx.org/
  • Johnson, Carolyn Y. and Lazar, Kay. "A close look at compounding pharmacies." The Boston Globe. Oct. 15, 2012. (Oct. 19, 2012) http://bostonglobe.com/metro/2012/10/14/meningitis-outbreak-focuses-attention-niche-compounding-pharmacy-business/dapSiH7vHO4w7PrpZfgeOM/story.html
  • Pharmacy Compounding Accreditation Board. "Web site." 2012. (Oct. 19, 2012) http://www.pcab.org/
  • Pittman, David and Smith, Michael. "Compounding Pharmacies: Where's the Oversight?" MedPage Today. Oct. 12, 2012. (Oct. 19, 2012) http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/35294