Are compounding pharmacies regulated?

Compounding Pharmacy Regulation and Accreditation

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."

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