Who Should Regulate Compounding?

In testimony before a congressional committee, the International Academy of Compounding Pharmacists' chief executive officer said that his group would cooperate with lawmakers investigating compounding pharmacies, but he also said that the FDA and state regulators already have strong enough laws at their disposal to shut down unsafe pharmacies. FDA Commissioner Margaret Hamburg, MD, said compounders have repeatedly fought the FDA’s authority in court and stronger laws are needed.

What should Congress do and what should state boards of pharmacy do in light of the New England Compounding Center disaster?

Will new federal laws or state regulations lead to better enforcement or not? I come down on the side that says we don’t need new laws—we just need to enforce the ones we have. The other side might say that the current situation is at best confusing. So we need to clarify who we want to be in charge and what we want them to be in charge of.

Is compounding truly a part of the practice of pharmacy and thus should remain under the control of each state’s pharmacy practice act? I think it is and so it should be governed by each state’s board of pharmacy. When it ceases to be compounding and becomes manufacturing, then it should be under the FDA.

I thought that was what we had in place now. Could the issue be that some agency didn’t do its job right? Rather than create new rules and laws, maybe we ought to focus on doing better what we are already empowered to do. What do you think?

More Pharmacy Times coverage of the controversy over compounding pharmacies:

• Meningitis Outbreak Linked to Drug Shortages
• VALID Compounding Act Would Introduce FDA Supervision
• Initial Reports Detail Lapses at Compounding Pharmacy Behind Meningitis Outbreak
• Meningitis Outbreak Linked to Compounding Pharmacy Continues to Grow