mid ongoing safety concerns over compounding pharmacies, a new analysis finds state oversight is a spotty patchwork of regulations, raising questions about the ability to protect the public health.
Only about half of the states require compounding pharmacies that make sterile medicines, which are injected or infused into the body, to fully comply with recognized quality standards. In addition, 60 percent of the states do not require compounding pharmacies to report serious adverse events and reactions related to sterile compounding, according to the analysis by the Pew Charitable Trusts, a public policy organization.
Moreover, 16 states reported they do not track compounding pharmacy activity at all. And 28 states allow traditional compounding pharmacies — as opposed to those that make large amounts of medicines for hospitals — to provide drugs without prescriptions for individual patients. This practice conflicts with federal law.
“There is notable variation in state oversight,” said Elizabeth Jungman, the Pew director for public health. “Certainly, there’s room for improvement.”
The International Academy of Compounding Pharmacists, a trade group, did not respond to requests for comment. [UPDATE: The trade group sent us a statement saying it supports uniform quality standards recommended by the US Pharmacopeial Convention and agrees with the “study’s theme” that state boards should have primary oversight of compounding practices including those in the pharmacy, physician and hospital setting.”]
The analysis follows controversy surrounding compounding pharmacies. In 2012, more than 750 people in 20 states contracted fungal meningitis from tainted steroids that were made by the New England Compounding Center. The outbreak caused 64 deaths and prompted Congress to pass a law, the Drug Quality and Security Act, which gives the Food and Drug Administration more oversight of compounders.
Traditional compounding involves making a personalized medicine for a patient. But the business has evolved: Some compounding pharmacies manufacture bulk amounts of medications for some physicians and hospitals, and, in this way, act more like conventional drug makers. And so, the law created two classes of compounders.
One class, known as an outsourcing facility, can voluntarily register with the FDA, but then must follow good manufacturing practices. The idea is to give these compounders an incentive to appeal to their customers. In turn, these customers would, presumably, have more confidence in the medicines. Compounders that do not elect to take this step are still subject to FDA oversight.
The law gave the FDA added authority and the agency has since cracked down by increasing the number of inspections, and, in rare cases, taking legal action to halt allegedly unsafe practices. But the primary responsibility for regulating these businesses falls to state authorities, and as Pew noted, laws and regulations are updated at the discretion of each state.
Moreover, Pew found that there appears to be “some uncertainty” among the states about how they should handle compounders that sell sterile medications without individual patient prescriptions but do not register as outsourcing facilities with the FDA. In fact, nine states do not plan on taking any action, such as requiring compounders to register with the FDA or disciplining these businesses.
“I think this is really important issue for patients, because patients too often have been harmed by drugs made by compounding facilities,” said Dr. Michael Carome of Public Citizen.
He added that “These are too many holes in our regulatory framework extending from the federal level to the state level. … It’s not a single loophole – it’s a Swiss cheese.”
What else did Pew find?
State definitions for compounded meds have varying criteria, such as a combination of two or more ingredients, repackaging, reconstitution, diluting, or pooling. As a result, drugs prepared in one state may not be held to the same standard as those prepared in another, depending on the definition. “This has implications for the quality standards applied to products shipped across state lines,” Pew noted.
Pew also noted that only 53 percent of the states conduct annual routine inspections for in-state pharmacies that perform sterile compounding. As for any issues discovered during an inspection, 79 percent of the states requires a written response from the pharmacy describing how the issues were addressed, and 67 percent also need an additional on-site inspection to verify compliance. Another way of looking at this, however, is that one-third of the states do not perform on-site follow-up inspections to verify needed changes.
Another nugget: Most of the states — 88 percent — said they have the authority to issue cease-and-desist orders, but 70 percent also said they were unable to mandate a recall of compounded drugs or were unsure of their explicit authority.
Ike Swetlitz contributed reporting.