Compounding Pharmacies May Face Tougher FDA Regulation, Per Bill

As individuals throughout the United States continue to deal with an outbreak of fungal meningitis from tainted epidural steroid injections mixed at one Massachusetts compounding pharmacy, a congressman is introducing a new bill that would provide the FDA with clearer authority and regulatory powers over the compounding pharmacy industry.

Representative Ed Markey, a Democrat from Massachusetts 7th congressional district, has indicated that he will introduce a bill that is designed to close a “regulatory black hole,” which has resulted in a fragmented regulatory framework between the states and federal officials for compounding pharmacies.

Lax regulations and enforcement actions have been cited as one cause for the recent fungal meningitis outbreak, which has been linked to thousands of vials of medications mixed at the New England Compounding Center (NECC) that were shipped to medical providers in 23 different states.

The Verifying Authority and Legality in Drug (VALID) Compounding Act would give the FDA authority to oversee and regulate compounding pharmacies that operate as mini-drug manufacturers, while preserving the state’s regulatory authority for traditional small compounding pharmacies that only serve local needs.

Compounding pharmacies are speciality pharmacies that mix specific medications and drugs for patients, often changing the dosing or form of the medication to accommodate specific patient needs. While they are designed to serve local medical providers, amid lax regulations, many compounding pharmacies have been producing mass quantities of drugs that are shipped throughout the United States, which is what happened at NECC.

The bill congressman Markey plans on introducing is designed to strengthen federal oversight of compounding pharmacies and close loopholes that prevented the FDA from taking swifter action at the start of the meningitis outbreak. It specifically allows the FDA to regulate compounding pharmacies like a drug manufacturer.

Other provisions of the legislation prevent compounding pharmacies from producing copies of commercially available drugs and requires the pharmacies to label the compounded drugs to indicate they have not been tested by the FDA. Additionally, it requires the FDA to compile a list of drugs that are not effective and often unsafe when compounded.

The death toll from the meningitis outbreak has continued to spread over the past few weeks, reaching 29 late last week.  There are more than 400 confirmed fungal meningitis infections reported in 19 states, and given the long latency period for the fungal infections, new cases continue to be diagnosed and reported every day.

Tainted methylprednisolone acetate, a common steroid used to treat back pain, was found to be the cause of the outbreak.

Following an investigation into the activities at the NECC, the FDA reported a number of problems at the compounding pharmacy, and many have speculated that the outbreak could have been avoided with stronger regulatory actions.

Last week, the FDA confirmed that two additional drugs from NECC were also found to be bacterially contaminated. The discovery raised further concerns regarding the ‘clean room’ at the facility and regulations regarding compounding pharmacies and the production of medications.

Under current law, the FDA is restricted in its ability to regulate compounding pharmacies unless it engages in the equivalent of mass production like a drug manufacturer, which the NECC did do in its production of the steroid.

In the interim, the state Board of Registration in Pharmacy enacted emergency rules stating compounding pharmacies can only produce drugs for individual patient prescriptions and require the pharmacies to submit biannual reports detailing how many prescriptions were dispensed and where. Democratic Rep. Rosa DeLauro from Connecticut also plans to introduce legislation intended to strengthen the FDA’s regulatory authority over compounding pharmacies after the election.