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Bill Would Further Involve FDA in Drug Compounding Oversight

By November 6, 2012

U.S. Rep. Ed Markey, whose Massachusetts district is home to the town where the New England Compounding Center prepared and shipped the tainted steroid injections blamed for causing a deadly fungal meningitis outbreak, has made good on his promise to introduce legislation to give the U.S. Food and Drug Administration additional roles in overseeing drug compounding.

Sterile pharmacy compounding The bill, filed on Nov. 2, 212, is titled the Verifying Authority and Legality in Drug (VALID) Compounding Act.

As its name implies, the legislative proposal would mostly impose new paperwork and reporting requirements on compounding pharmacies, pharmacists and pharmacy technicians. Per my own reading of existing law outlining FDA authority in this area, though, the bill would not change much in terms of what pharmacy practitioners and federal or state regulators actually do day-to-day.

Still, Markey argues for the necessity of his legislation because it "ends [a] regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies."

The lawmaker was describing two perceived gaps in federal oversight of drug compounding. The first is that state legislatures and pharmacy boards have principal authority for setting and enforcing practice rules for pharmacies and pharmacy professionals. That would not change if the VALID Compounding Act became law. The draft bill stipulates that states, not FDA, will continue taking the lead in regulating compounding.

The second gap implied by Markey is that no law, at any level, specifically defines requirements for preparing sterile compounded drugs. Rather, federal and state regulators rely on pharmacists and technicians to adhere to a professional standard known as USP 797 when doing sterile compounding. That also would not change under Markey's proposal.

Four things would be different for pharmacy if the VALID Compounding Act is enacted:
  • Pharmacies would have to apply for an FDA waiver to compound drugs with identified shortages.
  • Pharmacies would have to apply for an FDA waiver to compound drugs in small batches when expecting prescription orders, and also when preparing custom-made dosages for an individual patients for a year or longer.
  • Pharmacies would be required to label vials or bags of compounded drugs as not approved by FDA.
  • Pharmacy practitioners who become aware of an adverse event possibly caused by a compounded medication would have to report the incident to the FDA.
The VALID Compounding Act contains language requiring FDA to crack down on compounding pharmacies operating on a scale that makes them more like pharmaceutical manufacturers. The bill does not, however, require pharmacies to report compound prescription volumes to federal authorities.

Emergency pharmacy regulations issued by the Massachusetts Board of Pharmacy on Nov. 1 do require that reporting of prescription volume. Other state boards may follow suit, but it remains unclear whether the information would be shared regularly or consistently with FDA personnel.

Markey has scheduled a House Energy and Commerce Committee hearing on his bill and other issues related to NECC case for Nov. 14. FDA Commissioner Margaret Hamburg is scheduled to testify. Attendances by other witnesses, including NECC's owner, remain to be confirmed.

Regardless of what happens during the hearing or what action the committee takes on Markey's bill, the VALID Compounding Act has little to no chance of becoming law before the end of this year, when the current Congress goes out of session permanently. The priority for House and Senate members has to be resolving critical tax and budget issues -- including not having a budget -- that have proved intractable since January 2011.

To get final action on the VALID Compounding Act, Markey would have to win reelection today (which is very likely), then reintroduce the bill in the 113th Congress.

Do you believe Markey's legislation is necessary? s it likely to ever become law? Would the VALID Act greatly affect what you do as a compounder? If you're a pharmacy regulator, what would the new legislation mean for you?

Photo courtesy of the U.S. Food and Drug Administration

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