By Scott Dance, The Baltimore Sun
Batches of sterile drugs from so-called compounding pharmacies will be subject to state review under the measure Gov. Martin O’Malley signed this month. And pharmacists and doctors who perform compounding, in which drugs are somehow altered from their Food and Drug Administration-approved form, will face an extra layer of permits and inspections for drugs used in Maryland.
But “it’s not realistic for Maryland to set up national oversight,” said Joshua M. Sharfstein, the state health secretary.
The legislation is intended as a stopgap while the FDA seeks broader authority to inspect compounding centers that are neither state-regulated pharmacies nor federally regulated manufacturers. Much of the measure could become moot ifCongress grants the FDA that authority — and state officials hope that it does, said Sharfstein, also a former FDA deputy commissioner.
A U.S. Senate committee is set to review draft legislation addressing the regulatory gap Thursday. Some Republicans in Congress argue that the FDA already has the power to regulate compounding operations, while the agency argues its legal authority is unclear.
The FDA and members of the pharmaceutical industry are expected to make their case in a hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions, which includes Sen. Barbara A. Mikulski. Congress first considered legislation on compounding pharmacy regulation in November.
The new state law is one of several O’Malley signed to promote patient safety — others tightened oversight of plastic surgery procedures and required health care staffing agencies to be licensed.
The Maryland law, which takes effect July 1, seeks to promote safety in sterile drugs coming from facilities both inside and outside the state. Drugs require sterility if they are administered via injections into muscles, underneath the skin or directly into the bloodstream.
For 110 Maryland-licensed pharmacies that have already told state regulators they perform compounding of sterile drugs, the law will require an additional permit and more thorough inspections. Out-of-state pharmacies that perform sterile compounding will also face stricter oversight if they send drugs into Maryland.
Pharmacies pay $700 for a pharmacy permit and $600 to renew permits every two years; regulators have not determined how much the new compounding permit will cost. Anyone operating a sterile compounding facility in the state without the permit will face a fine of up to $1,000 and up to a one-year prison sentence upon conviction of the misdemeanor, as well as a civil fine of up to $50,000.
But other types of facilities besides pharmacies produce sterile medications. Some come directly from manufacturers, which are FDA-regulated.
The law covers a separate, unregulated group, like the New England center — facilities that produce large batches of sterile drugs, without a prescription for a specific individual. Drugs from those facilities will no longer be permitted in Maryland without a waiver granted by the state pharmacy board.
The law sets a high bar for the drug waivers, allowing them only with proof of facility inspections and other safeguards and if health officials deem a critical need for the medication. It also sets a two-year expiration for the drug waivers. Information about the waivers will be posted on the pharmacy board’s website.
State health officials said that they don’t know how many waiver applications they expect to receive, but that the information could help federal regulators understand the scope of the gap in oversight.
“FDA’s authority in that area is very confusing,” Sharfstein said. “They’re seeking more explicit authority, and we support that.”
FDA Commissioner Dr. Margaret Hamburg has said a confusing legal landscape, combined with resistance from compounding pharmacies, had hampered her agency’s ability to act on complaints received about the New England center. In hearings held as recently as last month, Hamburg asked Congress to allow the FDA to require compounding pharmacies to register with the agency “so we know who they are and what they do.”
The broader FDA oversight could “at least 90 percent eliminate the need for the waiver provision” in the state law, Naesea said.
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