Pharmacy News

FDA, States Discuss Pharmacy Compounding Regulatory Framework

[February 1, 2013, AJHP News]

Kate Traynor

BETHESDA, MD 14 Jan 2013—FDA officials and representatives from all 50 states and the District of Columbia met December 19 to discuss state and federal roles in the oversight of compounding pharmacies.

FDA Commissioner Margaret A. Hamburg said the meeting was not intended to produce a consensus but instead to help the agency better understand gaps in regulatory oversight and identify new areas where a federal role may be appropriate.

Most of the all-day meeting consisted of group discussions among state pharmacy board representatives, grouped by regions, and was closed to the public. During the last two hours, pharmacy board officials presented a public synopsis of the group discussions.

In the states. State pharmacy boards painted a mixed picture of their current ability to adequately oversee pharmacy compounding.

John C. Kirtley, executive director of the Arkansas State Board of Pharmacy, said pharmacy boards in his region feel comfortable about their ability to regulate their local pharmacies.

But he said pharmacies that do business across state lines are "a point of concern" for state regulators.

"We don't necessarily know about what is happening at specific pharmacies in other states that ship into our states," he said.

Pharmacies, like wholesalers and manufacturers, generally need to be licensed to operate in each state to which they ship products.

Cody Wiberg, executive director of the Minnesota Board of Pharmacy, said that until recently, pharmacy boards have depended on a pharmacy's home state board to adequately regulate entities licensed to do business outside that state.

The meningitis outbreak in patients treated with methylprednisolone acetate prepared by the New England Compounding Center (NECC) of Framingham, Massachusetts, exposed flaws with that mindset.

On the date of FDA's meeting, the outbreak's case count totaled 39 deaths among 620 patients in 19 states who had been sickened with meningitis or other infections. More than 14,000 people may have been treated with the medications blamed for the outbreak, according to federal public health officials.

Wiberg said most states have the resources and authority to safely oversee "traditional compounding pursuant to a prescription."

But when it comes to regulating entities like NECC that engage in large-scale nontraditional activities, he said, "fewer states may have the resources to do that."

"In the latter case, the facilities like NECC, there is a role for the FDA to be involved," Wiberg said.

"There's been some discussion that large volumes that are not produced per prescriptions, that cross state lines, that there ought to be some FDA oversight on that," Kirtley likewise said.

FDA chief Hamburg emphasized that the agency is not seeking sole authority over pharmaceutical compounding.

"The states play a fundamental role in the oversight of traditional compounding, and they should continue to do so," Hamburg said.

But she said FDA has seen an increase in recent years in reports of adverse events related to the large-scale compounding of sterile products from nonsterile ingredients.

Hamburg said FDA needs to proactively identify dangerous practices at compounding pharmacies before patients are harmed rather than reacting after a crisis occurs.

And she indicated that FDA has learned from its experiences as the recent compounding tragedy has unfolded.

"One of the things that we heard consistently and clearly was the need for greater communication" between FDA and state regulators, Hamburg said.

Funding. Carmen A. Catizone, executive director of the National Association of State Boards of Pharmacy, said in December that state regulators lack the funding to properly inspect all of the pharmacies in their jurisdiction [see January 15, 2013, AJHP News].

Wiberg acknowledged that funding issues have been a concern for state boards of pharmacy over the past decade.

"There has been a constant fight to retain our resources, to retain our staffing, to retain our appropriations," he said.

Jay Campbell, executive director of the North Carolina Board of Pharmacy, said state governments need to adequately fund their pharmacy boards. In particular, he said, licensing fees collected by the boards should be used to ensure patient safety and not "regarded as vehicles for revenue."

Definitions. FDA has clear jurisdiction over drug manufacturers, but state pharmacy boards have traditionally regulated the practice of pharmacy compounding.

Hamburg underwent two days of grilling last November from Congress, with some legislators saying FDA should have treated NECC as a manufacturer and taken action against the company. She said FDA was hampered by ambiguity over whether the agency has the authority to act against a compounding pharmacy whose practices are akin to drug manufacturing.

Underlying this issue, Wiberg said, is the lack of clarity on differences between compounding from manufacturing.

In the case of NECC, "should the activities they were engaged in be classified as nontraditional compounding or nontraditional manufacturing?" he asked.

He and others said pharmacy boards would benefit from having clear definitions from FDA to help classify these activities and determine who should be primarily responsible for regulating specific pharmacies.

During her November testimony before Congress, Hamburg asked legislators to support a "risk-based framework" for regulating pharmacy compounding. Under that framework, traditional compounding would remain under state regulation, compounding practices that are deemed nontraditional would be regulated by FDA, and some sterile compounders would need to follow the Good Manufacturing Practices required of drug manufacturers.

More recently, the consumer advocacy group Public Citizen on December 18 released a letter to Health and Human Services Secretary Kathleen Sebelius opposing Hamburg's proposal. The letter stated that FDA's proposal obscures the line between traditional and nontraditional compounding and would further confuse the regulatory landscape.

A docket for comments on the framework was available through January 18.

"We are eager for input from any and all who want to sharer their perspective, experiences, and ideas on this critical issue of pharmacy compounding," Hamburg said.


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