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11/20/2003

Senate Mulls Oversight of Pharmacy Compounding

Donna Young

Senators Christopher Bond (R-Missouri) and Pat Roberts (R-Kansas) convened a hearing on Capitol Hill on October 23 to explore the adequacy of states’ oversight of pharmacy compounding and whether the federal government should intervene and mandate national regulations.

An FDA official, the president-elect of the American Pharmacists Association (APhA), the executive director of the Missouri Board of Pharmacy, two pharmacists experienced in compounding, and a congressional investigator testified before the Senate Health, Education, Labor, and Pensions (HELP) Committee.

The American Society of Health-System Pharmacists (ASHP) submitted written testimony to the committee.

Bond and Roberts, along with HELP Committee Chairman Judd Gregg (R-New Hampshire), asked the General Accounting Office (GAO) last June to examine issues surrounding the size, scope, and practice of pharmaceutical compounding.

GAO reviewed compounding regulations in four states: Missouri, North Carolina, Vermont, and Wyoming.

Missouri recently began random testing of compounded preparations for safety, quality, and potency. 

Congressional investigators also based their report on discussions with the National Association of Boards of Pharmacy (NABP) and other pharmacy organizations, including ASHP.

GAO submitted its report to the committee at the October 23 hearing.

The report noted that FDA had documented over 200 adverse events involving 71 compounded preparations since 1990.

The agency had obtained information about the adverse events from various sources, GAO said. 

Not an attack. The hearing and report were “not intended to be an attack on the practice of compounding,” Bond exhorted, adding that the committee recognized the vital role that compounded preparations play to ensure that needed medications are available to meet individual patients’ needs.

But, he declared, the committee has received reports about “a significant number of very real problems caused by compounded drugs,” including reports of nonsterile eye drops causing blindness, spinal injections contaminated with bacteria or fungi, and children poisoned as a result of errors in ingredient concentrations.

Those incidents, Bond said, have heightened the committee’s and the public’s concern about the safety and quality of compounded preparations.

Yet when these “types of tragedies occur,” there are very few state laws and no federal law requiring the reporting of adverse events associated with the use of compounded preparations, he said, noting that drug manufacturers are required to report adverse events associated with their products to federal regulators.

It is not the committee’s goal, Bond said, to “federalize the oversight of pharmacists and compounding pharmacists, or institute additional needless and burdensome paperwork and regulatory requirements.”

But, he said, the committee has “a responsibility to ensure that patients and doctors are receiving safe and accurate dosages of compounded drugs.”

“When people get sick, they want to know that their medicine is safe and effective, but most importantly they want to know that it is just what the doctor ordered,” Bond said.

“As our population continues to age, and the demand for pharmaceuticals continues to grow, we have to make sure that appropriate safeguards are in place to protect patients from substandard, contaminated, subpotent, or superpotent drugs so that we can ensure the highest standard of care.”

Oversight. Bond said that because oversight and surveillance of pharmacy compounding at the state and federal levels are “limited at best,” little is known about how widespread the practice of pharmacy compounding is, the ability of states and the federal government to regulate compounding, and how compounding affects public health.

Pharmacist Sarah L. Sellers, a former member of FDA’s defunct advisory committee on pharmacy compounding, testified that “current state compounding regulations are, in some cases, inadequate to protect public health and safety and to prevent individual patient exposures to unacceptable risks.”

Lack of oversight of the “compounding industry,” she asserted, “has created new avenues to introduce commercial quantities of unapproved drugs into the marketplace through wholesale transactions.”

Sellers called on lawmakers to develop and pass legislation that would require compounding pharmacies to fully disclose to patients and prescribers when a prescription is filled with a compounded product and to keep a strict paper trail of all chemicals used in those products.

And, she added, products that are too difficult to be compounded in a pharmacy setting should only be produced by FDA-regulated manufacturing facilities.

Compounding pharmacies should also be required to record and report adverse events associated with their products, Sellers said.

What to consider. Many questions exist about what role state and federal regulators should play in overseeing pharmacy compounding, Roberts said.

“What are we doing at the state level to enforce regulations currently on the books?” the Kansas lawmaker questioned, further asking what can states without adequate regulations do to improve their principles governing pharmacy compounding.

“Are schools of pharmacy properly training individuals to compound, and what steps are they taking to do so safely?” Roberts asked.

APhA President-Elect Daniel A. Herbert responded that, for the most part, schools of pharmacy “are not teaching compounding these days.”

“It’s not part of the curriculum in many schools of pharmacy in the country,” he said. 

But, Herbert added, if states adopt uniform standards for pharmacy compounding, it may “precipitate reinstitution of training programs in schools of pharmacy.”

Uniform standards. ASHP strongly supports the development and widespread distribution of minimum standards and appropriate guidance for pharmacists and others on pharmacy compounding, the Society told the committee in its written testimony.

“While ASHP believes state boards of pharmacy are the appropriate body to enforce compounding standards, the FDA has a role to play in ensuring that the state boards fulfill this responsibility through the state adoption of uniform standards,” the Society affirmed. “ASHP believes that it is appropriate for the FDA to suggest to state boards the standards that the states should apply. This will foster the establishment of a national quality assurance standard for compounding in all pharmacy settings, rather than 50 different standards.”

The existing federal–state partnership provides a good framework for regulating medication distribution, including compounded preparations, said Kathleen M. Cantwell, director of federal legislative affairs for ASHP.

“We should continue to work to strengthen this system to improve patient safety,” she said.

The use of both the United States Pharmacopeia (USP) chapters and ASHP guidelines on sterile and nonsterile compounding, as well as the latest scientific knowledge in the literature, would provide the assurance the committee is seeking for the safety and effectiveness of these preparations, the Society stated. 

GAO acknowledged in its report that some states are taking steps to strengthen oversight and national organizations, including ASHP, are working to develop standards that may strengthen state-level efforts.

“However, the effectiveness of these measures is unknown, and factors, such as available resources, may affect the extent of oversight activities,” GAO’s Janet Heinrich, director of public health issues, told the Senate committee.

“While FDA has authority over the safety and quality of new drugs, it has generally relied on states to regulate drug compounding,” Heinrich said. “Given state resources, we may need to look even more to FDA in the future.”

But Senator John Ensign (R-Nevada) questioned whether an already “overburdened” FDA could shoulder the additional role of inspecting compounding pharmacies.

Heinrich said that in her discussions with FDA officials, “people did say that they’re stretched now to cover their ongoing inspection requirements and that to do more inspections in the area of compounding would be difficult.”

A new concept. Carmen A. Catizone, NABP’s executive director, said his organization has met with USP and other national pharmacy organizations, including ASHP, to discuss development of a new body that could inspect pharmacy compounding facilities and oversee a voluntary accreditation system.

“What we would hope though, is that the FDA and the states would recognize this accreditation rather than develop new legislation,” he said.

The initial reaction from state and federal regulators about the concept, Catizone said, is that it “sounds very good and something that they’d like to look at rather than exploring developing their own programs and having to use state or federal inspectors.”

FDA weighs in. FDA respects the role of states in matters that relate to pharmacy regulation, said Steven K. Galson, acting director of the agency’s Center for Drug Evaluation and Research.

“We also believe that there are areas where a federal role is appropriate,” he testified.

FDA’s role includes maintaining a list of drugs that are inappropriate for compounding because they have been withdrawn from the market for safety reasons, Galson said.

FDA’s responsibilities, he added, also include overseeing the quality of all drug substances used in compounding.

In conjunction with state boards of pharmacy, FDA investigates allegations of poor-quality compounded preparations, Galson said.

It is FDA’s responsibility to determine when a pharmacy crosses the line between appropriate pharmacy compounding and manufacturing, he affirmed.

“We’ve seen abuses such as large-scale drug manufacturing operating under the guise of pharmacy compounding,” Galson declared. “Sometimes compounding appears to occur for economic reasons rather than genuine medical need.”

Compounding large quantities of drugs and copying commercially available products, the agency official contended, “circumvents the important public health requirements of the FDA.”

“This type of compounding undermines the drug approval process, the evidence-based system of drug review that consumers and health professionals rely on for their safe and effective drugs,” Galson concluded.