L. D. King
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Pharmacy industry critics are "gravely concerned" that the Safe Drug Compounding Act of 2007, a draft Senate bill, would sharply
curtail the practice of compounding by giving the Food & Drug Administration authority to regulate compounding. A coalition
of nine pharmacy organizations drafted a letter to the bill's expected sponsors—Senators Edward Kennedy (D, Mass.), Pat Roberts
(R, Kan.), and Richard Burr (R, N.C.)—insisting that the bill "would negatively impact patient access to necessary compounded
prescription medications and create onerous, new requirements for prescribers and pharmacists."
In the letter, the American Pharmacists Association, National Community Pharmacists Association, International Academy of
Compounding Pharmacists (IACP), American College of Apothecaries, American Society of Consultant Pharmacists, National Alliance
of State Pharmacy Associations, Massachusetts Pharmacists Association, North Carolina Association of Pharmacists, and Kansas
Pharmacists Association strongly urged the senators "to reconsider introducing this draft legislation." The groups touted
the work of the U.S. Pharmacopeia, state boards of pharmacy, and the Pharmacy Compounding Accreditation Board (PCAB) and promised
to work with Congress to address concerns about pharmacy compounding.
Larry Sasich
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"State boards of pharmacy have done a great job to write compounding standards," asserted L. D. King, executive director of
IACP. "The PCAB just started. Our emphasis should be on these institutions, not moving power to the FDA. There's no way that
the FDA will be equipped to handle this."
The bill has yet to be introduced, and the likelihood of its passage is unclear. Still some critics worry that the bill may
be added as an amendment to upcoming healthcare or other legislation and may pass without a debate. "We have not seen broad
support to enable the bill to pass as a stand-alone, but we are concerned about it as an amendment," explained King. Several provisions of the Safe Drug Compounding Act of 2007 promise to redefine oversight and regulation of the practice of
compounding. The act gives power to the FDA to inspect all retail pharmacies that make or dispense compounded medications
and to determine whether or not compounded medications are medically necessary or are "essentially copies" of existing FDA-approved
medications. In addition, the act would take a number of steps to inhibit the distribution of compounded medications beyond
state lines. It requires compounding pharmacies to provide detailed documentation on all intrastate orders and asks state
pharmacy boards to "discourage the distribution of inordinate amounts of compound drug products in interstate commerce."
Critics of the bill also contend the bill would potentially come between doctors and their patients by forcing doctors to
prove that the compounded prescription is medically necessary. "It will put up barriers, preventing patients from receiving
medications prescribed by their doctors," insisted King. "We feel that interferes in the doctor-patient relationship."
Compounding critics, on the other hand, were largely pleased with the draft bill and insist that the act would clarify several
issues that have been unclear since 1997 when the Supreme Court struck down portions of the FDA Modernization Act (FDAMA)
dealing with compounding. "Kennedy's bill goes a long way in correcting the problems and dangers we have with pharmacy compounding,"
argued Larry Sasich, Pharm.D., consultant for Public Citizen and assistant professor of pharmacy practice at Lake Erie College
of Osteopathic Medicine School of Pharmacy in Erie, Pa. "This corrects the deficiencies of the 1997 law and addresses everybody's
major concern: patient safety."
Although the bill has not even come to the Senate, pharmacy organizations appear to be girding for a battle. "We have to educate
the senators on the health committee about the unintended consequences this bill will have," said King. "There have been some
petitions from pharmaceutical companies calling on the FDA to regulate compounding. We know that they have tremendous influence
on Capitol Hill. There's no way we can match up with them."
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