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.
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."