American Medical News
By — Posted July 1, 2013
Chicago Compounding pharmacies should comply with tighter restrictions, according to a report approved by the American Medical Association House of Delegates.
The house adopted a report with recommendations that compounding pharmacies comply with current U.S. Pharmacopeia and National Formulary compounding regulations concerning uniformity, quality and safety. The report also encourages state boards of pharmacy, which regulate the traditional compounding pharmacy industry, to require those pharmacies to adhere to sterile compounding practices. The report further recommends that large compounding pharmacies that introduce drugs into interstate commerce be regulated by the U.S. Food and Drug Administration.
The report, approved at the AMA Annual Meeting in June, was heavily debated during reference committee testimony, as some doctors argued that tighter restrictions could limit their access to compounded pharmacy products, placing patients at risk of not receiving necessary treatments in adequate time.
Compounding refers to the act of combining, mixing or altering pharmaceutical ingredients to prepare a customized medication for a patient. Traditional compounding is done by pharmacists for individual prescriptions. The AMA wants compounding facilities that mass produce compounded products to be recognized as “compounding manufacturers” that are subject to FDA regulations.
The reference committee said the report was prepared in response to widespread concerns about the safety of pharmacy compounding and the extent to which the products were deeply embedded in the U.S. health care system. The issue arose in 2012 when a meningitis outbreak that killed 58 people and sickened 700 others was linked to a compounded injectable product manufactured in Massachusetts.
According to the FDA, compounding, “if done properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication.” Several ophthalmologists underscored this point during testimony when they spoke of the need for compounded medications to treat conditions such as macular degeneration, which could lead to loss of sight if treatment is delayed. Physicians buy these drugs to keep on hand in the office for such cases.
Sam Solish, MD, chair of the AMA Ophthalmology Section Council, said the section supported the concept of the report but said compounded drugs are essential to many ophthalmology practices, since some antibiotics needed for the eyes are available only in compounded form. Doctors must have those medications on hand to treat patients at the time of diagnosis, said Dr. Solish, who practices in Portland, Maine.
Ed Bryant, MD, an ophthalmologist from West Memphis, Ark., and an alternate delegate for the Arkansas Medical Society, said his practice is more than 1½ hours away from any compounding pharmacies. “I have to have these drug in supply in my office. There's no way many of my patients could make it to a compounding pharmacy. If we don't have this, there will be many patients in my practice that will have vision loss. There's no doubt.”
Language was added to the original report to support the view that allowances must be made to meet anticipated needs, including urgent and emergency cases. David Ball, spokesman for the International Academy of Compounding Pharmacists, said the academy was glad that there was discussion of the needs for compounded products in emergency situations. He said compounded medications also are used by pediatricians as a local, topical anesthetic to reduce pain immediately when a child has a wound that requires suturing.
The same day delegates approved the report, former Health and Human Services' Secretary Tommy Thompson announced the formation of an organization to push Congress for compounding reform. Thompson is throwing his support behind legislation co-sponsored by Sens. Pat Roberts (R, Kansas), Lamar Alexander (R, Tenn.), Tom Harkin (D, Iowa) and Al Franken (D, Minn.). If passed, the bill would give the FDA authority to regulate so-called compounding manufacturers.
In May, David G. Miller, RPh, executive vice president and chief executive officer of the compounding pharmacists group, testified before the U.S. Senate Committee on Health, Education, Labor and Pensions, where he spoke on the proposed legislation. He said use of the phrase “compounding manufacturer” was confusing and would “blur the jurisdictional authority of regulators.”
“Compounding pharmacists do not manufacture drugs. They use FDA-approved drugs and ingredients from FDA-registered suppliers to render drugs in different forms or doses to meet the specific needs of patients,” Miller said.
In response to Thompson's announcement, Ball said members of Thompson's newly formed coalition were representatives from drug manufacturers whose products could be copied legally by compounders and sold at a lower price. “We understand why a group that represents pharmaceutical manufacturers might want to see limitations placed on compounding. It is important to note that pharmacy compounding has risen in popularity in part due to the shortages of medications produced by drug manufacturers.”
In his testimony to Congress, Miller said the organization advocated for proposed legislation to actively reaffirm state authority and for the FDA to report to Congress how it has handled complaints about compounded medications.