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FDA COMPOUNDING ENFORCEMENT POLICY MAY ISSUE AS SOON AS WEEK OF MARCH 16, AGENCY’s RHEINSTEIN TELLS ASCP; APhA RELEASES SURVEY ON PATIENT COUNSELING

Executive Summary

FDA is close to completing an enforcement policy on compounding and may issue a guidance document "as early as" the week of March 16-20, the agency's Health Affairs Office Medical Staff Director Peter Rheinstein, MD, told a March 10 session of the American Society of Consultant Pharmacists legislative and regulatory affairs conference in Washington, D.C. "The agency hopes to have a compliance policy guide ready in the very near future" to advise its field force on how to enforce consistently FDA's policy on compounding, Rheinstein said. One possible forum for issuance of the policy is the American Pharmaceutical Association's annual meeting. FDA Commissioner Kessler is slated to address the meeting on March 16 about the interaction of the agency and pharmacy in patient healthcare and the role of the pharmacist in patient education. Rheinstein emphasized to ASCP that "the agency does not intend to deny pharmacists the right to compound and manipulate extemporaneously reasonable quantities of drugs pursuant to a prescription" order. "FDA will, however, try to stop...so-called compounding, where the compounding amounts to large-scale manufacturing," Rheinstein asserted. "FDA is taking this action because a growing number of establishments are using a retail pharmacy license to manufacture, distribute [to other retailers and health care providers] and promote on a commercial scale." Such establishments "have their own detail persons, marketing consultants [and] promotion departments; they operate like manufacturers and wholesalers but without the stringent safety and quality controls of legitimate pharmaceutical companies," he maintained. "One of these establishments produced over 300,000 dosage units of albuterol sulfate and other inhalation therapy drugs for 6,000 patients," he said. "Another company had enough bulk ingredients on hand to manufacture 165 different products. All of this has gone on under the guise of compounding." Rheinstein noted that FDA became concerned about the issue in early 1991 after "an outbreak of eye infections during which two patients lost their eyesight" due to nonsterile eyedrops produced by a pharmacy "on a large scale without following proper procedure." In developing its policy guide on compounding, FDA has consulted with the National Association of Boards of Pharmacy ("The Pink Sheet" Feb. 17, p. 17). The association recommended that, in addition to the volume of an operation and promotional activities, the preparation of products already commercially available often betrays an operation to be manufacturing rather than compounding. At its March 14-18 annual meeting in San Diego, APhA will consider a policy resolution asserting that compounding "is an essential part of" pharmacy practice. APhA's Policy Committee on Professional Affairs urged the association to establish a working group to develop recommendations on several related issues, including the appropriate role of regulatory agencies in setting limits on pharmacy practice and "challenges to the right to compound." The committee said challenges to pharmacy compounding are "exemplified" by Rogaine-manufacturer Upjohn's pursuit of litigation against pharmacists who compound minoxidil tablets into topical solutions for treatment of hair loss. Policy committee recommendations are reviewed by APhA's reference committees during the annual meeting before being referred to the association's House of Delegates, which vote on whether to adopt them as official policy (see related story, T&G-11).
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