News
FDA revives compounding advisory committee
W
hen FDA in late February convened a meeting of its Pharmacy Compounding Advisory Committee, the agency essentially resumed a project that had been on hold for more than a dozen years. Part of that project involved revising FDA’s 1999 list of drugs that may not be used for compounding because they are not safe and effective. The development of the list had been shelved after a 2002 Supreme Court ruling invalidated part of the statute by which FDA regulates compounded products. According to FDA, that legal dispute was resolved in 2013 after the Drug Quality and Security Act (DQSA) was signed into law. The agency last year proposed to add 25 drugs to the do-not-compound list, and part of the February 23–24 meeting was dedicated to revamping the list. In separate votes, most of which were unanimous, the advisers recommended that the do-not-compound list be amended to include all 25 drugs, as follows: all formulations of alatrofloxacin mesylate, aminopyrine, astemizole, cerivastatin sodium, cisapride, grepafloxacin, methoxyflurane, novobiocin sodium, pemoline, pergolide mesylate, phenylpropanolamine, propoxyphene, rapacuronium bromide, rofecoxib, sibutramine hydrochloride, tegaserod maleate, troglitazone, trovafloxacin mesylate, and valdecoxib; bromfenac sodium and gatifloxacin, except for ophthalmic solutions; parenteral drug products containing esmolol hydrochloride that supply 250 mg/ mL of concentrated esmolol per 10-mL
Promotion Rebecca A. Taylor, Pharm.D., M.B.A., BCPS, has been promoted to Director of Pharmacy, Marymount Hospital, Garfield Heights, Ohio; previously she was the pharmacy manager at Marymount, which is part of the Cleveland Clinic.
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ampul; extended-release oxycodone hydrochloride formulations without abusedeterrent properties; all drug products containing polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution, and 10 mg or more of bisacodyl delayedrelease tablets; and oral formulations of chloramphenicol. The committee also agreed that a previous entry on the list, “adenosine phosphate,” refers to adenosine 5'-monophosphate, adenosine 5'-diphosphate, and adenosine 5'-triphosphate. According to FDA, the do-notcompound determination applies to facilities regulated under sections 503A and 503B of the federal Food, Drug, and Cosmetic Act. Section 503A refers to entities that perform so-called traditional compounding, and section 503B governs compounding conducted by FDA-registered compounding outsourcing facilities. The advisory committee was also charged with discussing criteria for the development of a list of bulk drug substances that may be compounded under section 503A. Drugs that may be included on the list are generally active ingredients that lack a United States Pharmacopoeia (USP) National Formulary monograph and are not components of FDA-approved drugs, explained Kalah Auchincloss, acting director of FDA’s Office of Unapproved Drugs and Labeling Compliance. FDA in 1999 had proposed criteria for inclusion on the bulk drug substances list, and the DQSA in 2013 required that the agency revive the process. By statute, FDA must consider the historical use of the bulk drug substances and peerreviewed medical literature about the substances before adding them to the list. Additional criteria proposed by FDA include an assessment of the drug’s physical and chemical characteristics and whether this information indicates that it is appropriate to use the drug in compounding. An assessment of available data about the drug’s safety and effectiveness is
Am J Health-Syst Pharm—Vol 72 Apr 15, 2015
also part of the proposed process for adding a drug to the list, although Auchincloss said safety data from studies of humans is often lacking for these substances. Jane Axelrad, associate director for policy at FDA’s drugs division, said available data about the bulk drug substances may include peer-reviewed research but probably not “adequate, well-controlled studies.” “We’ll look at anything we can find,” she noted. Axelrod also recalled that in the past, the inclusion of a drug on the list often prompted the development of a USP monograph for that substance. Of the 30 bulk drug substances FDA had identified for the list in 1999, 18 have since been the subject of a USP monograph or have become a component of an FDA-approved drug. These drugs no longer qualify for inclusion on the bulk drug substances list. As part of its DQSA implementation, FDA asked the public to nominate medications for the revamped list of bulk drug substances. ASHP nominated three drugs—diphenylcyclopropenone, squaric acid dibutyl ester, and thymol iodide. Christopher Topoleski, director of federal regulatory affairs for ASHP, said these topically applied drugs were selected because FDA had identified them in 1999, and they remain in widespread use globally. In all, FDA’s advisers voted on whether to include six nominated drugs on the bulk substances list: cantharidin, diphenylcyclopropenone, piracetam, silver protein mild, squaric acid dibutyl ester, and thymol iodide. The advisers ultimately voted in favor of placing cantharidin, diphenylcyclopropenone, squaric acid dibutyl ester, and thymol iodide on the list but not silver protein mild or piracetam. In all cases, the committee’s votes agreed with FDA’s assessment of whether or not to list the drugs. Gerald McEvoy, ASHP’s assistant vice president for drug information, presented the case to the committee for placing diphenylcyclopropenone on the bulk drug substances list.
News
McEvoy told the committee that the drug is compounded for the topical treatment of cutaneous warts and alopecia areata. He said that although ASHP could not identify “any well-designed randomized controlled clinical trials of its use for these conditions,” available data and expert opinion support the drug’s use to treat those conditions. The committee voted 9 to 1 in favor of adding the drug to the list. FDA stated that additional committee meetings are planned to help the agency modify and maintain the list. —Kate Traynor DOI 10.2146/news150030
News Briefs • DNV GL Healthcare USA Inc. is the new name for the national accrediting organization previously called Det Norske Veritas Healthcare Inc., or DNVHC. The organization’s parent company merged with Germanischer Lloyd in 2013. • Community Health Accreditation Partner Inc. is the new business name for the national accrediting organization that operates the Community Health Accreditation Program, or CHAP.
Am J Health-Syst Pharm—Vol 72 Apr 15, 2015
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Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
FDA revives compounding advisory committee
W
hen FDA in late February convened a meeting of its Pharmacy Compounding Advisory Committee, the agency essentially resumed a project that had been on hold for more than a dozen years. Part of that project involved revising FDA’s 1999 list of drugs that may not be used for compounding because they are not safe and effective. The development of the list had been shelved after a 2002 Supreme Court ruling invalidated part of the statute by which FDA regulates compounded products. According to FDA, that legal dispute was resolved in 2013 after the Drug Quality and Security Act (DQSA) was signed into law. The agency last year proposed to add 25 drugs to the do-not-compound list, and part of the February 23–24 meeting was dedicated to revamping the list. In separate votes, most of which were unanimous, the advisers recommended that the do-not-compound list be amended to include all 25 drugs, as follows: all formulations of alatrofloxacin mesylate, aminopyrine, astemizole, cerivastatin sodium, cisapride, grepafloxacin, methoxyflurane, novobiocin sodium, pemoline, pergolide mesylate, phenylpropanolamine, propoxyphene, rapacuronium bromide, rofecoxib, sibutramine hydrochloride, tegaserod maleate, troglitazone, trovafloxacin mesylate, and valdecoxib; bromfenac sodium and gatifloxacin, except for ophthalmic solutions; parenteral drug products containing esmolol hydrochloride that supply 250 mg/ mL of concentrated esmolol per 10-mL
Promotion Rebecca A. Taylor, Pharm.D., M.B.A., BCPS, has been promoted to Director of Pharmacy, Marymount Hospital, Garfield Heights, Ohio; previously she was the pharmacy manager at Marymount, which is part of the Cleveland Clinic.
598
ampul; extended-release oxycodone hydrochloride formulations without abusedeterrent properties; all drug products containing polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution, and 10 mg or more of bisacodyl delayedrelease tablets; and oral formulations of chloramphenicol. The committee also agreed that a previous entry on the list, “adenosine phosphate,” refers to adenosine 5'-monophosphate, adenosine 5'-diphosphate, and adenosine 5'-triphosphate. According to FDA, the do-notcompound determination applies to facilities regulated under sections 503A and 503B of the federal Food, Drug, and Cosmetic Act. Section 503A refers to entities that perform so-called traditional compounding, and section 503B governs compounding conducted by FDA-registered compounding outsourcing facilities. The advisory committee was also charged with discussing criteria for the development of a list of bulk drug substances that may be compounded under section 503A. Drugs that may be included on the list are generally active ingredients that lack a United States Pharmacopoeia (USP) National Formulary monograph and are not components of FDA-approved drugs, explained Kalah Auchincloss, acting director of FDA’s Office of Unapproved Drugs and Labeling Compliance. FDA in 1999 had proposed criteria for inclusion on the bulk drug substances list, and the DQSA in 2013 required that the agency revive the process. By statute, FDA must consider the historical use of the bulk drug substances and peerreviewed medical literature about the substances before adding them to the list. Additional criteria proposed by FDA include an assessment of the drug’s physical and chemical characteristics and whether this information indicates that it is appropriate to use the drug in compounding. An assessment of available data about the drug’s safety and effectiveness is
Am J Health-Syst Pharm—Vol 72 Apr 15, 2015
also part of the proposed process for adding a drug to the list, although Auchincloss said safety data from studies of humans is often lacking for these substances. Jane Axelrad, associate director for policy at FDA’s drugs division, said available data about the bulk drug substances may include peer-reviewed research but probably not “adequate, well-controlled studies.” “We’ll look at anything we can find,” she noted. Axelrod also recalled that in the past, the inclusion of a drug on the list often prompted the development of a USP monograph for that substance. Of the 30 bulk drug substances FDA had identified for the list in 1999, 18 have since been the subject of a USP monograph or have become a component of an FDA-approved drug. These drugs no longer qualify for inclusion on the bulk drug substances list. As part of its DQSA implementation, FDA asked the public to nominate medications for the revamped list of bulk drug substances. ASHP nominated three drugs—diphenylcyclopropenone, squaric acid dibutyl ester, and thymol iodide. Christopher Topoleski, director of federal regulatory affairs for ASHP, said these topically applied drugs were selected because FDA had identified them in 1999, and they remain in widespread use globally. In all, FDA’s advisers voted on whether to include six nominated drugs on the bulk substances list: cantharidin, diphenylcyclopropenone, piracetam, silver protein mild, squaric acid dibutyl ester, and thymol iodide. The advisers ultimately voted in favor of placing cantharidin, diphenylcyclopropenone, squaric acid dibutyl ester, and thymol iodide on the list but not silver protein mild or piracetam. In all cases, the committee’s votes agreed with FDA’s assessment of whether or not to list the drugs. Gerald McEvoy, ASHP’s assistant vice president for drug information, presented the case to the committee for placing diphenylcyclopropenone on the bulk drug substances list.
News
McEvoy told the committee that the drug is compounded for the topical treatment of cutaneous warts and alopecia areata. He said that although ASHP could not identify “any well-designed randomized controlled clinical trials of its use for these conditions,” available data and expert opinion support the drug’s use to treat those conditions. The committee voted 9 to 1 in favor of adding the drug to the list. FDA stated that additional committee meetings are planned to help the agency modify and maintain the list. —Kate Traynor DOI 10.2146/news150030
News Briefs • DNV GL Healthcare USA Inc. is the new name for the national accrediting organization previously called Det Norske Veritas Healthcare Inc., or DNVHC. The organization’s parent company merged with Germanischer Lloyd in 2013. • Community Health Accreditation Partner Inc. is the new business name for the national accrediting organization that operates the Community Health Accreditation Program, or CHAP.
Am J Health-Syst Pharm—Vol 72 Apr 15, 2015
599
Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
