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Drug Product Compounding Issues Addressed by FDA Panel

Wednesday, February 25, 2015   (0 Comments)
Posted by: Dagmar Anderson
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FDA's Pharmacy Compounding Advisory Committee voted to add 25 drugs to the list of drug products that may not be compounded under the exemptions provided by the Federal Food, Drug, and Cosmetic Act because they have been withdrawn or removed from the market as a result of their components having been determined to be unsafe or ineffective. "The agency continually evaluates the safety of drug products, and [the Center for Drug Evaluation and Research's (CDER's)] ongoing commitment to rigorous and continued drug safety evaluation in the postmarket period is reflected in its Safety First initiative, which was launched in 2008 and which outlines CDER's updated policies and procedures to ensure that equal focus and equal attention is given to postmarket drug safety as is given during premarket drug review," said Mwango A. Kashoki, MD, MPH, associate director for Safety, Office of New Drugs, Immediate Office, CDER, FDA. The committee also discussed proposed criteria for developing the list of bulk drug substances that may be used to compound drug products.


The committee voted unanimously to add 24 drugs to the list of drugs that may not be compounded: all drug products containing alatrofloxacin mesylate, aminopyrine, astemizole, bromfenac sodium (except ophthalmic solutions), cerivastatin sodium, cisapride, all parenteral drug products containing esmolol HCl that supply 250 mg/mL of concentrated esmolol per 10-mL ampule, gatifloxacin (except ophthalmic solutions), grepafloxacin, methoxyflurane, novobiocin sodium, pemoline, pergolide mesylate, phenylpropanolamine, propoxyphene, rapacuronium bromide, rofecoxib, sibutramine hydrochloride, tegaserod maleate, troglitazone, trovafloxacin mesylate, valdecoxib, all extended-release drug products containing oxycodone hydrochloride that have not been determined by the FDA to have abuse-deterrent 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 delayed-release tablet.

The committee also voted 11 to 1 in favor of adding all drug products containing etretinate to the list.

The committee voted unanimously to update the current entry of "Adenosine phosphate: All drug products containing adenosine phosphate" to state, "All drug products containing adenosine 5'-monophosphate (AMP), adenosine 5'-diphosphate (ADP), and adenosine 5'-triphosphate (ATP)."

The committee voted 9 to 2 (1 no-vote) in favor of adding all oral drug products containing chloramphenicol to the list.

Chloramphenicol for injection is approved by the FDA and is still marketed in the United States. It has a boxed warning because of an increased risk for serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia). Aplastic anemia that later terminated in leukemia has also been attributed to chloramphenicol for injection. Published literature suggests the risk for aplastic anemia is higher with the oral formulation.

Other less toxic and more efficacious antibacterial drugs are available.


The bulk drug substances list is a list of bulk drug substances that may be used to compound drug products according to section 503A of the Federal Food, Drug, and Cosmetic Act, even though they are neither the subject of a United States Pharmacopeia or National Formulary monograph nor components of drugs approved by the FDA.


Medscape (02/24/15) Brown, Troy


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