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ALBUTEROL COMPOUNDING WARNING LETTER FROM FDA TO MISSISSIPPI OPERATION

Executive Summary

ALBUTEROL COMPOUNDING WARNING LETTER FROM FDA TO MISSISSIPPI OPERATION, dated Oct. 20, is at least the fifth letter this year from the agency complaining about alleged pharmacy violations of FD&C Act regulations. The most recent warning letter challenges Southern Healthcare Consultants, Columbus, Miss., for acting as a supplier of albuterol sulfate to pharmacies nationwide for compounding. FDA told the Mississippi firm that it could not supply pharmacies with ingredients that would be used in the compounding of a drug without an approved NDA. FDA pointed out to Southern Healthcare that "a drug prepared, packaged and primarily sold as a prescription chemical or other component for use by a registered pharmacist in compounding prescriptions or for dispensing in dosage unit form is not exempt from the misbranding provisions of [the FD&C Act] if the compounded preparations result in new drugs...and no New Drug Applications have been approved for these drugs." Southern Healthcare Consultants also is repackaging albuterol sulfate "in violation of Good Manufacturing Practices," FDA alleged. Consequently, the agency said, the product "is not assured to meet applicable standards of strength, quality and purity." Southern Healthcare said it is preparing a response to FDA's objections; the company indicated it will conduct stability tests as suggested by the agency. A previous supply warning letter in the compounding area was issued by FDA in July to Medisca, Inc., of Rouses Point, N.Y. FDA has been less active this year in enforcing the distinction between legitimate pharmacy compounding and actions which it believes represent de facto manufacturing by pharmacies. The number of warning letters emanating from FDA on the subject has dropped from at least 16 in 1992 to five in the first 10 months of this year. A policy guidance from the agency in March 1992 describing the parameters for nonviolative compounding practices has cut back the number of potential violations. The guidance plus the agency's tough enforcement attitude apparently has caused some pharmacies to halt compounding activities. Although the policy guidance has had a noticeable effect in the frequency of regulatory activities in the compounding area, FDA's authority in the field is still being challenged. One group of compounding pharmacies, doctors and individuals, calling itself P2C2, has a suit pending in Houston federal court to overturn FDA's policy guidance. The Houston suit claims that the guide was illegally promulgated because it did not go through notice-and-comment rulemaking. FDA moved to dismiss the case on the grounds that the document is a guidance and not a binding rule. The judge denied that motion; a bench trial was conducted in October. A decision is expected as early as the end of November. Among the other compounding warning letters this year, one was issued in January to Hughes Pharmacy, of Midlothian, Va., for compounding allergen patch tests without biological licenses and soliciting orders for the products. Two warning letters were sent to Iowa operations on Aug. 19: Pharmacy Associates of Marshalltown, Iowa; and Carroll Apothecary of Carroll, Iowa. The letters followed FDA inspections of their facilities. In the letters, FDA alleges that the pharmacies have been involved in "violative activities" that fall outside the bounds of "the traditional practice of pharmacy." The violative activities include "manufacturing batches of drug, and in inordinate amounts, prior to receipt of prescriptions, and keeping these manufactured products on shelves as part of your firm's normal inventory," the letter to Pharmacy Associates claims. The pharmacies also have been engaged in "compounding, regularly, drug products that are commercially available in the marketplace, and that essentially are generic copies of commercially available, FDA approved drug products," the warning letter to Carroll Apothecary says. The Iowa pharmacies were also charged with manufacturing albuterol sulfate products. FDA determined that products manufactured by Pharmacy Associates, including albuterol sulfate inhalation solution, metaproterenol inhalation solution and piroxicam capsules, are in volation of the Act because they are "new drugs without approved New Drug Applications (NDAs)." Similarly, FDA cited Carroll Apothecary for violative compounding of drugs, including albuterol sulfate, metaproterenol sulfate, terbutaline, cromolyn sodium, triamcinolone, and products containing atropine sulfate and sucralfate. Referring to an April 13 letter from the firm's VP of professional development, the warning letter to Pharmacy Associates notes: "We do not agree as stated in that letter that your firm's operations are confined to the practice of pharmacy. Nor was information available during the inspection to support [the firm's] statement that commercially available drug formulations are not manufactured unless there is a patient- specific reason." In another area of pharmacy enforcement by FDA, the agency has issued one warning letter this year alleging a violation of the Prescription Drug Marketing Act. An Oct. 27 warning letter cites Duncan Drugs, a pharmacy in Augusta, Ga., for "selling prescription drug samples to the public." Sale of drug samples is a violation of PDMA. "In July 1992, you dispensed drug samples to fill the prescription of an undercover FDA investigator. Fifteen of 30 Vasotec tablets dispensed were identified as as "SAMPLE,'" FDA stated.
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