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THRIFT DRUG's STABILITY TESTING ON REPACKAGED CREAMS AND OINTMENTS

Executive Summary

THRIFT DRUG's STABILITY TESTING ON REPACKAGED CREAMS AND OINTMENTS is inadequate to support the expiration dates on the products, FDA told the firm in a Nov. 15 regulatory letter. In the letter to the J.C. Penney retail drug chain, FDA cited an August inspection of Thrift's Pittsburgh repackaging operations that found the chain was using manufacturers expiration dates without adequate testing on the container and closure systems used in repackaging the products. The firm repackages the topicals principally into one-ounce jars. FDA said that Thrift has "not confirmed tentative expiration dates based on accelerated stability studies, with shelf life studies for the prescription creams and ointments." In addition, FDA noted that "products containing preservatives to inhibit microbial growth are not monitored throughout the shelf life to assure the effectiveness of your preservative system." Thrift also had not demonstrated, in lieu of stability testing, that the container-closure systems used in repackaging were equivalent to or better than the manufacturer's, FDA maintained. Thrift met with FDA on Dec. 7 to discuss a response to the issues raised in the regulatory letter and to review stability data that Thrift had not presented during the August inspection. According to Thrift, FDA was satisfied with the firm's response, pending a follow-up inspection by FDA. One factor in FDA's decision to issue the regulatory letter may have been Thrift's failure to formally respond to the FD-483 adverse findings report on the inspection. In a Nov. 23 written response to the FDA letter, Thrift informed the agency that it had submitted samples of products repackaged over the past two years to Scientific Associate Laboratories and that the results of the lab's testing "have all been positive and are now on file." Thrift also said that these test results, as well as previous stability studies run by the outside lab, "demonstrate the viability of our container-closure system." In addition, Thrift said that samples of each of the creams and ointments will continue to be submitted on a yearly basis to the lab, and "will further demonstrate our container-closure system meets or surpasses that of the manufacturer." Other adverse CGMP findings from FDA's August inspection involved a lack of written specifications for caps and liners, employee CGMP training, and investigation into yield discrepancies, according to the FDA letter. Thrift Drugs' review procedures for incoming packaging and labeling materials were also named in the letter. For instance, the agency noted that Thrift's labels for Nolamine and Westcort Cream "were not consistent with the ingredients and cautions on the manufacturer's label for these two products." Thrift's quality control unit had also failed to sign-off on packaging and labeling production and control records prior to batch release, the letter maintains.
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