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BLOCK DRUG's CELLOPHANE WRAP PROVIDES INADEQUATE TAMPER RESISTANCE

Executive Summary

BLOCK DRUG's CELLOPHANE WRAP PROVIDES INADEQUATE TAMPER RESISTANCE for its BC Analgesic Powders, FDA told the firm in a regulatory letter issued November 4. The letter alleges that "the tamper-resistant feature of these packages, i.e., the outer cellophane wrap with 'BC'-marked tear tape, can be opened and resealed without evidence of tampering." Consequently, FDA told Block, the products' tamper resistant statements that appear on the packaging "are false and misleading in that they represent and suggest that such packages are tamper-resistant and that they will exhibit evidence of entry if the tamper resistant feature is breached, when in fact they are not so packaged." The Block products carry the statement -- "tamper resistant package -- do not purchase if cellophone with BC-marked tear tape is torn or missing," on an immediate container; and -- "contains tamper resistant packages," on an outer carton. The regulatory letter was issued by the agency following FDA sampling of the product during a routine surveillance inspection of Block's Memphis, Tennessee manufacturing facilities. According to the letter, samples were also taken from an unrelated wholesaler. FDA has made it coear that it is committed to ensuring that TRP standards are being met. "We expect vigorous compliance with the tamper resistant packaging regulation," FDA Compliance Office Director Daniel Michels told a recent Proprietary Association (P-A) meeting, "and you can also expect vigorous enforcement." Michels told the proprietary manufacturers to expect "greater attention on the part of our field investigators to tamper resistant packaging as part of their routine surveillance inspections." The compliance director said that increased attention would be given to the TRP labeling being employed and "the use of unique identifying characteristics" as required. Michels also advised that visiting FDA investigators "may be asking what particular form of control techniques . . . you may employ to assure yourself that your TRP technology is properly" executed. Michels noted to the P-A group that cellophane overwraps with glued end flaps would be deleted in a forthcoming update of the agency's list of acceptable TRP technologies. Glued cartons would also be deleted, Michels said, and a statement included that wet shrink seals are not acceptable. At least three firms have faced product recalls over the last six months as a result of problems related to tamper-resistant packaging. According to FDA's official recall list, New Jersey-based Gendex recalled 135,936 bottles of the firm's brand of children's chewable aspirin for lacking the tamper security seals identified on the label ("The Pink Sheet" October 13, T&G-11). A recall involving 147,636 bottles of antiseptic mouthwash was issued by the Dr. G.H. Tichenor Antiseptic Company (New Orleans, Louisiana) for inadequate tamper resistant labeling ("The Pink Sheet" August 18, T&G-8). Vale Chemical (Allentown, Pennsylvania) recalled a variety of OTC tablets which, according to the FDA recall list, failed to meet tamper-resistant packaging requirements ("The Pink Sheet" July 28, T&G-9). Lack of tamper-resistant packaging was one of the reasons given by FDA for filing an August 4 seizure action against South Norwalk, Connecticut-based Ecometrics for misbranding of the firm's Serabrina Liquid ("The Pink Sheet" Sept. 8, T&G-8).
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