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Executive Summary

REPACKAGED ORAL SOLID DRUG PRODUCTS EXPIRATION DATING does not require additional stability testing if the equivalency of packaging materials has been established, a Center for Drug Evaluation and Research draft guideline on manufacturing and control requirements for repackaging states. The recently-issued guideline explains that a repacker may use the manufacturer's original expiration date without additional stability testing "if the drug product is repackaged into an equivalent container- closure system that is at least as protective or more protective than the original system." System equivalency, FDA explains, should extend to "any special protective materials, such as light transmission, seals or dessicants associated with the original container-closure system in which the drug product is marketed." Various methods may be used to establish the container-closure comparability, the guideline states, including referencing of studies performed by other firms. However, these studies "must directly pertain to the container-closure system used for the specific drug product in question, and documentation must be kept on file by the repackager." The repackaging guideline focuses on those areas of the current good manufacturing practice regulations (CGMPs) about which the agency most frequently has been questioned by firms engaged in repackaging operations. According to the guideline, repackers have expressed confusion about how the CGMPs apply depending on the type of repackaging operation, the specific dosage form being repackaged and the type of packaging materials involved. FDA investigators, in turn, have found significant GMP violations recently at a number of repackaging facilities. In several cases, extensive recalls and/or enforcement actions against the firms have resulted. Included in the CDER document is a discussion of specific requirements for expiration dating of products repackaged into unit-dose and unit-of-use containers. Along with stability studies and expiration dating, the guideline also addresses product testing/examination, labeling control, reserve samples and penicillin cross-contamination for repackaging operations. The regulatory requirements in these areas are discussed by CDER along with practices and procedures that may be used to comply with the regulations. The guideline applies only to the repackaging of solid oral dosage forms with approved NDAs or ANDAs. FDA requires premarket approval for repackaging of any other new drug dosage forms, including liquids, creams and ointments, even though the manufacturer holds an approved application. The repackaging guideline is part of an FDA effort to better regulate the downstream handling/manipulation of drug products. Earlier this year, FDA issued a "compliance policy guide" specifying parameters for acceptable pharmacy compounding within the new drug and GMP regulations ("The Pink Sheet" March 23, p. 8). FDA notes in the repackaging guideline that the CGMP requirements applicable to repackers do not apply to pharmacists filling prescriptions for identified patients. However, they do apply "to pharmacists, or any other entities that repackage drugs for distribution, which is beyond the regular practice of pharmacy, e.g., for resale or distribution to hospitals or other pharmacies." CDER is asking for industry input on the draft repackaging guideline. Comments should be submitted to FDA's Dockets Management Branch, 12420 Parklawn Dr., Rockville, Md. 20857 by Dec. 14.

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