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22-Oct-2019 04:36

A proposal on CGMP regulations the FDA regulations that set forth universities: State and foreign health- for large volume parenteral drug prod­ care organizations; domestic and for­ current good manufacturing practice ucts (LVP) for human use was pub­ (CGMP) for human and veterinary eign drug manufacturers, repackers. Production and Process Controls (paragraphs 263 to 310). Packaging and Labeling Control (paragraphs 311 to 373). Holding and Distribution (para­ graphs 374 to 379). The propos­ al was intended to solve many of these problems. vidual consumers; nonprofit institu­ would be deleted from the final regu­ ACTION: Final rule. SUMMARY: This document amends partments of hospitals, colleges, and 4. 190 - FRIDAY, SEPTEMBER 29, 1978 45015 RULES AND REGULATIONS XII. In addition, many requirements prompt­ ed questions about interpretation, vagueness, and omissions.

Com­ current technology for drug manufac­ facturers; and numerous trade and ments were due by September 29. Rice, Jr., vaged drug products appeared in the graphs 89 to 126). The period provided for public comment was 120 days instead of the usual 60 days because of the length of the pro­ posal; the novel, controversial, or com­ plex nature of some of the proposed provisions; and the desire to give af­ fected persons ample time for revlew and preparation of extensive com­ ments.

General Comments (paragraphs 1 to every comment and all suggested al­ quality and purity characteristics that 12). For the reasons set forth in the agency’s economic impact assessment, in is believed that this final regulation will not cause major economic impact, as defined by Executive Order 11821 (as amended by Executive Order 11949), and OMBCir­ cular A-107. A number of comments said the proposed CGMP regulations would impose rigid and inflexible standards that would curtail progress and dis­ courage technological innovations.

Many comments were received re­ garding the need for the proposed changes in the CGMP regulations.

That means that while drugs will be safe up to 6 years (3 years past their expiry date), they may not necessarily be as effective as they were when formulated.

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That does NOT mean that you should take more however as the decrease in effectiveness may be different for each different drug and will also depend on how it was stored (see above).

45014 RULES AND REGULATIONS SUPPLEMENTARY INFORMATION: als were reviewed and considered in In the FEDERAL REGISTER of February preparing the final regulations Set Title 21-Food and Drugs 13. That of the Federal Food, Drug, and C o s ­ proposal is the basis for the subject FARE metic Act (21 U. and rev­ quirements to assure the quality of ocation of § 229.25. These com­ garding such filters because all refer­ ments represent many interests - indi­ ences to glass fiber-containing filters tion. Briefly sum­ marizing this discussion, the techno­ logical advances and the general up­ grading of drug quality assurance by most manufacturers since the CGMP regulations were promulgated in 1983 and last updated in 1971 mean that the “current good manufacturing practice” reflected in the existing reg­ ulatlons are no longer “current” in many respects and are not suited to current manufacturing techniques.



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