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.
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.
issued under section 501(a)(2)(B) February 13, 1976 (41 FR 6878). 207.3, SUBCHAPTER C-DRUGS: GENERAL nology and to adopt more specific re 207.20, and Parts 210 and 211. Current Good Manufacturing Practice until June 14, 1976, for interested per ulations) by eliminating reference to in Manufacture, Processing, Pack- sons to submit comments. It, therefore, elimi The Commissioner received com nated the need for further comments Ing, or Holding ments from 168 respondents totaling on the February 13, 1976, proposal re AGENCY: Food and Drug Administra approximately 2,000 pages. The need and rationale for an over all revision and for specific changes in the CGMP regulations are discussed at length in the preamble to the Feb ruary 13, 1976 proposal.
The agency has received numerous inquir ies requesting clarification of certain provisions, and it sought to remove ambiguities by this revislon.
In finaliz lng these revisions, the Commissioner has considered past.
Note also that I stated that the effectiveness (and safety) is from the date the drug was formulated, not the date that you purchased it.
That’s because there may be a delay between when the drug was made before it was sold to a drug wholesaler, who then had it on their shelf for a while before it was purchased by a pharmacy who in turn may have had it on their shelf for a while before being dispensed to the patient (you).
1976 turing and delineate requirements professional associations representing and are under review. (HFD-30) (301-443-5220), Bureau of FEDERAL REGISTER of January 16, 1975 IX. Drugs, Food and Drug Administra (40 FR 2822) and was reproposed as 127 X. tion, Department of Health, Educa § 211.208 (21 CFR 211.208) in the FEDXI. Having reviewed the preamble of the February 13, 1978, proposal and the extensive comments, the Commission er is satisfied that an updating of the CGMP regulations is necessary and desirable.
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.
The amendments and distributors; consultants to the June 1. The pro update present regulations in light of drug industry; drug equipment manu posal would add a new Part 212. and to submit reasoned comments with suggested alternative language.
accordance with instructions appearing at 12 CFR ... l i s h e d in the F EDERAL REGISTER of drug products. Interested persons were urged to revlew the proposal carefully, to identify any areas that might re quire clarification or modlflcatton.
A proposal on CGMP regulations sioner of Food and Drugs proposed to CHAPTER I-FOOD AND DRUG AD revise the CGMP regulations, Parts for human and veterinary drugs ap MINISTRATION DEPARTMENT OF 210 and 211 (21 CFR Parts 210 and peared in the FEDERAL REGISTER of HEALTH, EDUCATION, AND WEL 211). to final regulations and included pro update them in light of current tech posed revisions in § § 201.17. A final regulation in the FEDERAL HUMAN AND VETERINARY DRUGS nature and extent of the proposed re REGISTER of April 23, 1978 (41 FR visions, the Commissioner allowed 16932) amended Part 211 (CGMP reg. Returned and Salvaged Drug Prod ucts (paragraphs 501 to 517). CGMP for Certain Other Drug Products (paragraph 518). A number of comments from individual consumers, a State consumer services organization, and a national associ ation of health-care professionals strongly fuvored new or revised regula tions that would improve the level of assurance that marketed drug prod ucts meet hlgh quality standards, Many other comments, particularly from manufacturers and trade associ ations, generally supported the desir ability of CGMP regulations, but ob jected to specific provisions of the pro posal and questioned whether a favor able cost-benefit ratio justified imple menting some of the proposed provi sions. par ticularly smaller firms, objected to the proposed changes, maintaining that drug quality would not be improved by the proposed changes and that the costs outweigh any benefits.