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21 CFR 211.137 - Expiration dating.

- Code of Federal Regulations - Title 21: Food and Drugs - Subpart G: Packaging and Labeling Control - Id 19708323 - vLex Acceso clientes Ayuda Capacitacin

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21 CFR 211.137 - Expiration dating.


Code of Federal Regulations - Title 21: Food and Drugs Actualizado a: 1 de Abril de 2011

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Title 21: Food and Drugs CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) SUBCHAPTER C: DRUGS: GENERAL PART 211: CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart G: Packaging and Labeling Control 211.137 - Expiration dating. (a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in ? 211.166. (b) Expiration dates shall be related to any storage conditions stated on the labeling,
http://cfr.vlex.com/vid/211-137-expiration-dating-19708323[16/09/2012 10:05:37 p.m.]

21 CFR 211.137 - Expiration dating. - Code of Federal Regulations - Title 21: Food and Drugs - Subpart G: Packaging and Labeling Control - Id 19708323 - vLex

as determined by stability studies described in ? 211.166. (c) If the drug product is to be reconstituted at the time of dispensing, its labeling shall bear expiration information for both the reconstituted and unreconstituted drug products.

(d) Expiration dates shall appear on labeling in accordance with the requirements of ? 201.17 of this chapter.

(e) Homeopathic drug products shall be exempt from the requirements of this section. (f) Allergenic extracts that are labeled ?No U.S. Standard of Potency? are exempt from the requirements of this section. (g) New drug products for investigational use are exempt from the requirements of this section, provided that they meet appropriate standards or specifications as

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demonstrated by stability studies during their use in clinical investigations. Where new drug products for investigational use are to be reconstituted at the time of dispensing, their labeling shall bear expiration information for the reconstituted drug product. (h) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this section shall not be enforced for human OTC drug products if their labeling does not bear dosage limitations and they are stable for at least 3 years as supported by appropriate stability data.

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[43 FR 45077, Sept. 29, 1978, as amended at 46 FR 56412, Nov. 17, 1981; 60 FR 4091, Jan. 20, 1995]

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http://cfr.vlex.com/vid/211-137-expiration-dating-19708323[16/09/2012 10:05:37 p.m.]

21 CFR 211.137 - Expiration dating. - Code of Federal Regulations - Title 21: Food and Drugs - Subpart G: Packaging and Labeling Control - Id 19708323 - vLex

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