关于药品（比如冻干粉）reconstitution后的有效期规定

beiwei5du

各位蒲友：


针对于国内的冻干药品（和其他需要进行临用前配制的药品，比如浓溶液）大家是否除了规定相应的reconstitution前的药品有效期外，是否有要求规定reconstitution后的有效期呢？？请知晓人事指导一下，非常感谢。
我有了解FDA是有这方面的要求的（请看下文和下图）


§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, 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（排除在211.137外）.
(f) Allergenic extracts that are labeled “No U.S. Standard of Potency” are exempt from the requirements of this section（排除在211.137外）.
(g) New drug products for investigational use are exempt from the requirements of this section, provided that they meet appropriate standards or specifications as demonstrated by stability studies during their use in clinical investigations. （排除在211.137外）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（对于临床用药的需要reconstitution的药品也需要注意标识相应的expiration information for the reconstituted drug product）.
(h) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978,(部分的豁免情况） 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.（排除在211.137外）

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

reference:http://www.cwladis.com/math104/lecture4.php

             http://www.austincc.edu/rxsucces/pdf/reconstructionpdf.pdf

蓝雨~

看看，英语渣渣

王雪1993

学习了，谢谢

大龙12

辛苦！感谢！

小金库

学习一下，谢谢分享