(b) expiration dates shall be related to any storage conditions stated on the labeling, as determined by stability studies described in 211166 (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.
(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 211166.
Drugs, including those that are both drugs and cosmetics, must be tested for stability (see the regulations at 21 cfr 211) and are required to have expiration dates printed on the labels. The draft guideline expiration dating of unit-dose repackaged solid oral dosage form drug products was announced on august 8, 2017, and replaces the draft guidance for industry expiration dating of unit-dose repackaged drugs: compliance policy guide (2005. The absence of an expiration date on any drug product packaged after september 29, 1979, except for those drugs specifically exempt by 211137 (e), (f), and (g), is cause to initiate regulatory. Fda's current good manufacturing practice (cgmp) regulations for finished pharmaceuticals require that each drug product bear an expiration date determined by appropriate stability testing and that the date must be related to any storage conditions stated on the labeling, as determined by stability studies (21 cfr 211137(a) and (b).
Under § 211137(b), a drug product’s expiration date must be related to any storage conditions stated on the labeling, as determined by stability studies described in § 211166. Where more than one drug product lot with different manufacture dates are packaged together (eg 1, 2, 4, 8mg of a product blistered and sealed into one card), the expiration date of the complete package must not exceed that of the product lot with the shortest remaining expiration period used in the package.
Regulations pertaining to expiration dating of drug products posted on 18022018 by kajilar posted in fat — 1 comments ⇩ the manufacturer should include, in the package insert or in other appropriate literature supplied to the repackager, the following information about the packaging: cookies help us in providing our services. Fda current good manufacturing practice regulations stipulate that for finished pharmaceuticals, each drug product is required to bear an expiration date determined by appropriate stability testing and that the date must be related to storage conditions stated on the label, the agency says.
Federal regulations require a use-by date on the product label of infant formula under inspection of the us food and drug administration (fda) consumption by this date ensures the formula contains not less than the quantity of each nutrient as described on the label.
The fda's cgmp regulations require that each drug product bear an expiration date based on stability testing and labeled storage conditions (21 cfr § 211137(a) and (b).