Ex piration dating antibiotics

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.

Comments are be desirable- requirements for their visions for expiration dating of phar­ being reviewed, and a specific proposal maceuticals. Drug, and The comments and recommenda­ Cosmetic Act, a drug is deemed to be posed revisions, but objected to others. 1975 adulterated unless the methods used A few manufacturers objected to most and February 13, 1976 proposals, the in its manufacture, processing. and holding, and the facilities and controls used therefor, conform to cur­ that where differences existed, many proposal, and the Commissioner’s con­ rent good manufacturing practice so interested persons furnished alterna­ clusions concerning them are set out that the drug meets the safety re­ tive wording and justification in sup- below. Amendments Regarding Placement of more explicit, and therefore less sub­ ject to varylng interpretations, to other recommendatlons, not adopted Expiration Date on Drug Product Labels at this time, may be considered in any (paragraphs 19 to 27). Legal Status of CGMP Regulations EFFECTIVE DATE: March 28.1979. Modifica­ tions were adopted, or decisions were made not to finalize particular aspects of the proposal, in order to add flexi­ bility for manufacturers, to relieve or eliminate unjustified cost burdens, or to clarify the requirements, without adversely affecting the best interests of the consumer.

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.

It may not (but probably does) apply to drugs made in different countries under different regulations.

Consumers, in particu­ tended to October 29, 1976 by notice in it in the regulations or are at least lar, expressed strong support for the FEDERAL REGISTER of September considered by most manufacturers to proposed revisions, especially the pro­ the 10, 1976 (41 FR 38540). facturers agreed with many of the pro­ Under the Federal Food. 1976 amendment to the latter The Commissioner is pleased to note ing. The Commissioner is promulgating those regulations em­ bodying contemporary practices that will maintain or improve the quality of pharmaceuticals without imposing un­ reasonable or excessive costs or other burdens on manufacturers.

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(There are a few drugs that have a shorter expiry date but that doesn’t apply in the case of Tylenol ®)When every batch of drugs is made a certain number of samples must be retained and tested on a set schedule up to the 6 year mark to confirm that that batch of drugs is still safe.

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