465.0255 Expiration date of medicinal drugs; display; related use and storage instructions.
465.0255 Expiration date of medicinal drugs; display; related use and storage instructions.
(1) The manufacturer, repackager, or other distributor of any medicinal drug shall display the expiration date of each drug in a readable fashion on the container and on its packaging. The term “readable” means conspicuous and bold.
(2) Each pharmacist for a community pharmacy dispensing medicinal drugs and each practitioner dispensing medicinal drugs on an outpatient basis shall display on the outside of the container of each medicinal drug dispensed, or in other written form delivered to the purchaser:
(a) The expiration date when provided by the manufacturer, repackager, or other distributor of the drug; or
(b) An earlier beyond-use date for expiration, which may be up to 1 year after the date of dispensing.
The dispensing pharmacist or practitioner must provide information concerning the expiration date to the purchaser upon request and must provide appropriate instructions regarding the proper use and storage of the drug.
(3) This section does not impose liability on the dispensing pharmacist or practitioner for damages related to, or caused by, a medicinal drug that loses its effectiveness prior to the expiration date displayed by the dispensing pharmacist or practitioner.
(4) The provisions of this section are intended to notify the patient receiving a medicinal drug of the information required by this section, and the dispensing pharmacist or practitioner shall not be liable for the patient’s failure to heed such notice or to follow the instructions for storage.
History. ss. 1, 2, ch. 93-44; s. 8, ch. 2004-387.