Idaho Admin. Code r. 24.36.01.406 - LABELING STANDARDS

All prescription drugs must be in an appropriate container and bear information that identifies the drug product, any additional components as appropriate, and the individual responsible for its final preparation.

01. Standard Prescription Drug. A prescription drug for outpatient dispensing must be labeled in accordance with federal law.

02. Parenteral Admixture. If one (1) or more drugs are added to a parenteral admixture, the admixture's container must include the date and time of the addition, or alternatively, the beyond use date.

03. Prepackaged Product. The containers of prepackaged drugs must include an expiration date that is the lesser of the manufacturer's original expiration date, one (1) year from the date the drug is prepackaged, or a shorter period if warranted.

04. Repackaged Drug. If a previously dispensed drug is repackaged, it must contain the serial number and contact information for the original dispensing pharmacy, as well as a statement that indicates that the drug has been repackaged, and the contact information of the repackaging pharmacy.

05. Distributed Compounded Drug Product. Compounded and sterile prepackaged drug product distributed in the absence of a patient specific prescription must be labeled as follows:

a. If from a pharmacy, the statement: "not for further dispensing or distribution."

b. If from an outsourcing facility, the statements: "office use only" and "not for resale."

Notes

Idaho Admin. Code r. 24.36.01.406

Effective March 28, 2023