Section 13.11. Storage requirements.

 

(1)  All prescription drugs stored in a facility shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such products, or with requirements in the current edition of an official compendium.

(2)  If no storage requirements are established for a prescription drug, the product may be held at a controlled room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(3)  Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, or logs shall be utilized to document proper storage of prescription drugs.

(4)  The recordkeeping requirements in s. Phar 13.14 shall be followed for all stored drugs.

History: Cr. Register, July, 1992, No. 439 , eff. 8-1-92; EmR0815 : emerg. am. eff. 6-1-08; CR 08-051 : am. Register November 2008 No. 635 , eff. 12-1-08.