Nevada Administrative Code
Chapter 639 - Pharmacists and Pharmacy
COMPOUNDING AND DISPENSING DRUG PRODUCTS
Standards for Compounding and Dispensing Sterile Products
Section 639.67061 - Low-risk sterile compounding: Process and storage

(1) The compounding process involves aseptic manipulations that are performed entirely within an environment with an air quality of at least ISO Class 5 and uses only sterile ingredients, products, components and devices;

(2) The compounding process involves only transferring, measuring and mixing manipulations and uses not more than three commercially manufactured sterile drug products or other entries of a sterile drug product into one container, including, without limitation, a bag or vial, to make the final compounded drug product;

(3) The manipulations needed to compound the drug product are limited to aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers or other sterile drug products and containers for storage and dispensing;

(4) The final compounded drug product contains a volume of 15 milliliters or less of a radiopharmaceutical and has an expiration time of 18 hours or less per dosage unit, including, without limitation, a dosage unit of a radiopharmaceutical prepared from an eluate by using a molybdenum-99technetiym-99m generator; or

(5) The final compounded drug product contains commercially manufactured cyclotron radiopharmaceuticals which contain preservatives and which have expiration times of 72 hours or less.