059-13 Wyo. Code R. §§ 13-2 - Definitions

(a) "Active Ingredient" means an ingredient added to a compounded prescription product that provides the therapeutic effect desired from the compounded prescription product. This does not include "inert" ingredients.

(b) "Beyond-use Date (BUD)" means a date after which a compounded product should not be used.

(c) "Component" means any ingredient used in the compounding of a drug product, including those ingredients that may not appear in the labeling of such product.

(d) "Compounding" means and includes the preparation, mixing, or assembling of a drug or device, and the packaging and labeling incident thereto for sale or dispensing:

(i) as the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of his/her professional practice.

(ii) for the purpose of research, teaching, or chemical analysis, or

(iii) in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

However, "compounding" does not include mixing or reconstituting of non-sterile products performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.

(e) "Manufacturing" means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of the substance(s) or labeling or re-labeling of its container, and the promotion and marketing of such drugs or devices. Manufacturing also includes any preparation of a drug or device that is sold for resale by pharmacies, practitioners, or other persons.

(f) "Master Compounding Record" means an established record of all compounded products from the time of initial compounding that can be followed each time that compound is prepared in the future.

(g) "Stability" means the extent to which a compounded product retains, within specified limits and throughout its period of both storage and use, the same properties and characteristics it possessed at the time of preparation.

Notes

059-13 Wyo. Code R. §§ 13-2