059-13 Wyo. Code R. § 13-7

Current through April 27, 2019

Section 13-7 - Compounding Controls

(a) A Master Compounding Record shall be established for each newly compounded item and followed thereafter to monitor the output and to validate the performance of those compounding processes. The Master Compounding Record shall contain:

(i) Official compound name, strength, and dosage form,

(ii) Calculations required to complete the compound,

(iii) Ingredient(s) description and amounts,

(iv) Compatibility and stability information (references when available)

(v) Equipment required to prepare the compound,

(vi) Mixing instructions,

(vii) Any other factors pertinent to the compound preparation,

(viii) A sample label meeting all legal requirements stated in Chapter 2,

(ix) The generic name, quantity and/or concentration of every active ingredient containedwithin, and

(x) An assigned BUD as applicable.

(b) Components for compounding shall be accurately weighed, measured, or subdivided as appropriate. If a component is transferred from the original container to a new container, the new container shall be labeled with the same information as the original container and the date of transfer.

(c) Written control procedures shall be established to monitor the output and to validate the performance of those compounding processes that may be responsible for causing variability in the final drug product. Such control procedures shall include, but are not limited to, the following (where appropriate):

(i) Capsule weight variation;

(ii) Adequacy of mixing to insure uniformity and homogeneity; and

(iii) Clarity, completeness, or pH of solutions.

(d) At the time of dispensing to the patient, the pharmacist shall advise the patient on the proper storage, use, and anticipated shelf life of the compounded prescription product.

059-13 Wyo. Code R. § 13-7