059-17 Wyo. Code R. §§ 17-13 - Immediate Use CSPs

(a) Compounding of CSPs by pharmacy staff outside of a classified area or SCA for direct and immediate administration to patients is not subject to the requirements of this Chapter, when all of the following conditions are met:

(i) Aseptic processes are followed and written procedures are in place to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, and mix-ups with other conventionally manufactured products or CSPs;

(ii) Compounding is performed in accordance with the evidence-based information for physical and chemical compatibility of the drugs;

(iii) The preparation involves not more than three (3) different sterile products;

(iv) Any unused starting component from a single-dose container shall be discarded after preparation for the individual patient is complete. Single-dose containers shall not be used for more than one (1) patient;

(v) Administration of the CSP begins within four (4) hours following the start of preparation. If administration has not begun within four (4) hours following the start of preparations, it shall be promptly, appropriately, and safely discarded; and

(vi) Unless the CSP is administered by the person who prepared the CSP or administration is witnessed by the preparer, the CSP shall be labeled with the names and amounts of all active ingredients, the name or initials of the person who prepared the CSP, and the exact four (4) hour time period within the administration shall begin.

(b) Immediate use CSPs shall not be prepared:

(i) For medium-risk level or high-risk level CSPs;

(ii) In advance for anticipated needs; or

(iii) For batch compounding.

(c) Situations for which the immediate use CSPs can be administered include, but are not limited to:

(i) Cardiopulmonary resuscitation;

(ii) Emergency room treatment;

(iii) Preparation of diagnostic agents, or

(iv) Critical therapy where preparation under conditions for low-risk level CSPs causes delays that subject the patient to additional risk.

Notes

059-17 Wyo. Code R. §§ 17-13

Adopted, Eff. 5/13/2021.