Section 4729:7-2-02 - Sterile compounding exemptionsThe following sterile drug compounding is exempted from the requirements of this chapter:
Preparation of a non-hazardous, conventionally manufactured sterile products in accordance with the directions contained in approved labeling provided by the product's manufacturer if preparation complies with all the following: (A) Administration of the drug product must begin within one hour of beginning the preparation (e.g., within one hour of initial entry into or puncture of a singledose container).(B) Aseptic technique must be followed. Procedures must be in place to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, and mix-ups with other products or compounded sterile preparations.(C) A pharmacist or prescriber performs the final check of the product and documents that it was conducted using positive identification.(D) Any unused starting ingredient that is not labeled as a multiple dose container must be discarded after preparation is complete.(E) Unless administered immediately, the drug product described in this paragraph shall bear a label listing the name of the drug (if not legible) and date and time prepared or beyond-use date.Ohio Admin. Code 4729:7-2-02
Effective: 7/1/2021
Five Year Review (FYR) Dates: 07/01/2026
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3715.69, 3719.28
Rule Amplifies: 3715.521, 3715.63, 3715.64, 3719.05, 4729.28, 4729.55