4729-9-21 Drugs compounded in a pharmacy.

(A) In order to compound prescriptions, a pharmacy shall meet the minimum standards for a pharmacy pursuant to rule 4729-9-02 of the Administrative Code.

(B) Parenteral and sterile product prescriptions shall be compounded in accordance with Chapter 4729-19 and/or Chapter 4729-15 of the Administrative Code.

(C) For all compounded prescriptions, the pharmacist shall:

(1) Comply with the "United States Pharmacopeial Convention Chapter 795" when compounding non-sterile drug products;

(2) Comply with the "United States Pharmacopeial Convention Chapter 797" when compounding sterile compounded drug products;

(3) Comply with section 503A of the Federal Food, Drug, and Cosmetic Act (11/27/2013).

(4) Inspect and approve the compounding process;

(5) Perform the final check of the finished product.

(D) For all compounded prescriptions, the pharmacist shall be responsible for:

(1) All compounding records;

(2) The proper maintenance, cleanliness, and use of all equipment used in compounding.

(E) Personnel engaged in the compounding of drugs shall wear clean clothing appropriate to the operation being performed. Protective apparel shall be worn as necessary to protect personnel from chemical exposure and drug products from contamination.

(F) A prescription shall be compounded and dispensed only pursuant to a specific order for an individual patient issued by a prescriber. A limited quantity may be compounded in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

(G) A compounded prescription that is dispensed to a patient must be labeled according to rule 4729-5-16 of the Administrative Code.

(H) Labels for a compounded prescription that is prepared in anticipation of a prescription drug order shall contain, but not be limited to, the following:

(1) The name, strength, and quantity of each drug used in the compounded prescription;

(2) The identification of the repackager by name or by the final seven digits of its terminal distributor of dangerous drugs license number;

(3) Pharmacy control number;

(4) The pharmacy's expiration date or beyond use date.

Effective: 01/01/2015
R.C. 119.032 review dates: 06/06/2014 and 01/01/2019
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 3719.28 , 4729.26
Rule Amplifies: 3715.521 , 3715.63 , 3715.64 , 3719.05 , 4729.28 , 4729.55
Prior Effective Dates: 7/1/1994, 3/1/1999, 2/1/2005, 1/1/09