4729-9-23 Dispensing of multiple drugs in single-dose containers.

Multiple drugs may be packaged in the same container such that the different drugs are in contact with each other only under the following conditions:

(A) The number of drugs placed in one package cannot exceed the capability of the receptacle to prevent damage to the dosage forms.

(B) The quantity dispensed may not be more than a thirty-one-day supply.

(C) The labels must be of sufficient size to properly and clearly label a thirty-one-day or less supply with all information required by state and federal law including accessory labels.

(D) Each individual package must include a beyond-use date of not more than sixty days from the date the drugs were placed in the package.

(E) Medications which have been packaged in multi-dose packaging are considered adulterated if returned to the pharmacy for any reason and may not be returned to stock or re-dispensed.

(F) The packaging is tamper-evident.

(G) Any pharmacist or pharmacy using multi-dose packaging must implement policies and procedures which will exclude drugs having the following characteristics from such packaging:

(1) The U.S.P. monograph or official labeling requires dispensing in the original container;

(2) The drugs or dosage forms are incompatible with packaging components or each other;

(3) The drugs are therapeutically incompatible when administered simultaneously;

(4) The drug products require special packaging.

R.C. 119.032 review dates: 03/17/2014 and 03/17/2019
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 4729.26
Rule Amplifies: 3715.521 , 3715.63 , 3715.64
Prior Effective Dates: 03/01/1999