Ohio Admin. Code 4729:5-5-18 - Dispensing customized patient medication packages by an outpatient pharmacy

In lieu of dispensing two or more dangerous drugs in separate containers, a pharmacist practicing at an outpatient pharmacy may dispense a customized patient medication package. A customized patient medication package is a package for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms that complies with the following requirements:

(A) The package is designed, or each container is labeled, to indicate the day and time or period of time when the contents within each container are to be taken by the patient.

(B) The number of drugs placed in each container cannot exceed the capability of the container to prevent damage to the dosage forms.

(C) The quantity of the package dispensed may not be more than a thirty-one-day ninety-day supply.

(D) The labels must be of sufficient size to properly and clearly label a thirty-one-day ninety-day or less supply with all information required in accordance with this chapter of the Administrative Code, including the use of accessory labels.

(E) The package must include an expiration date or beyond-use date, which shall not exceed the expiration date on the manufacturer's container or six months from the date the drug was originally packaged, whichever date is earlier. If multiple manufacturer containers are used, the expiration date shall not exceed the expiration date on the manufacturer's container that will expire first or six months from the date the drug was originally repackaged, whichever date is earlier.

(F) Dangerous drugs which have been dispensed in a customized patient medication package may only be returned to stock or re-dispensed in accordance with all the following:

(1) The drugs have not been in the possession of the ultimate user; and

(2) The drugs have not been placed in the same container with another dangerous drug (i.e. did not come into direct contact with a different drug within the same container).

(G) The containers of a package are sealed or secured in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

(H) Any pharmacy dispensing customized patient medication packages in accordance with this rule must implement policies and procedures that will exclude drugs having any of the following characteristics from such packaging:

(1) The U.S.P. monograph or official labeling requires dispensing in the original container, unless there is documentation from the manufacturer stating otherwise;

(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 drugs require special packaging.

Notes

Ohio Admin. Code 4729:5-5-18

Effective: 10/1/2024
Five Year Review (FYR) Dates: 4/24/2024 and 10/01/2029
Promulgated Under: 119.03
Statutory Authority: 3715.69, 4729.26
Rule Amplifies: 3715.521, 3715.63, 3715.64
Prior Effective Dates: 03/01/1999, 12/01/2020