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Chapter 480-9 MULTIPLE DRUGS IN SINGLE-DOSING CONTAINERS

Rule 480-9-.01 Definitions

For purposes of these Rules and Regulations, the following definition applies:

(a) Multi-Drug Single-Dosing Container. A multi-drug single-dosing container is a customized single-dosing package labeled by a pharmacy for a specific patient, and such package contains two or more solid, oral dosage form drugs to be administered to or taken by a specific patient at the same dosage time from a single container.

Rule 480-9-.02 Labeling

Each individual, customized, multi-drug single-dosing container shall bear a label, which at a minimum, contains the following:

(a) The name of the patient;
(b) The name of the prescribing practitioner of each drug;
(c) The name, address, and telephone number of the pharmacy issuing the multi-drug single dosing container;
(d) The identifying serial number assigned to the prescription drug order for each drug contained therein;
(e) The name, strength, physical description, and total quantity of each drug contained therein;
(f) The directions for use, and/or time of administration or time to be taken for each individual multi-drug single-dosing container; and
(g) Either the dispensing or preparation date, as well as a beyond use (expiration) date for each drug contained in the multi-drug single-dosing container; The expiration date of each drug included therein shall not be longer than one (1) year from the date of preparation of the multi-drug single-dosing container.

Rule 480-9-.03 Conditions

The conditions for allowing Multi-drug Single-dosing containers shall be as follows:

(a) The number of drugs placed in one package cannot exceed the capacity of the container in order to prevent damage to the individual dosage forms;
(b) The total quantity of drugs dispensed may not be more than a thirty-four (34) day supply;
(c) The labels must be of sufficient size to properly and clearly label each container of a thirty-four (34) days or less drug supply with all information required by state and federal law and rules;
(d) The integrity of each individual multi-drug single-dosing container shall be maintained until the last drug dose is administered t or taken by the patient;
(e) Once a multi-drug single-dosing container has been properly labeled and dispensed to a patient, and this same container is returned to the pharmacy, the drugs packaged in such container are considered adulterated and may not be eturned to the pharmacy stock. Drugs may be redispensed only under the following conditions:
1. Drugs repackaged for and redispensed only to the same patient to which the drugs were originally dispensed or;
2. Whenever a patient has an allergic reaction to any drug contained in a multi-drug single-dosing container and this drug is discontinued from the patient's treatment, a pharmacy cannot repackage and redispense any drug(s) which were packaged with the discontinued drug in the single-dosing container, because any such drug is then considered to be adulterated as defined under O.C.G.A. 26-3.
3. Unopened unit-dose drugs packaged only by the original drug manufacturer dispensed to and returned only by a Long Term Care facility patient for Medicaid credit;
4. A multi-drug single-dosing container must be tamper evident in such a manner to prevent the container from being either reclosed or designed to show evidence of having been opened;
(f) Whenever a drug(s) in such a container previously dispensed to a patient has/have been discontinued, the remaining container(s) must be returned to the dispensing pharmacy for the removal of the discontinued drug(s) from the container for destruction. Except as provided for in paragraph 480-9-.03(5)(a)1, once the discontinued drug(s) has/have been removed, the pharmacy may repackage the drug(s) to be continued and once again only dispense them to the patient to whom they were originally dispensed. Under no circumstances may any of the renaining or discontinued drug(s) be returned to the drug stock of the pharmacy or dispensed to any patient other than the patient to whom the drugs were originally dispensed, as specified in 480-9-.03(5),(6) and (7).
(g) At the time of administration, nothing in this rule is meant to prevent a nurse or a patient specified caregiver from removing a discontinued drug(s) from a container to be wasted as directed by a pharmacist or from retaining up to a 72 hour supply of the continued drug(s) in the original container in order to maintain a patient on his or her continuing drug administration schedule;
(h) Any pharmacist or pharmacy using multi-drug single-dosing container must implement policies and procedures which will exclude any drug(s) which have the following characteristics from being utilized in such packaging:
1. The USP-DI monograph or official labeling requires dispensing in the original container;
2. The drugs are incompatible with packaging components or each other;
3. The drugs require special packaging.

Rule 480-9-.04 Redispensing by a Different Pharmacy

(1) Whenever a patient or the patient's caregiver requests a pharmacy to dispense medication in a multi-drug single-dosing container(s) which has/have been previously labeled and dispensed by another pharmacy, the following guidelines must be utilized:
(a) Whenever a patient or the patient's caregiver requests a pharmacy to remove drugs from containers previously dispensed by another pharmacy, and redispensed such drugs in a multi-drug single-dosing container(s), that pharmacy must first receive written permission from the patient or the patient's caregiver in the form of written and signed statement from that same patient or patient's caregiver. Each statement must be kept on file at the pharmacy, along with the corresponding redispensing log, as described in 480-9-.04(b), for a period of two (2) years.
(b) Whenever a pharmacy receives a written request, as described above in 480-9-.04(a) to redispense drugs in a multi-drug single-dosing container(s), and such drugs have been previously dispensed by another pharmacy, the pharmacy choosing to redispense must maintain a redispensing log using the following record keeping guidelines in addition to any record keeping already required by state and federal law or rules/regulations. The pharmacy is then considered the dispensing pharmacy. For each drug redispensed, this log must include at a minimum:
1. The name, address, and telephone number of the redispensing pharmacy;
2. The date the drug was redispensed;
3. The name and address of the patient;
4. The serial number on the label of the originally dispensed prescription drug container;
5. The name, address, and telephone number of the pharmay originally dispensing the drug;
6. The serial number assigned to the drug by the redispensing pharmacy;
7. The name, quantity, and identifying logo or numbers of the drug as it was originally dispensed and is now being redispensed;
8. The expiration date assigned to the drug being redispensed, with such date being no longer than one (1) year from the date of redispensing;
9. The name of the prescribing practitioner;
10. The directions for administration or taking as written by the prescribing physician;
11. Any special labeling information or instructions;
12. The name or initials of the pharmacist verifying the redispensed drug against the log and/or the original drug container;
(c) All redispensing logs, statements, and other such records required by this section are required to be maintained by the pharmacy for a minimum of two (2) years. Any and all such records shall be made available for inspection and/or copying by the Georgia Drugs and Narcotics Agency. The conditions on the use of the multi-drug single-dosing containers found in Rule 480-9-.03 also apply to the pharmacy redispensing pursuant to this rule.

Rule 480-9-.05 Exceptions

This rule does not apply to the labeling of multi-drug single-dosing containers dispensed by a hospital pharmacy to inpatients located within the same building as or on the immediate grounds where the hospital pharmacy is located.