TITLE 26 FOOD, DRUGS, AND COSMETICS

Section 4. Pharmacists and Pharmacies, 26-4-1 through 26-4-214.

ARTICLE 12 PRESCRIPTION MEDICATION INTEGRITY ACT

26-4-201. (For effective date, see note.) Definitions.

As used in this article, the term:

1. "Authenticate" means to affirmatively verify before any wholesale distribution of a prescription drug occurs that each transaction listed on the pedigree has occurred.
2. "Authorized distributor of record" means a distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drugs.
3. "Board" means the State Board of Pharmacy.
4. "Broker" has the same meaning as a third-party logistics provider.
5. "Chain pharmacy warehouse" means a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales or transfers of such drugs to a group of chain pharmacies that have the same common ownership or control.
6. "Co-licensed pharmaceutical products" means pharmaceutical products:
   1. That have been approved by the federal Food and Drug Administration; and
   2. Concerning which two or more parties have the right to engage in a business activity or occupation concerning the pharmaceutical products.
7. "Co-licensee" means a party to a co-licensed pharmaceutical product.
8. "Distribute" means to deliver a drug or device other than by administering or dispensing.
9. "Drop shipment arrangement" means the physical shipment of a prescription from a manufacturer, that manufacturer's co-licensee, that manufacturer's third-party logistics provider, or that manufacturer's authorized distributor of record directly to a chain pharmacy warehouse, pharmacy buying cooperative warehouse, pharmacy, or other persons authorized under law to dispense or administer prescription drugs but wherein the sale and title for the prescription drug passes between a wholesale drug distributor and the party that directly receives the prescription drug. In order to be considered part of the normal distribution channel and participate in a drop shipment as described in this paragraph, the wholesale drug distributor must be an authorized distributor of record.
10. "Facility" means a facility of a wholesale distributor where prescription drugs are stored, handled, repackaged, or offered for sale.
11. "Manufacturer" means a person licensed or approved by the federal Food and Drug Administration to engage in the manufacture of drugs or devices, consistent with the definition of "manufacturer" under the regulations and interpreted guidances implementing the Prescription Drug Marketing Act.
12. "Manufacturer's exclusive distributor" means an entity that contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services for a manufacturer and takes title to that manufacturer's prescription drug. To be considered part of the normal distribution channel, a manufacturer's exclusive distribution must be an authorized distributor of record.
13. "Normal distribution channel" means a chain of custody for a prescription drug, excluding all devices and veterinary prescription drugs, that goes directly or by drop shipment from a manufacturer of the prescription drug, or from that manufacturer to that manufacturer's co-licensed partner, or from that manufacturer to that manufacturer's third-party logistics provider, or from that manufacturer to that manufacturer's exclusive distributor, to:
    1. Either a pharmacy or to other designated persons authorized by law to dispense or administer such drug;
    2. An authorized distributor or record, and then to either a pharmacy, or to other designated persons authorized by law to dispense or administer such drug;
    3. An authorized distributor of record to one other authorized distributor of record to an office based health care practitioner authorized by law to dispense or administer such drug to a patient;
    4. An authorized distributor of record to a pharmacy warehouse or other entity that redistributes by intracompany sale to a pharmacy or other designated persons authorized to dispense or administer the drug;
    5. A pharmacy warehouse or other entity that redistributes by intracompany sale to a pharmacy or other designated persons authorized to dispense or administer the drug; or
    6. Another entity as prescribed by the board's regulations.
14. "Ongoing relationship" means an association that exists when a wholesale drug distributor, including any member of its affiliated group, as defined in Section 1504 of the Internal Revenue Code, of which the wholesale drug distributor is a member:
    1. Is listed on the manufacturer's list of authorized distributors of record, which is updated by the manufacturer on no less than a monthly basis; or
    2. Has a written agreement currently in effect with the manufacturer evidencing such ongoing relationship.
15. "Pedigree" means a document or electronic file containing information that records each distribution of any given prescription drug.
16. "Pharmacy buying cooperative warehouse" means a permanent physical location that acts as a central warehouse for drugs and from which sales of drugs are made to a group of pharmacies that are member owners of the buying cooperative operating the warehouse. Pharmacy buying cooperative warehouses must be licensed as wholesale distributors.
17. "Prescription drug" means any drug (including any biological product, except for blood and blood components intended for transfusion or biological products that are also medical devices) required by federal law (including federal regulation) to be dispensed only by a prescription, including finished dosage forms and bulk drug substances subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act.
18. "Repackage" means repackaging or otherwise changing the container, wrapper, or labeling to further the distribution of a prescription drug; provided, however, that this shall not apply to pharmacists in the dispensing of prescription drugs to the patient.
19. "Repackager" means a person who repackages.
20. "Third-party logistics provider" means an entity that provides or coordinates warehousing, distribution, or other services on behalf of a manufacturer but does not take title to a drug or have general responsibility to direct the sale or other disposition of the drug. To be considered part of the normal distribution channel, a third party logistics provider must be an authorized distributor of record.
21. "Wholesale distributor" means any person engaged in wholesale distribution of drugs, including but not limited to repackagers; own label distributors; private label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail and hospital pharmacies and chain pharmacy warehouses that conduct wholesale distributions. This term shall not include manufacturers.
22. "Wholesale distribution" shall not include:
    1. Intracompany sales of prescription drugs, meaning any transaction or transfer between any division, subsidiary, parent, or affiliated or related company under common ownership or control of a corporate entity, except that nothing contained herein shall be construed to prohibit the board from requiring that other records of these transactions shall be kept in accordance with law and regulation not found in this article;
    2. The sale, purchase, distribution, trade, or transfer of a prescription drug or offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons including transfers of a prescription drug from retail pharmacy to retail pharmacy, except that nothing contained herein shall be construed to prohibit the board from requiring that other records of these transactions shall be kept in accordance with law and regulation not found in this article;
    3. The distribution of prescription drug samples by manufacturers' representatives;
    4. Prescription drug returns when conducted by a retail pharmacy or chain pharmacy warehouse, by a hospital, health care entity, or charitable institution in accordance with 21 C.F.R. Section 203.23, or by any designated persons authorized by law to dispense or administer the prescription drug except in cases where a pedigree is already required under the provisions of this article, in which case any return of that prescription drug to a wholesaler or manufacturer shall be subject to the provisions of Code Section 26-4-202;
    5. The sale of minimal quantities of prescription drugs by retail pharmacies to licensed practitioners for office use, except that nothing contained herein shall be construed to prohibit the board from requiring that other records of these transactions shall be kept in accordance with law and regulation not found in this article;
    6. Retail pharmacies' delivery of prescription drugs to a patient or patient's agent pursuant to the lawful order of a licensed practitioner;
    7. The delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier's usual course of business of transporting prescription drugs, and such common carrier does not store, warehouse, or take legal ownership of the prescription drug;
    8. The sale or transfer from a retail pharmacy, pharmacy buying cooperative warehouse, or chain pharmacy warehouse of expired, damaged, returned, or recalled prescription drugs to the original manufacturer, originating wholesale distributor, or to a third party returns processor, to the extent permitted by federal rule, regulation, or law; or
    9. The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy or pharmacies from or with another pharmacy or pharmacies, whether accomplished as a purchase and sale of stock or business assets.

(Code 1981, §26-4-201, enacted by Ga. L. 2007, p. 463, § 2/SB 205; Ga. L. 2013, p. 141, § 26/HB 79.)