24:6M-4 Conditions relative to program.

4. a. Donated drugs and administration supplies may be accepted, transferred, and dispensed by a redistributor pursuant to this act, provided that the following conditions are satisfied:

(1) the donated drugs are contained in a sealed and tamper-evident package that remains intact;

(2) the donated drugs and administration supplies are dispensed to an eligible individual by a pharmacist or other health care professional who is authorized by law to dispense over-the-counter drugs and prescription drugs;

(3) the dispensing pharmacist or other health care professional determines, prior to dispensing a donated drug, that the donated drug is not adulterated or misbranded;

(4) the dispensing pharmacist or other health care professional dispenses any donated prescription drugs or prescription administration supplies to eligible individuals only pursuant to a valid prescription;

(5) the dispensed drugs and administration supplies are in a new container or have had all previous patient information on the donated container redacted or removed;

(6) the dispensed drugs and administration supplies are properly labeled in accordance with the regulations of the board;

(7) the dispensed drugs and administration supplies have an expiration or beyond use date brought forward from the donated drug that will not expire before the use by the patient based on the prescribing practitioner's directions for use or, for over-the-counter drugs, on the package's label; and

(8) an out-of-State redistributor complies with all laws and rules in this State unless such laws or rules differ or conflict with the laws or rules of the state in which the redistributor is located.

b. A redistributor may accept over-the-counter drugs, prescription drugs, and administration supplies from a donor located in another state, provided that the transfer is permitted under the laws of that other state.

c. (1) A redistributor may repackage donated over-the-counter drugs, prescription drugs, or administration supplies before transferring, storing, or dispensing the donated drugs or administration supplies to an eligible individual, or before transferring the donated drugs or administration supplies to another redistributor.

(2) Repackaged drugs shall be labeled with the drug name, strength, and expiration date, and shall be kept in a separate designated area until inspected and initialed by a pharmacist or other health care professional.

(3) If multiple packaged donated drugs with varied expiration dates are repackaged together, the shortest expiration date shall be used.

d. Donated drugs and administration supplies shall be segregated from other drug stocks, by either physical or electronic means.

e. (1) A redistributor's receipt of reimbursement or payment from another redistributor, a governmental agency, a pharmacy benefit manager, a pharmacy services administration organization, or a health care coverage program under this section, including a usual and customary charge, shall not be deemed to constitute the resale of prescription drugs for the purposes of this act, or for the purposes of any other law or regulation.

(2) A redistributor may also charge a handling fee to an eligible individual who is dispensed a donated drug pursuant to this act, provided that, if the redistributor is for-profit, the fee does not exceed the reasonable costs of procuring, transporting, inspecting, repackaging, storing, and dispensing the donated drug. A redistributor that charges a handling fee pursuant to this paragraph shall maintain a record validating the charge, and shall make that record available to the department upon request.

f. (1) If a donor receives notice from a pharmacy or pharmaceutical manufacturer regarding the recall of a donated over-the-counter drug or prescription drug, or of donated administration supplies, the donor shall provide notice of the recall to the redistributor who received the recalled over-the-counter drug, prescription drug, or administration supplies, unless the redistributor has provided the donor with a written statement attesting that the redistributor receives recall notices for all transferred and dispensed drugs through other means.

(2) If a redistributor receives notice of a recall pursuant to paragraph (1) of this subsection, the redistributor shall provide notice of the recall to any other redistributor to whom it has transferred the recalled over-the-counter drugs, prescription drugs, or administration supplies, unless the subsequent redistributor has provided the previous redistributor with a written statement attesting that the subsequent redistributor receives recall notices for all transferred and dispensed drugs through other means.

(3) Any redistributor who receives a notice of recall shall perform a uniform destruction of all of the recalled over-the-counter drugs, prescription drugs, or administration supplies in its possession.

g. Prior to the first donation from a new donor, a redistributor shall verify and record the following as a donor record, and no other donor information shall be required:

(1) the donor meets the definition of donor under this act;

(2) the donor's name, address, phone number, and license number, if applicable;

(3) certification that the donor will not donate any controlled dangerous substances; and

(4) certification that, if applicable, the donor will remove or redact any patient names and prescription numbers on donated drugs or otherwise maintain patient confidentiality by executing a confidentiality agreement with the redistributor.

h. A drug manufacturer, repackager, pharmacy, or wholesaler other than a returns processor participating in this program shall comply with the requirements of 21 U.S.C. ss.360eee-1 through 360eee-4 relating to drug supply chain security.

i. Donated drugs and administration supplies not accepted by the redistributor shall be disposed by returning the drugs or supplies to the donor, destroying the drugs or supplies by an incinerator or other lawful method, or transferring it to a returns processor. A record of disposed drugs and administration supplies shall consist of the disposal method as described above, the date of disposal, and the name, strength, and quantity of each drug disposed and the name and quantity of any administration supplies disposed. No other record of disposal shall be required.

j. All donated drugs and administration supplies received but not yet accepted into inventory shall be kept in a separate designated area. Prior to or upon accepting a donation or transfer into inventory, a redistributor shall maintain a written or electronic inventory of the donation, consisting of the transaction date, the name, strength, and quantity of each accepted drug and the name and quantity of any accepted administration supplies, and the name, address, and phone number of the donor. This record shall not be required if the two parties are under common ownership or common control. No other record of donation shall be required.

k. An authorized recipient shall store and maintain donated drugs physically or electronically separated from other inventory and in a secure and temperature controlled environment that meets the drug manufacturers' recommendations and United States Pharmacopeial Convention (USP) standards.

l. All records required under this act shall be retained in physical or electronic format, on or off the redistributor's premises for a period of six years. A donor or redistributor may contract with one another or a third-party entity to create or maintain records on each other's behalf. An identifier, such as a serial number or barcode, may be used in place of information required by a record or label under this act if it allows for such information to be readily retrievable. An identifier shall not be used on patient labels when dispensing or administering a drug.

m. If a record of the transaction information or history of a donation is required, the history shall begin with the acceptance of the drugs, shall include all prior donations, and, if the drug was previously dispensed, shall only include drug information required to be on the patient label in accordance with board rules and regulations.

L.2017, c.254, s.4.