N.Y. Comp. Codes R. & Regs. tit. 8 § 60.12

Current through Register Vol. 46, No. 36, September 4, 2024

Section 60.12 - Orders to dispense drugs to prevent human immunodeficiency virus (HIV) infection

(a) As used in this section, HIV post-exposure prophylaxis drugs means drugs approved by the Federal Food and Drug Administration to prevent and/or treat HIV infection.

(b) A licensed physician may issue a written non-patient specific order and protocol for a licensed pharmacist to dispense up to a seven day supply of HIV post-exposure prophylaxis drugs to prevent HIV infection in persons who have potentially been exposed to HIV, provided that the requirements of this section are met.

(c)Order and protocol.

(1) The non-patient specific order shall include, at a minimum, the following:

(i) the name, license number and signature of the licensed physician who issues the non-patient specific order and protocol;

(ii) the name and dose of the specific drug(s) to be dispensed;

(iii) a protocol for dispensing the drugs(s) or a specific reference to a separate written protocol for dispensing the drug(s), which shall meet the requirements of subparagraph (ii) of this paragraph;

(iv) the period of time that the order is effective, including the beginning and ending dates;

(v) a description of the group(s) of persons who may receive the dispensed drugs, provided that the group(s) of persons are located in New York State; and

(vi) the name and license number of each licensed pharmacist authorized to execute the non-patient specific order and protocol or the name and address of the New York State licensed pharmacy that employs or contracts with the licensed pharmacist(s) to execute the non-patient specific order and protocol.

(2) The written protocol, incorporated into the order prescribed in subparagraph (i) of this paragraph, shall, at a minimum, require the licensed pharmacist to:

(i) screen each potential recipient, pursuant to criteria in the protocol, for conditions that would qualify or preclude the potential recipient from receiving the dispensed drugs;

(ii) offer counseling regarding the need for follow-up care pursuant to criteria in the protocol and provide the counseling if the recipient consents;

(iii) offer or provide in writing, the names and addresses of hospitals or other health providers that offer follow-up care, which shall be identified in the protocol; and

(iv) document the pharmacy services provided, including the offer or provision of counseling and referral information described in this subparagraph, and maintain the documentation in accordance with sections 29.2(a)(3), 63.6(b)(7) and (8) of this Title.

(d) A licensed physician may issue a written patient specific order or prescription to a licensed pharmacist to dispense HIV post-exposure prophylaxis drugs pursuant to applicable law.

N.Y. Comp. Codes R. & Regs. Tit. 8 § 60.12

Adopted New York State Register June 28, 2017 /Volume XXXIX, Issue 26, eff.6/28/2017