New York Codes, Rules and Regulations
Title 8 - EDUCATION DEPARTMENT
Chapter II - Regulations of the Commissioner
Subchapter B - Regulation of Professions
Part 63 - Pharmacy and registered pharmacy technicians
Section 63.9 - Immunizations and emergency treatment of anaphylaxis pursuant to patient specific and non-patient specific orders and protocols

(i) the pharmacist meets the requirements for a certificate of administration prescribed in paragraph (3) of this subdivision and the order and protocol meet the requirements set forth in paragraph (5) of this subdivision; and

(ii) with respect to non-patient specific orders:

(i) administer to patients 18 years of age or older, immunizing agents to prevent influenza, pneumococcal, acute herpes zoster, hepatitis A, hepatitis B, human papillomavirus, measles, mumps, rubella, varicella, COVID-19, meningococcal, tetanus, diphtheria, or pertussis disease, pursuant to a patient specific order or a non-patient specific order;

(ii) administer to patients between the ages of two and 18 years of age, immunizing agents to prevent influenza, pursuant to a patient specific order or a non-patient specific order; and

(iii) administer other immunizations recommended by the advisory committee on immunization practices of the centers for disease control and prevention for patients 18 years of age or older, pursuant to a patient specific or a non-patient specific order, if the commissioner of health in consultation with the commissioner determines that an immunization:

(i) Training course. Completion of a training course in the administration of immunizations acceptable to the commissioner and the Commissioner of Health, within the three years immediately preceding application for a certificate of administration. Such course shall include, but not be limited to, instruction in:

(ii) Training course associated with Doctor of Pharmacy degree:

(iii) Certificate of administration issued by another jurisdiction:

(i) prior to administering an immunization agent, a certified pharmacist shall ensure that each potential recipient is assessed for contraindications that would preclude immunization(s);

(ii) a certified pharmacist shall be responsible for having emergency anaphylaxis treatment agents, related syringes and needles available at the location at which immunizations will be administered;

(iii) a certified pharmacist shall inform each recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, of potential side effects and adverse reactions, orally and in writing, prior to immunization and shall administer the immunization or immunizations according to the most current recommendations by the advisory committee for immunization practices (ACIP), provided, however, that a pharmacist may administer any immunization authorized when specified by a patient specific prescription;

(iv) a certified pharmacist shall not administer immunizations unless the recipient is adequately informed as prescribed in this paragraph and the recipient consents to the immunization; except for recipients incapable of consenting to the administration of an immunization, in which case, before an immunization may be administered, either a person legally responsible for the recipient shall have given prior written consent to the immunization after having been informed in writing of potential side effects and adverse reactions, or a person legally responsible for the recipient is in attendance during the immunization and consents to the immunization after having been informed of potential side effects and adverse reactions;

(v) a certified pharmacist shall not allow a certified pharmacy intern to administer immunizations unless the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, is informed that the pharmacy intern will be administering the immunization and the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, consents to administration of the immunization by the certified pharmacy intern. If the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, does not consent to administration by the certified pharmacy intern, then the option to receive the immunization from a certified pharmacist shall be provided.

(vi) a certified pharmacist shall provide written instructions to the recipient regarding the appropriate course of action in the event of contraindications or adverse reactions, which statements are required to be developed by a competent entity knowledgeable about the adverse reactions of the immunization agent which shall be administered, such as the Centers for Disease Control of the U.S. Department of Health and Human Services, which issues vaccine information statements;

(vii) a certified pharmacist, when administering an immunization in a pharmacy, shall provide for an area that provides for the patient's privacy, such area shall include:

(viii) a certified pharmacist shall provide a copy of the appropriate vaccine information statement to the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, before administering the immunization;

(ix) a certified pharmacist shall provide to each recipient or other person legally responsible when the recipient is incapable of consenting to immunization, a signed certificate of immunization with the recipient's name, date of immunization, address of administration, administering pharmacist, immunization agent, manufacturer and lot number. With the consent of the recipient or a person legally responsible when the recipient is incapable of consenting, the certified pharmacist shall communicate this information to the recipient's primary health care practitioner, if one exists, within one month of the administration of such immunization, and such communication may be transmitted in electronic format;

(x) a certified pharmacist shall report any adverse outcomes as may be required by Federal law on the vaccine adverse event reporting system form of the Centers for Disease Control of the U.S. Department of Health and Human Services, or on the successor form;

(xi) a certified pharmacist shall ensure that a record of all persons immunized including the recipient's name, date, address of administration, administering pharmacist, immunization agent, manufacturer and lot number is recorded and maintained in accordance with section 29.2(a)(3) of this Title;

(xii) to the extent required by the Public Health Law, the Education Law and/or the New York City Health Code, a certified pharmacist shall report the administration of any immunizations to the New York State Department of Health and/or the New York City Department of Health and Mental Hygiene, in a manner required by the Commissioner of Health of the State of New York or of the City of New York, as applicable. Such report shall not include any individually identifiable health information unless:

(xiii) each certified pharmacist shall provide information to recipients on the importance of having a primary health care practitioner, in a form or format developed by the Commissioner of Health;

(xiv) each certified pharmacist shall, prior to administering the immunization or immunizations, inform the recipient, or the person legally responsible for the recipient when the patient is incapable of consenting to the immunization, of the total cost of the immunization or immunizations, subtracting any health insurance subsidization, if applicable. In the case where the immunization is not covered, the pharmacist shall inform the recipient, or other person legally responsible for the recipient when the patient is incapable of consenting to the immunization, that the immunization may be covered when administered by a primary care physician or health care practitioner; and

(xv) Reporting of administration of immunizing agent;

(i) each certified pharmacist shall ensure that a record of all persons to whom such pharmacist has administered an anaphylaxis treatment agent, including but not limited to: the recipient's name, date, address of administration, administering pharmacist, anaphylaxis treatment agent, manufacturer, and lot number, is recorded and maintained in either a patient medication profile, if one is required, that is prepared and retained in conformity with section 63.6(b)(7) of this Part; or, in the event that a patient medication profile is not required, on a separate form retained by the pharmacist who administered the anaphylaxis treatment agent and shall be maintained in accordance with section 29.2(a)(3) of this Title;

(ii) each certified pharmacist shall contact the local emergency medical services system following the administration of the anaphylaxis treatment agent, or shall ensure that equivalent follow-up care is provided through other arrangements; and

(iii) certified pharmacists shall report to the local emergency medical system or other provider of equivalent follow-up care information concerning the administration of the anaphylaxis treatment agent, including but not limited to: the name of the agent, when it was administered, the dosage, strength, and route of administration. Certified pharmacists shall also report such information to the patient's primary health care practitioner if one exists, unless the patient is unable to communicate the identity of his or her primary health care practitioner.

(i) The certified pharmacist shall either maintain or ensure the maintenance of a copy of the non-patient specific order and protocol prescribed by a licensed physician or a certified nurse practitioner that authorizes such pharmacist to administer medications for the emergency treatment of anaphylaxis to patients 2 years of age or older, in accordance with the requirements of paragraph (1) of this subdivision. The order prescribed in subparagraph (ii) of this paragraph shall incorporate a protocol that meets the requirements of subparagraph (iii) of this paragraph. Such order and protocol shall be considered a record of the patient who receives the anaphylaxis treatment agent and maintained as a record for the patient who receives the anaphylaxis treatment agent. A record of each patient shall be maintained in either:

(ii) The non-patient specific order shall authorize one or more named certified pharmacists, or certified pharmacists who are not individually named but are identified as employed or under contract with an entity that is legally authorized to employ or contract with pharmacists to provide pharmaceutical services, to administer specified anaphylaxis treatment agents in specified circumstances for a prescribed period of time. In instances in which the certified pharmacists are not individually named in the order, but are identified as employed or under contract with an entity that is legally authorized to employ or contract with certified pharmacists to provide pharmaceutical services, such pharmacists shall not be authorized by such order to administer anaphylaxis treatment agents outside of such employment or contract. The order shall contain but shall not be limited to the following information:

(iii) The protocol, incorporated into the order prescribed in subparagraph (ii) of this paragraph, shall include, but need not be limited to, the requirements set forth in paragraph (2) of this subdivision.