6512.1A pharmacist shall not administer immunizations and vaccinations unless certified by the Board of Pharmacy in accordance with this section to do so.
6512.2An applicant for certification to administer immunizations and vaccinations shall do the following:
(a) Submit a completed application and pay the required fee;(b) Demonstrate to the satisfaction of the Board that he or she: (1) Is licensed in good standing under the Act to practice pharmacy;(2) Possesses an active certification in cardiopulmonary resuscitation for health care providers; and(3) Has successfully completed an ACPE approved course approved by the Board of Pharmacy which: (ii) Includes study material;(iii) Includes hands-on training in techniques for administering immunizations or vaccines;(iv) Requires testing with a passing score;(v) Meets current Center for Disease Control and Prevention training guidelines; and(vi) Provides a minimum of twenty (20) hours of instruction and hands-on training in:(A) Basic immunology and vaccine protection;(B) Vaccine-preventable diseases;(C) Vaccine storage and management;(E) Physiology and techniques for vaccine administration;(F) Pre and post-vaccine assessment and counseling;(G) Immunization record management; and(H) Identification, appropriate response, documentation, and reporting of adverse events.6512.3A pharmacist certified by the Board to administer immunizations and vaccinations shall:
(a) Maintain current certification in cardiopulmonary resuscitation for health care providers;(b) Complete two (2) hours of continuing education each renewal period relevant to the administration of immunizations and vaccinations, as part of the continuing education credits required under subsection 6513.4 of this chapter and submit proof upon request to the Board; and(c) Administer vaccines and immunizations in accordance with CDC guidelines.6512.4The location in the pharmacy where vaccinations and immunizations are administered shall:
(b) Be maintained to promote an aseptic environment;(c) Have adequate telecommunications devices to summon aid and communicate emergency situations; and(d) Have adequate equipment and supplies to respond to adverse events and emergency situations6512.5(a) Except as provided in paragraph (b), a pharmacist certified by the Board to administer immunizations and vaccinations shall only administer immunizations and vaccinations pursuant to: (1) A written protocol signed and dated by a District of Columbia licensed physician authorizing the administration upon receipt of a written protocol; and(2)(A) A valid prescription; or(B) Physician standing order.(b) The requirement for a written protocol and prescription or a standing order with a District of Columbia licensed physician shall not apply to FDA-authorized or FDA-licensed COVID-19 vaccines, or seasonal influenza vaccinations, until November 1, 2024, or until Sections V(f) and V(h) of the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (85 FR 15198, Mar. 17, 2020), as amended, expire, whichever occurs later.6512.6A copy of the written protocol required in §§6512.5 shall be maintained by the administering pharmacist at the pharmacy practice site and readily available for inspection upon request of the Board of Pharmacy or submitted to the Board for review upon request.
6512.7The written protocol shall contain, at a minimum, the following:
(a) A statement identifying the individual physician authorized to prescribe drugs and responsible for the delegation of administration of immunizations or vaccinations;(b) A statement identifying the individual pharmacist(s) authorized to administer immunizations or vaccinations as delegated by the physician;(c) A statement identifying the patient or groups of patients to receive the authorized immunization or vaccination; which shall be limited to: (1) Patients who are currently under the individual physician's care or with whom the physician has provided medical treatment or care within the twelve months prior to the date of the written protocol;(2) Patients who are currently under the practice's care or with whom a physician within the practice has provided medical treatment or care within the twelve months prior to the date of the written protocol;(3) Residents of a health care, residential services, or assisted living facility, when the medical director of such facility is the physician making the delegation;(4) District resident populations identified by the Director of the Department of Health as part of a public health services program, when the Director, or his or her designee, is the physician making the delegation;(5) Inmates of the District of Columbia jail, when the medical director for the facility is the physician making the delegation; or(6) Any person aged three (3) and older with parental consent, or valid identification if eighteen (18) or older or otherwise capable of consenting to the vaccination pursuant to Section 2 of the Consent for Vaccinations of Minors Amendment Act of 2022, effective March 10, 2023 (D.C. Law 24-12; D.C. Official Code §§71653.01), for any vaccination that the Advisory Committee on Immunization Practices ("ACIP") recommends according to ACIP's standard immunization schedule, or any vaccination that ACIP recommends that has been officially adopted by the Director of the Centers for Disease Control and Prevention; and(d) A statement identifying the location(s) at which the pharmacist may administer immunizations or vaccinations which shall not include where a patient resides, except for a licensed nursing home, residential care facility, assisted living center, the District of Columbia jail, or a hospital;(e) A statement identifying the immunizations and vaccinations and emergency anaphylactic reaction treatment that may be administered by the pharmacist;(f) A statement identifying the activities the pharmacist shall follow in the course of administering immunizations and vaccinations, including procedures to follow in the case of reactions following administration; and(g) A statement that describes the content of, and the appropriate mechanisms for the pharmacist to report the administration of immunizations and vaccinations to both the patient's primary physician, if applicable and sufficiently identified by the patient, and to the physician issuing the written protocol, if not the same person, within the time frames specified in the protocol; which shall include providing the physician(s) with a copy of the following records: (1) The name, address, gender, allergies, and date of birth of the individual receiving the immunization or vaccination;(2) The date of administration;(3) The route and site of the immunization or vaccination;(4) The name, dose, manufacturer's lot number, and expiration date of the vaccine;(5) The name of the pharmacist administering the immunization or vaccination; and(6) Any adverse events encountered.6512.8The pharmacist shall review the written protocol annually with the physician.
6512.9 Except as provided in §§6512.10, a pharmacist certified by the Board of Pharmacy to administer immunizations and vaccinations shall not administer an immunization or vaccination to any individual younger than three (3) years old.
6512.10 A pharmacist certified by the Board of Pharmacy to administer immunizations and vaccinations shall only administer an immunization or vaccination to an individual under the age of three (3) upon a referral from a physician who has an established physician-patient relationship with the patient.
6512.11Except as provided in §§6512.12, a pharmacist certified to administer immunizations and vaccinations shall not delegate any function or duty, in part or in whole, pertaining to the administration of immunizations and vaccinations.
6512.12 A pharmacist certified to administer immunizations and vaccinations may permit a registered pharmacy intern or registered pharmacy technician to administer FDA-authorized or FDA-licensed COVID-19 vaccines, or seasonal influenza vaccinations, under the pharmacist's direct supervision to an individual who is eighteen (18) years of age or older; provided, that the registered pharmacy intern or registered pharmacy technician has successfully completed a Board of Pharmacy-approved ACPE-approved course meeting the requirements of §§6512.2(b)(3).
6512.13Every patient receiving an immunization or vaccination by a pharmacist certified to do so, shall be provided with:
(a) A current vaccine information statement; and(b) A copy of the administration records required in §§6512.7(g).6512.14The pharmacist shall obtain the patient's informed written consent prior to administering the immunization or vaccination.
6512.15As part of the informed consent, the practitioner and the pharmacist shall provide written disclosure to the patient of any contractual arrangement with any other party or any financial incentive that may impact one of the party's decisions to participate in the agreement.
6512.16The pharmacist shall maintain a copy of the patient's informed written consent on file at the pharmacy practice site where the administration was given for a period of two (2) years after the date of administration.
6512.17The pharmacist shall maintain documentation at the pharmacy practice site where the immunization or vaccination was administered for a period of two (2) years that includes:
(a) The name, address, gender, allergies and date of birth of the individual receiving the immunization or vaccination;(b) The date of administration(c) The route and site of the immunization or vaccination;(d) The name, dose, manufacturer's lot number, and expiration date of the vaccine;(e) The name and address of the primary health care provider of the individual receiving the immunization or vaccination as identified to the pharmacist by that individual;(f) The date on which the vaccination or immunization information was reported to the delegating physician and to the primary care physician, if applicable;(g) The name of the pharmacist administering the immunization or vaccination;(h) The version of the vaccination information statement provided to the patient;(i) A copy of the signed patient informed consent form; and(j) Any adverse events encountered.6512.18The records required to be maintain pursuant to this chapter shall be readily available for inspection upon request of the Board of Pharmacy or submitted to the Board for review upon request.
6512.19A pharmacist certified under this chapter may administer the vaccinations and immunizations, and emergency anaphylactic reaction treatment deemed appropriate by the delegating physician as specifically set forth in the written protocol.
6512.20The administering pharmacist shall report the immunizations and vaccinations administered as required under any federal or District Immunization Information System or Immunization Registry or as otherwise agreed in the written protocol.
6512.21The administering pharmacist shall report any adverse event, which occurs in connection with or related to an administration to:
(a) The Department of Health's Pharmaceutical Control Division within forty-eight (48) hours after discovery of the occurrence; and(b) The Director of the Department of Health as required under the District's Mandatory Adverse Event Reporting law and regulations in D.C. Official Code §§ 7-161 (2011 Supp.) and 17 DCMR §§4017.4.D.C. Mun. Regs. tit. 17, r. 17-6512
Final Rulemaking published at 36 DCR 6243, 6252 (September 1, Final Rulemaking published at 36 DCR 6243, 6252 (September 1, 1989); as amended by Final Rulemaking published at 55 DCR 4330 (April 18, 2008); as amended by Final Rulemaking published at 56 DCR 5566 (July 10, 2009); as amended by Emergency and Proposed Rulemaking published at 56 DCR 8204 (October 16, 2009)[EXPIRED]; as amended by Final Rulemaking published at 56 DCR 9325-9326 (December 11, 2009; as corrected by Errata Notice published at 57 DCR 10514 (November 12, 2010); as corrected by Errata Notice published at 57 DCR 10761 (November 19, 2010); as amended by Notice of Final Rulemaking published at 59 DCR 3363 (June 8, 2012); amended by Final Rulemaking published at 70 DCR 13178 (10/7/2023); amended by Final Rulemaking published at 71 DCR 2151 (3/1/2024)Authority: The Director of the Department of Health, pursuant to the authority set forth under § 302(14) of the District of Columbia Health Occupation Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code § 3-1203.02(14) (2007 Repl.)) (Act), and Mayor's Order 98-140, dated August 20, 1998.