S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   10396
 
                           I N  A S S E M B L Y
 
                               May 13, 2022
                                ___________
 
 Introduced  by  COMMITTEE ON RULES -- (at request of M. of A. Fernandez)
   -- read once and referred to the Committee on Higher Education
 
 AN ACT to amend the education law, in relation to the definition of  the
   practice  of  pharmacy;  and to repeal section 6801-a of the education
   law, relating to the  collaborative  drug  therapy  management  demon-
   stration program

   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Section 6801 of the education law, as  amended  by  chapter
 563  of  the laws of 2008, subdivision 1 as amended by chapter 21 of the
 laws of 2011, subdivisions 2 and 4 as amended by section 1 of part DD of
 chapter 57 of the laws of 2018, subdivision 5 as added by chapter 502 of
 the laws of 2016, subdivision 6 as added by chapter 134 of the  laws  of
 2021, and subdivision 7 as added by section 2 of part C of chapter 57 of
 the laws of 2022, is amended to read as follows:
   § 6801.  [Definition of practice] PRACTICE of pharmacy.  1. [The prac-
 tice of the profession of pharmacy  is  defined  as  the  administering,
 preparing,  compounding,  preserving,  or the dispensing of drugs, medi-
 cines and therapeutic devices on the basis  of  prescriptions  or  other
 legal authority, and collaborative drug therapy management in accordance
 with  the  provisions of section sixty-eight hundred one-a of this arti-
 cle.
   2. A licensed pharmacist may execute a  non-patient  specific  regimen
 prescribed  or  ordered  by  a physician licensed in this state or nurse
 practitioner certified in this state, pursuant to rules and  regulations
 promulgated  by the commissioner. When a licensed pharmacist administers
 an immunizing agent, he or she shall:
   (a) report such administration by electronic transmission or facsimile
 to the patient's attending primary health care practitioner  or  practi-
 tioners, if any, and, to the extent practicable, make himself or herself
 available  to  discuss  the  outcome of such immunization, including any
 adverse reactions, with the attending primary health care  practitioner,
 and  to the statewide immunization registry or the citywide immunization

  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD15628-01-2
              

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 registry, as established pursuant to and  to  the  extent  permitted  by
 section twenty-one hundred sixty-eight of the public health law; and
   (b)  provide  information  to  the  patient  or, where applicable, the
 person legally responsible for the patient, on the importance of  having
 a  primary  health  care  practitioner, developed by the commissioner of
 health; and
   (c) report such administration, absent of any  individually  identifi-
 able  health  information,  to  the  department  of  health  in a manner
 required by the commissioner of health; and
   (d) prior to administering the immunization, inform  the  patient  or,
 where applicable, the person legally responsible for the patient, of the
 total  cost of the immunization or immunizations, subtracting any health
 insurance subsidization, if applicable. In the case the immunization  is
 not  covered,  the pharmacist must inform the patient or, where applica-
 ble, the person legally responsible for the patient, of the  possibility
 that the immunization may be covered when administered by a primary care
 physician or practitioner; and
   (e) administer the immunization or immunizations according to the most
 current recommendations by the advisory committee for immunization prac-
 tices  (ACIP),  provided  however,  that a pharmacist may administer any
 immunization authorized under this section when specified by  a  patient
 specific order.
   3.  No pharmacist shall administer immunizing agents without receiving
 training satisfactory to the commissioner and the commissioner of health
 which shall include, but not be limited  to,  techniques  for  screening
 individuals  and  obtaining  informed  consent;  techniques  of adminis-
 tration; indications, precautions and contraindications in  the  use  of
 agent  or  agents;  record  keeping of immunization and information; and
 handling emergencies, including anaphylaxis and needlesticks.
   4. When administering an immunization  in  a  pharmacy,  the  licensed
 pharmacist  shall provide an area for the immunization that provides for
 a patient's privacy. The privacy area should include:
   a. a clearly visible posting of the most  current  "Recommended  Adult
 Immunization Schedule" published by the advisory committee for immuniza-
 tion practices (ACIP); and
   (b)  education  materials  on  influenza  vaccinations for children as
 determined by the commissioner and the commissioner of health.
   5. A licensed pharmacist may execute a non-patient specific order, for
 dispensing up to a seven day starter pack of HIV  post-exposure  prophy-
 laxis  medications  for the purpose of preventing human immunodeficiency
 virus infection, by a physician licensed in this state or nurse  practi-
 tioner  certified  in  this  state,  pursuant  to  rules and regulations
 promulgated by the commissioner in consultation with the commissioner of
 health following a potential human immunodeficiency virus exposure.
   6. A licensed pharmacist may execute a non-patient-specific regimen of
 insulin  and  related  supplies  to  an  individual  who  has  a   valid
 prescription  for  insulin  and related supplies which has since expired
 within the last twelve months. The valid  prescription  must  have  been
 prescribed  or  ordered  by  a physician licensed in this state or nurse
 practitioner certified in this state. Execution of a non-patient-specif-
 ic regimen shall be on an emergency basis provided the pharmacist:
   (a) first attempts to obtain an authorization from the  prescriber  of
 the  patient-specific  prescription and cannot obtain the authorization,
 and the prescriber does not object to dispensing to  the  patient  under
 the non-patient-specific regimen;
 A. 10396                            3

   (b)  provides  a  refill  of the patient-specific prescription and the
 quantity of that refill is in conformity with  the  directions  for  use
 under the patient-specific prescription, but limited to an amount not to
 exceed a thirty-day emergency supply; and
   (c)  notifies,  within  seventy-two  hours of dispensing the refill or
 refills, the  prescriber  of  the  patient-specific  prescription  whose
 authorization  could  not be obtained, that an emergency prescription of
 insulin has been dispensed.
   7. A licensed pharmacist is a qualified health care professional under
 section five hundred seventy-one  of  the  public  health  law  for  the
 purposes  of  directing  a  limited  service laboratory and ordering and
 administering COVID-19 and influenza tests authorized by  the  Food  and
 Drug Administration (FDA), subject to certificate of waiver requirements
 established  pursuant to the federal clinical laboratory improvement act
 of nineteen hundred eighty-eight.] "PRACTICE OF PHARMACY" MEANS:
   (A) THE INTERPRETATION, EVALUATION AND DISPENSING OF PRESCRIPTION DRUG
 ORDERS;
   (B) PARTICIPATION IN DRUG AND DEVICE SELECTION,  DRUG  ADMINISTRATION,
 PROSPECTIVE  AND  RETROSPECTIVE  DRUG  REVIEWS  AND DRUG OR DRUG-RELATED
 RESEARCH;
   (C) THE PROVISION OF PATIENT COUNSELING AND  THE  PROVISION  OF  THOSE
 ACTS OR SERVICES NECESSARY TO PROVIDE PHARMACEUTICAL CARE;
   (D) THE RESPONSIBILITY FOR:
   (I)  COMPOUNDING AND LABELING OF DRUGS AND DEVICES, EXCEPT LABELING BY
 A MANUFACTURER, REPACKAGER OR DISTRIBUTOR OF NONPRESCRIPTION  DRUGS  AND
 COMMERCIALLY PACKAGED LEGEND DRUGS AND DEVICES;
   (II)  PROPER  AND SAFE STORAGE OF DRUGS AND DEVICES AND MAINTENANCE OF
 PROPER RECORDS FOR SUCH DRUGS AND DEVICES; AND
   (III) THE OFFERING OR PERFORMING OF THOSE ACTS,  SERVICES,  OPERATIONS
 OR  TRANSACTIONS  NECESSARY  TO  THE  CONDUCT, OPERATION, MANAGEMENT AND
 CONTROL OF PHARMACY;
   (E) THE PRESCRIBING OF DRUGS, DRUG CATEGORIES,  OR  DEVICES  THAT  ARE
 LIMITED TO CONDITIONS THAT:
   (I) DO NOT REQUIRE A NEW DIAGNOSIS;
   (II) ARE MINOR AND GENERALLY SELF-LIMITING;
   (III)  HAVE  A  TEST THAT IS USED TO GUIDE DIAGNOSIS OR CLINICAL DECI-
 SION-MAKING  AND  ARE  WAIVED  UNDER  THE  FEDERAL  CLINICAL  LABORATORY
 IMPROVEMENT AMENDMENTS OF NINETEEN HUNDRED EIGHTY-EIGHT; OR
   (IV)  IN  THE  PROFESSIONAL  JUDGMENT  OF THE PHARMACIST, THREATEN THE
 HEALTH OR SAFETY OF THE PATIENT SHOULD THE  PRESCRIPTION  NOT  BE  IMME-
 DIATELY  DISPENSED.  IN  SUCH  CASES,  ONLY  SUFFICIENT  QUANTITY MAY BE
 PROVIDED UNTIL THE PATIENT IS ABLE TO BE SEEN BY ANOTHER PROVIDER.
   2. THE STATE BOARD OF PHARMACY SHALL NOT ADOPT ANY RULES AUTHORIZING A
 PHARMACIST TO PRESCRIBE A CONTROLLED DRUG.
   § 2. Section 6801-a of the education law is REPEALED.
   § 3. This act shall take effect immediately.