Bill Text: NY A08319 | 2019-2020 | General Assembly | Introduced


Bill Title: Relates to the practice of registered pharmacy technician; enacts provisions for the licensure of such persons.

Spectrum: Partisan Bill (Democrat 23-1)

Status: (Introduced) 2019-06-20 - substituted by s6517 [A08319 Detail]

Download: New_York-2019-A08319-Introduced.html



                STATE OF NEW YORK
        ________________________________________________________________________

                                          8319

                               2019-2020 Regular Sessions

                   IN ASSEMBLY

                                      June 13, 2019
                                       ___________

        Introduced  by  M.  of  A.  ROMEO,  GLICK,  PEOPLES-STOKES, ENGLEBRIGHT,
          MAGNARELLI, LIFTON, BENEDETTO, LUPARDO, STIRPE, BRONSON,  FAHY,  McDO-
          NALD,  SIMON, BICHOTTE, WALLACE, TAYLOR, BUTTENSCHON, EPSTEIN, McMAHON
          -- read once and referred to the Committee on Higher Education

        AN ACT to amend the education law, in relation to the practice of regis-
          tered pharmacy technician

          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:

     1    Section  1. The education law is amended by adding a new article 137-A
     2  to read as follows:
     3                                ARTICLE 137-A
     4                       REGISTERED PHARMACY TECHNICIANS
     5  Section 6840. Introduction.
     6          6841. Definition of the practice of registered pharmacy  techni-
     7                  cian.
     8          6842. Definitions.
     9          6843. Practice  of registered pharmacy technician and use of the
    10                  title "registered pharmacy technician".
    11          6844. Requirements for licensure as a registered pharmacy  tech-
    12                  nician.
    13    § 6840. Introduction. This article applies to the profession of regis-
    14  tered  pharmacy  technician.  The general provisions for all professions
    15  contained in article one hundred thirty of this  title  shall  apply  to
    16  this article.
    17    §  6841. Definition of the practice of registered pharmacy technician.
    18  1. A registered pharmacy  technician  may,  under  the  direct  personal
    19  supervision  of  a licensed pharmacist, assist such licensed pharmacist,
    20  as directed, in compounding, preparing, labeling, or dispensing of drugs
    21  used to fill valid prescriptions or medication orders or in compounding,
    22  preparing, and labeling in anticipation of a valid prescription or medi-
    23  cation order for a patient to be served by the facility,  in  accordance

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD13315-02-9

        A. 8319                             2

     1  with  article  one  hundred  thirty-seven of this title where such tasks
     2  require no professional judgment. Such professional judgment shall  only
     3  be  exercised by a licensed pharmacist. A registered pharmacy technician
     4  may  only  practice  in  a  facility licensed in accordance with article
     5  twenty-eight of the public health law, or a pharmacy owned and  operated
     6  by  such a facility, under the direct personal supervision of a licensed
     7  pharmacist employed in such a facility or pharmacy. Such facility  shall
     8  be  responsible for ensuring that the registered pharmacy technician has
     9  received appropriate training to ensure  competence  before  he  or  she
    10  begins assisting a licensed pharmacist in compounding, preparing, label-
    11  ing, or dispensing of drugs, in accordance with this article and article
    12  one  hundred  thirty-seven of this title. For the purposes of this arti-
    13  cle, direct personal supervision means supervision of  procedures  based
    14  on  instructions given directly by a supervising licensed pharmacist who
    15  remains in the immediate area where the procedures are being  performed,
    16  authorizes  the procedures and evaluates the procedures performed by the
    17  registered pharmacy technicians and a  supervising  licensed  pharmacist
    18  shall  approve  all work performed by the registered pharmacy technician
    19  prior to the actual dispensing of any drug.
    20    2. In addition to the registered pharmacy technician services included
    21  in subdivision one of this section, registered pharmacy technicians  may
    22  also assist a licensed pharmacist in the dispensing of drugs by perform-
    23  ing  the  following  functions  that do not require a license under this
    24  article:
    25    a. receiving  written  or  electronically  transmitted  prescriptions,
    26  except  that in the case of electronically transmitted prescriptions the
    27  licensed pharmacist or pharmacy intern shall review the prescription  to
    28  determine  whether  in  his  or  her  professional  judgment it shall be
    29  accepted by the pharmacy, and if accepted, the  licensed  pharmacist  or
    30  pharmacy  intern shall enter his or her initials into the records of the
    31  pharmacy;
    32    b. typing prescription labels;
    33    c. keying prescription data for entry into a  computer-generated  file
    34  or retrieving prescription data from the file, provided that such compu-
    35  ter-generated  file  shall  provide  for verification of all information
    36  needed to fill the prescription by a licensed pharmacist  prior  to  the
    37  dispensing  of  the  prescription,  meaning that the licensed pharmacist
    38  shall review and approve such information and enter his or her  initials
    39  or  other personal identifier into the recordkeeping system prior to the
    40  dispensing of the prescription or of the prescription refill;
    41    d. getting drugs from stock and returning them to stock;
    42    e. getting prescription files and other manual  records  from  storage
    43  and locating prescriptions;
    44    f. counting dosage units of drugs;
    45    g. placing dosage units of drugs in appropriate containers;
    46    h. affixing the prescription label to the containers;
    47    i.  preparing  manual  records  of  dispensing  for  the  signature or
    48  initials of the licensed pharmacist;
    49    j. handing or delivering completed prescriptions to the patient or the
    50  person authorized to act on behalf of the  patient  and,  in  accordance
    51  with  the  relevant  commissioner's regulations, advising the patient or
    52  person authorized to act on behalf of the patient of the availability of
    53  counseling to be  conducted  by  the  licensed  pharmacist  or  pharmacy
    54  intern; or
    55    k.  performing  other functions as defined by the commissioner's regu-
    56  lations.

        A. 8319                             3

     1    3. Under the direct personal supervision  of  a  licensed  pharmacist,
     2  unlicensed  persons  who  are  not  registered  pharmacy technicians may
     3  assist licensed pharmacists in performing  tasks  that  do  not  require
     4  licensure in accordance with regulations promulgated by the commissioner
     5  and  are  also  described in subdivision two of this section. Unlicensed
     6  persons who are not registered pharmacy technicians shall not engage  in
     7  or assist in compounding.
     8    4. No licensed pharmacist shall obtain the assistance of more than two
     9  registered  pharmacy  technicians  in  the performance of licensed tasks
    10  within their scope of  practice  or  four  unlicensed  persons,  in  the
    11  performance  of  the activities that do not require licensure, the total
    12  of such persons shall not exceed  four  individuals  at  any  one  time.
    13  Pharmacy  interns  shall be exempt from such ratios, but shall be super-
    14  vised in accordance with commissioner's regulations. Individuals who are
    15  responsible for the act of placing drugs which are in unit-dose  packag-
    16  ing into medication carts as part of an approved unit-dose drug distrib-
    17  ution system for patients in institutional settings shall be exempt from
    18  such  ratio,  provided  that  such  individuals  are not also engaged in
    19  performing the activities set forth in subdivision one or  paragraph  b,
    20  c,  d, e, f, g, h, or i of subdivision two of this section. The licensed
    21  pharmacist shall provide the degree of supervision of  such  persons  as
    22  may  be appropriate to ensure compliance with the relevant provisions of
    23  regulations of the commissioner.
    24    § 6842. Definitions. As used in this article:
    25    1. "Licensed pharmacist" means a person licensed to practice  pharmacy
    26  pursuant to article one hundred thirty-seven of this title.
    27    2.  "Pharmacy intern" means a person practicing under a limited permit
    28  pursuant to section sixty-eight hundred six of this title.
    29    3. "Professional judgment" means  professional  decision-making  by  a
    30  licensed pharmacist, including, but not limited to, such activities as:
    31    a.  interpreting  a  prescription  or medication order for therapeutic
    32  acceptability and appropriateness or engaging in the calculations behind
    33  any such formulations;
    34    b. interpreting and evaluating a prescription or medication order  for
    35  conformance  with  legal requirements, authenticity, accuracy and inter-
    36  action of the prescribed drug with other known prescribed  and  over-the
    37  -counter drugs;
    38    c. receiving oral prescriptions from prescribers; or
    39    d. counseling patients.
    40    4.  "Compounding"  means  the  combining,  admixing, mixing, diluting,
    41  pooling, reconstituting, or otherwise altering of a drug  or  bulk  drug
    42  substance to create a drug.
    43    5.  "Drugs",  "pharmacopeia", "labeling" and "sterile drug" shall have
    44  the same definitions as set forth in section sixty-eight hundred two  of
    45  this title.
    46    §  6843.  Practice  of  registered  pharmacy technician and use of the
    47  title "registered pharmacy technician". Only a person licensed to  prac-
    48  tice as a registered pharmacy technician under this article or otherwise
    49  authorized shall practice as a registered pharmacy technician or use the
    50  title "registered pharmacy technician."
    51    §  6844.  Requirements  for licensure as a registered pharmacy techni-
    52  cian. To qualify for licensure as a "registered pharmacy technician", an
    53  applicant shall fulfill the following requirements:
    54    1. Application: file an application with the department;
    55    2. Education: have received an education, including high school gradu-
    56  ation or its equivalent, as determined by the department;

        A. 8319                             4

     1    3. Certification from  a  nationally  accredited  pharmacy  technician
     2  certification program acceptable to the department;
     3    4. Age: at the time of application be at least eighteen years of age;
     4    5.  Character: be of good moral character as determined by the depart-
     5  ment; and
     6    6. Fee: pay a fee determined by the department for initial license and
     7  for each triennial registration period.
     8    § 2. The education law is amended by adding a new section 6832 to read
     9  as follows:
    10    § 6832. Limitations on assistance of an unlicensed person.  1. Subject
    11  to the limitations set forth in subdivision  two  of  this  section,  an
    12  unlicensed  person may assist a licensed pharmacist in the dispensing of
    13  drugs by:
    14    (a) receiving written  or  electronically  transmitted  prescriptions,
    15  except  that in the case of electronically transmitted prescriptions the
    16  licensed pharmacist or pharmacy intern shall review the prescription  to
    17  determine  whether  in  his  or  her  professional  judgment it shall be
    18  accepted by the pharmacy, and if accepted, the  licensed  pharmacist  or
    19  pharmacy  intern shall enter his or her initials into the records of the
    20  pharmacy;
    21    (b) typing prescription labels;
    22    (c) keying prescription data for entry into a computer-generated  file
    23  or retrieving prescription data from the file, provided that such compu-
    24  ter-generated  file  shall  provide  for verification of all information
    25  needed to fill the prescription by a licensed pharmacist  prior  to  the
    26  dispensing  of  the  prescription,  meaning that the licensed pharmacist
    27  shall review and approve such information and enter his or her  initials
    28  or  other personal identifier into the recordkeeping system prior to the
    29  dispensing of the prescription or of the prescription refill;
    30    (d) getting drugs from stock and returning them to stock;
    31    (e) getting prescription files and other manual records  from  storage
    32  and locating prescriptions;
    33    (f) counting dosage units of drugs;
    34    (g) placing dosage units of drugs in appropriate containers;
    35    (h) affixing the prescription label to the containers;
    36    (i)  preparing  manual  records  of  dispensing  for  the signature or
    37  initials of the licensed pharmacist;
    38    (j) handing or delivering completed prescriptions to  the  patient  or
    39  the person authorized to act on behalf of the patient and, in accordance
    40  with  the  relevant  commissioner's regulations, advising the patient or
    41  person authorized to act on behalf of the patient of the availability of
    42  counseling to be  conducted  by  the  licensed  pharmacist  or  pharmacy
    43  intern; and
    44    (k)  performing other functions as defined by the commissioner's regu-
    45  lations.
    46    2. Except for a licensed pharmacist employed by a facility licensed in
    47  accordance with article twenty-eight of the public health law or a phar-
    48  macy owned and operated by such a facility, as defined  in  article  one
    49  hundred  thirty-seven-A  of  this  title,  no  licensed pharmacist shall
    50  obtain the assistance of more  than  four  unlicensed  persons,  in  the
    51  performance  of  the activities that do not require licensure, the total
    52  of such persons shall not exceed four individuals at any one time. Phar-
    53  macy interns shall be exempt from such ratios, but shall  be  supervised
    54  in  accordance with the commissioner's regulations.  Individuals who are
    55  responsible for the act of placing drugs which are in unit-dose  packag-
    56  ing into medication carts as part of an approved unit-dose drug distrib-

        A. 8319                             5

     1  ution system for patients in institutional settings shall be exempt from
     2  such  ratio,  provided  that  such  individuals  are not also engaged in
     3  performing the activities set forth in paragraph  (b),  (c),  (d),  (e),
     4  (f),  (g),  (h)  or (i) of subdivision one of this section. The licensed
     5  pharmacist shall provide the degree of supervision of  such  persons  as
     6  may  be appropriate to ensure compliance with the relevant provisions of
     7  regulations of the commissioner.
     8    § 3. Section 6804 of the education law, as added by chapter 987 of the
     9  laws of 1971, is amended to read as follows:
    10    § 6804. State board of pharmacy.  A state board of pharmacy  shall  be
    11  appointed  by  the regents on recommendation of the commissioner for the
    12  purpose of assisting the  regents  and  the  department  on  matters  of
    13  professional  licensing  and  professional  conduct  in  accordance with
    14  section sixty-five hundred eight of  this  title.  The  board  shall  be
    15  composed of not less than nine pharmacists licensed in this state for at
    16  least  five  years  and two registered pharmacy technicians. The initial
    17  registered pharmacy technician members of the state  board  of  pharmacy
    18  need  not  be licensed prior to their appointment but shall have met all
    19  other requirements of licensure pursuant to section sixty-eight  hundred
    20  forty-two  of  this  title except for filing an application and paying a
    21  fee.  An executive secretary to the board  shall  be  appointed  by  the
    22  regents  on recommendation of the commissioner and shall be a pharmacist
    23  licensed in this state for at least five years. The  board  shall  [have
    24  power] provide assistance to the department:
    25    a.  To  regulate the practice of pharmacy, registered pharmacy techni-
    26  cians and the employment of interns and employees in pharmacies,
    27    b. To regulate and control the sale, distribution, character and stan-
    28  dard of drugs, poisons, cosmetics, devices and new drugs,
    29    c. [To employ inspectors and chemists,
    30    d.] To prevent the  sale  or  distribution  of  such  drugs,  poisons,
    31  cosmetics,  devices and new drugs as do not conform to the provisions of
    32  this article or of the public health law,
    33    [e.] d. To investigate alleged violations of the  provisions  of  this
    34  article[,  through  its  own  investigative  personnel or those of other
    35  agencies, to conduct hearings, to levy money  penalties,  and  to  bring
    36  alleged violations to the notice of the attorney general], and
    37    [f.] e. To issue limited permits or registrations.
    38    §  4.  This  act shall take effect eighteen months after it shall have
    39  become a law; provided, however, that the  department  of  education  is
    40  authorized  to  promulgate  regulations that may be required and to take
    41  other measures necessary to implement the provisions of this  act  prior
    42  to such effective date, including appointment of two registered pharmacy
    43  technicians to the state board of pharmacy, and the acceptance and proc-
    44  essing of applications for licensure.
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