Bill Text: NY A02397 | 2019-2020 | General Assembly | Introduced


Bill Title: Enacts the "topical medication safety and efficacy act"; relates to the dispensing of topical pharmaceuticals.

Spectrum: Partisan Bill (Democrat 3-0)

Status: (Introduced - Dead) 2020-01-08 - referred to higher education [A02397 Detail]

Download: New_York-2019-A02397-Introduced.html


                STATE OF NEW YORK
        ________________________________________________________________________
                                          2397
                               2019-2020 Regular Sessions
                   IN ASSEMBLY
                                    January 22, 2019
                                       ___________
        Introduced by M. of A. PICHARDO -- read once and referred to the Commit-
          tee on Higher Education
        AN  ACT  to amend the education law, in relation to creating the topical
          medication safety and efficacy act
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
     1    Section  1.  Short  title. This act shall be known and may be cited as
     2  the "topical medication safety and efficacy act."
     3    § 2. Legislative findings and intent. The legislature recognizes  that
     4  medicine  is  an  important  and  ever-changing field marked by constant
     5  advances in knowledge and methods. Modern  pharmaceutical  research  has
     6  expanded the ability of physicians to heal their patients, but these new
     7  discoveries  require  not  just  new  chemical compounds, but also occa-
     8  sionally require new methods of administering treatments and  distribut-
     9  ing  medicines  to patients. For some topically applied medications, the
    10  safety and efficacy of the treatments are  enhanced  when  patients  can
    11  obtain  their  medicines  directly from their physicians and immediately
    12  learn correct application techniques  under  the  doctor's  supervision.
    13  This  is  especially  true in the case of medications used to treat skin
    14  discoloration affecting people of color. Due to the sensitivity  of  the
    15  skin  and  eyes,  patients often require additional guidance from physi-
    16  cians in the proper administration of treatments,  and  this  method  of
    17  instruction  coupled  with  dispensing  by  physicians  currently  helps
    18  millions of patients around the country. Unfortunately, New  York  state
    19  law has failed to similarly keep pace with medical developments, and New
    20  York  is  one  of  only  five  states  in  the nation that prohibits the
    21  dispensing of medications by physicians. This has  resulted  in  certain
    22  medications  not being as accessible to New York patients as they are in
    23  other states, keeping some patients away from  desired  treatments,  and
    24  driving others out of state to obtain treatment.
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD06347-01-9

        A. 2397                             2
     1    §  3.  Section  6802  of  the education law is amended by adding a new
     2  subdivision 29 to read as follows:
     3    29. "Topical pharmaceutical" means:
     4    a. Bimatoprost;
     5    b. Hydroquinone;
     6    c. Metronidazole;
     7    d. Tretinoin;
     8    e. Imiquimod;
     9    f. Acyclovir; or
    10    g. a drug that:
    11    (1) is not a controlled substance;
    12    (2) requires a prescription for dispensation;
    13    (3)  has been registered with or approved by the federal food and drug
    14  administration; and
    15    (4) is prescribed for the skin, the treatment of a skin condition,  or
    16  the enhancement of an individual's appearance.
    17    § 4. Subparagraph 9 of paragraph a of subdivision 2 of section 6807 of
    18  the  education  law,  as  amended by chapter 538 of the laws of 2001, is
    19  amended and a new subparagraph 10 is added to read as follows:
    20    (9) the dispensing of drugs pursuant to an oncological or AIDS  proto-
    21  col[.]; or
    22    (10)  the  dispensing  of  a  topical  pharmaceutical in excess of the
    23  patient's immediate needs when dispensed by a licensed prescriber, where
    24  the licensed prescriber:
    25    i. to the extent a topical pharmaceutical is available at a  pharmacy,
    26  informs the patient that the prescription may be filled at a pharmacy or
    27  dispensed in the licensed prescriber's office;
    28    ii. dispenses only to the licensed prescriber's patients;
    29    iii. believes that dispensing would improve the safety and efficacy of
    30  the drug or compliance with treatment by that patient; and
    31    iv.  complies  with  all state and federal labeling and record keeping
    32  requirements applicable to the topical pharmaceutical.  A  record  main-
    33  tained under this subparagraph must be accessible to the extent required
    34  by  state  and  federal  law. A licensed prescriber may charge a fee for
    35  dispensing a topical pharmaceutical.
    36    § 5. This act shall take effect immediately.
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