S T A T E   O F   N E W   Y O R K
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                                 4313--A

                       2015-2016 Regular Sessions

                            I N  S E N A T E

                             March 12, 2015
                               ___________

Introduced  by  Sen.  SEWARD -- read twice and ordered printed, and when
  printed to be committed  to  the  Committee  on  Higher  Education  --
  committee  discharged,  bill amended, ordered reprinted as amended and
  recommitted to said committee

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:

  Section 1. Short title. This act shall be known and may  be  cited  as
the "topical medication safety and efficacy act."
  S  2. Legislative findings and intent. The legislature recognizes that
medicine is an important and  ever-changing  field  marked  by  constant
advances  in  knowledge  and methods. Modern pharmaceutical research has
expanded the ability of physicians to heal their patients, but these new
discoveries require not just new  chemical  compounds,  but  also  occa-
sionally  require new methods of administering treatments and distribut-
ing medicines to patients. For some topically applied  medications,  the
safety  and  efficacy  of  the treatments are enhanced when patients can
obtain their medicines directly from their  physicians  and  immediately
learn  correct  application  techniques  under the doctor's supervision.
This is especially true in the case of medications used  to  treat  skin
discoloration  affecting  people of color. Due to the sensitivity of the
skin and eyes, patients often require additional  guidance  from  physi-
cians  in  the  proper  administration of treatments, and this method of
instruction  coupled  with  dispensing  by  physicians  currently  helps
millions  of  patients around the country. Unfortunately, New York state
law has failed to similarly keep pace with medical developments, and New
York is one of only  five  states  in  the  nation  that  prohibits  the
dispensing  of  medications  by physicians. This has resulted in certain
medications not being as accessible to New York patients as they are  in

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD09872-03-5

              

S. 4313--A                          2

other  states,  keeping  some patients away from desired treatments, and
driving others out of state to obtain treatment.
  S  3.  Section  6802  of  the education law is amended by adding a new
subdivision 27 to read as follows:
  27. "TOPICAL PHARMACEUTICAL" MEANS:
  A. BIMATOPROST;
  B. HYDROQUINONE;
  C. METRONIDAZOLE;
  D. TRETINOIN;
  E. IMIQUIMOD;
  F. ACYCLOVIR; OR
  G. A DRUG THAT:
  (1) IS NOT A CONTROLLED SUBSTANCE;
  (2) REQUIRES A PRESCRIPTION FOR DISPENSATION;
  (3) HAS BEEN REGISTERED WITH OR APPROVED BY THE FEDERAL FOOD AND  DRUG
ADMINISTRATION; AND
  (4)  IS PRESCRIBED FOR THE SKIN, THE TREATMENT OF A SKIN CONDITION, OR
THE ENHANCEMENT OF AN INDIVIDUAL'S APPEARANCE.
  S 4. Subparagraph 9 of paragraph a of subdivision 2 of section 6807 of
the education law, as amended by chapter 538 of the  laws  of  2001,  is
amended and a new subparagraph 10 is added to read as follows:
  (9)  the dispensing of drugs pursuant to an oncological or AIDS proto-
col[.]; OR
  (10) THE DISPENSING OF A  TOPICAL  PHARMACEUTICAL  IN  EXCESS  OF  THE
PATIENT'S IMMEDIATE NEEDS WHEN DISPENSED BY A LICENSED PRESCRIBER, WHERE
THE LICENSED PRESCRIBER:
  I.  TO THE EXTENT A TOPICAL PHARMACEUTICAL IS AVAILABLE AT A PHARMACY,
INFORMS THE PATIENT THAT THE PRESCRIPTION MAY BE FILLED AT A PHARMACY OR
DISPENSED IN THE LICENSED PRESCRIBER'S OFFICE;
  II. DISPENSES ONLY TO THE LICENSED PRESCRIBER'S PATIENTS;
  III. BELIEVES THAT DISPENSING WOULD IMPROVE THE SAFETY AND EFFICACY OF
THE DRUG OR COMPLIANCE WITH TREATMENT BY THAT PATIENT; AND
  IV. COMPLIES WITH ALL STATE AND FEDERAL LABELING  AND  RECORD  KEEPING
REQUIREMENTS  APPLICABLE  TO  THE TOPICAL PHARMACEUTICAL. A RECORD MAIN-
TAINED UNDER THIS SUBPARAGRAPH MUST BE ACCESSIBLE TO THE EXTENT REQUIRED
BY STATE AND FEDERAL LAW. A LICENSED PRESCRIBER MAY  CHARGE  A  FEE  FOR
DISPENSING A TOPICAL PHARMACEUTICAL.
  S 5. This act shall take effect immediately.