NY Educ L § 6810 (2021)
2021 New York Laws EDN - Education Title 8 - The Professions Article 137 - Pharmacy 6810 - Prescriptions.

§ 6810. Prescriptions. 1. No drug for which a prescription is required by  the  provisions of the Federal Food, Drug and Cosmetic Act or by the commissioner of health shall be distributed or dispensed to  any  person except  upon  a  prescription  written by a person legally authorized to issue such prescription. Such drug shall be compounded or dispensed by a licensed pharmacist,  and  no  such  drug  shall  be  dispensed  without affixing  to  the  immediate  container  in  which  the  drug is sold or dispensed a label bearing the name and  address  of  the  owner  of  the establishment in which it was dispensed, the date compounded, the number of  the  prescription  under  which  it  is recorded in the pharmacist's prescription files, the name of the prescriber, the name and address  of the  patient,  and the directions for the use of the drug by the patient as given upon the prescription. All labels shall conform to  such  rules and  regulations  as promulgated by the commissioner pursuant to section sixty-eight hundred twenty-nine of this  article.  The  prescribing  and dispensing of a drug which is a controlled substance shall be subject to additional  requirements  provided in article thirty-three of the public health law. The words "drug" and "prescription required drug" within the meaning of this article shall not be construed to include soft  or  hard contact  lenses,  eyeglasses,  or  any  other  device  for  the  aid  or correction of vision.  Nothing  in  this  subdivision  shall  prevent  a pharmacy  from furnishing a drug to another pharmacy which does not have such drug in stock for the purpose of filling a prescription.   2. (a) A prescription may not be refilled unless it bears  a  contrary instruction  and  indicates  on  its  face the number of times it may be refilled. A prescription may not be refilled more times than allowed  on the  prescription.  The  date of each refilling must be indicated on the original prescription. Prescriptions for controlled substances shall  be refilled only pursuant to article thirty-three of the public health law.   A   pharmacy  registered  with  the  department  pursuant  to  section sixty-eight hundred eight or sixty-eight hundred eight-b of this article may not deliver a new or refilled prescription off premises without  the consent  of  the  patient  or an individual authorized to consent on the patient's behalf. For the purposes  of  this  section,  consent  may  be obtained  in  the  same  manner  and  process by which consent is deemed acceptable under the federal Medicare Part D program.  (b) Pharmacy providers  who  deliver  medication  without  patient  or authorized  individual  consent will be required to accept the return of the medication from the patient, provide that  patient  credit  for  any charges  they  may  have  paid,  and  will  be required to destroy those medications  sent  without  consent  on  delivery  in  accordance   with applicable  state  and  federal  law.  Nothing  in this section shall be deemed to  interfere  with  the  requirements  for  refill  reminder  or medication  adherence  programs.  Nothing in this section is intended to apply to long-term care pharmacy dispensing and delivery.   3. A copy of a prescription for a controlled substance  shall  not  be furnished   to  the  patient  but  may  be  furnished  to  any  licensed practitioner authorized to write  such  prescription.  Copies  of  other prescriptions shall be furnished to the patient at his request, but such copies  are  issued  for  the  informational purposes of the prescribers only, and shall be so worded.   4. (a) Oral prescriptions for controlled substances  shall  be  filled pursuant  to article thirty-three of the public health law. A pharmacist may fill an oral prescription  for  a  drug,  other  than  a  controlled substance, made by a practitioner legally authorized to prescribe drugs. An  oral  authorization  for  the refill of a prescription, other than a prescription for a controlled substance, may be made by  a  practitioner legally  authorized  to  prescribe  drugs. The pharmacist receiving such  oral authorization for the refill of a prescription shall write  on  the reverse  side  of  the original prescription the date, time, and name of the practitioner authorizing the refill of  the  prescription.  An  oral prescription  or  an oral authorization for the refill of a prescription for the drug, other than a controlled substance, may be communicated  by an  employee  of  the  prescribing  practitioner; provided, however, the pharmacist shall:  (i) contemporaneously reduce such prescription to writing;  (ii)  dispense  the  substance  in  conformity   with   the   labeling requirements applicable to a written prescription; and  (iii)  make  a  good faith effort to verify the employee's identity if the employee is unknown to the pharmacist.  (b) Oral prescriptions for  patients  in  general  hospitals,  nursing homes,   residential  health  care  facilities  as  defined  in  section twenty-eight hundred one of the public health law, hospitals as  defined in  subdivision  ten  of  section  1.03  of  the  mental hygiene law, or facilities  operated  by  the  office  for  people  with   developmental disabilities, may be communicated to a pharmacist serving as a vendor of pharmaceutical services based upon a contractual arrangement by an agent designated  by  and  under  the  direction  of  the  prescriber  or  the institution. Such agent shall be a health  care  practitioner  currently licensed and registered under this title.   5. Records of all prescriptions filled or refilled shall be maintained for  a period of at least five years and upon request made available for inspection and copying by  a  representative  of  the  department.  Such records  shall  indicate  date  of  filling or refilling, doctor's name, patient's name and address and the name or initials  of  the  pharmacist who  prepared,  compounded,  or  dispensed  the prescription. Records of prescriptions for controlled substances shall be maintained pursuant  to requirements of article thirty-three of the public health law.   6. (a) Every prescription written in this state by a person authorized to issue such prescription shall be on prescription forms containing one line  for  the  prescriber's signature. The prescriber's signature shall validate the prescription. Every electronic prescription  shall  provide for  the  prescriber's  electronic  signature,  which shall validate the electronic prescription. Imprinted conspicuously on  every  prescription written  in  this state in eight point upper case type immediately below the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX  BELOW".  Unless the  prescriber  writes  d  a  w  in  such  box  in the prescriber's own handwriting or, in the case  of  electronic  prescriptions,  inserts  an electronic  direction  to dispense the drug as written, the prescriber's signature  or  electronic  signature   shall   designate   approval   of substitution by a pharmacist of a drug product pursuant to paragraph (o) of  subdivision one of section two hundred six of the public health law. No other letters or marks in such box shall  prohibit  substitution.  No prescription forms used or intended to be used by a person authorized to issue a prescription shall have 'd a w' preprinted in such box. Such box shall  be  placed  directly  under  the  signature  line  and  shall  be three-quarters inch in  length  and  one-half  inch  in  height,  or  in comparable  form  for  an electronic prescription as may be specified by regulation of the commissioner. Immediately  below  such  box  shall  be imprinted   in   six   point  type  the  words  "Dispense  As  Written". Notwithstanding any other provision of law, no state  official,  agency, board  or  other  entity  shall  promulgate  any regulation or guideline modifying those elements of the prescription form's  contents  specified in  this  subdivision.  To  the  extent  otherwise  permitted  by law, a prescriber may modify only those elements  of  the  prescription  form's  contents  not  specified  in this subdivision. Notwithstanding any other provision of this section or any other law, when a generic drug  is  not available and the brand name drug originally prescribed is available and the  pharmacist  agrees  to  dispense the brand name product for a price that will not exceed the price that would  have  been  charged  for  the generic substitute had it been available, substitution of a generic drug product  will  not  be  required.  If  the  generic  drug product is not available and a medical emergency situation, which for purposes of  this section is defined as any condition requiring alleviation of severe pain or  which  threatens  to  cause  disability or take life if not promptly treated, exists, then the pharmacist may dispense the brand name product at his regular price. In such instances the pharmacist must  record  the date,  hour  and  nature  of  the  medical  emergency on the back of the prescription and keep a copy of all such prescriptions.   * (b) Notwithstanding any other provision of this section or any other law, when an interchangeable biological product is not available and the biological product originally prescribed is available and the pharmacist agrees to dispense the prescribed biological product for  a  price  that will  not  exceed  the  price  that  would  have  been  charged  for the interchangeable   biological   substitute   had   it   been   available, substitution  of  an  interchangeable  biological  product  will  not be required. If the interchangeable biological product is not available and a medical emergency situation, which for purposes  of  this  section  is defined  as  any condition requiring alleviation of severe pain or which threatens to cause disability or take  life  if  not  promptly  treated, exists,  then  the  pharmacist  may  dispense  the prescribed biological product at his regular price. In  such  instances  the  pharmacist  must record the date, hour and nature of the medical emergency on the back of the prescription and keep a copy of all such prescriptions.   * NB Effective until October 23, 2022   * (b)  The  prescriber  shall inform the patient whether he or she has prescribed a brand name or its generic equivalent drug product.   * NB Effective October 23, 2022   * (c) The prescriber shall inform the patient whether he  or  she  has prescribed  a  brand  name  or  its  generic  equivalent drug product or interchangeable biological product.   * NB Effective until October 23, 2022   * (c) The provisions of this subdivision shall not apply to a hospital as defined in article twenty-eight of the public health law.   * NB Effective October 23, 2022   * (d) The provisions of this subdivision shall not apply to a hospital as defined in article twenty-eight of the public health law.   * NB Effective until October 23, 2022   * (d) No prescriber shall be  subjected  to  civil  liability  arising solely  from  authorizing,  in  accordance  with  this  subdivision, the substitution by a pharmacist of a drug product pursuant to paragraph (o) of subdivision one of section two hundred six of the public health law.   * NB Effective October 23, 2022   * (e) No prescriber shall be  subjected  to  civil  liability  arising solely  from  authorizing,  in  accordance  with  this  subdivision, the substitution by a pharmacist of a drug product pursuant to paragraph (o) of subdivision one of section two hundred six of the public health law.   * NB Expires October 23, 2022   7. (a) No prescription for a drug written in this state  by  a  person authorized  to  issue  such prescription shall be on a prescription form which authorizes the dispensing or compounding of  any  other  drug.  No drug  shall  be  dispensed  by  a pharmacist when such prescription form includes any other drug.  (b) With respect  to  drugs  other  than  controlled  substances,  the provisions  of  this subdivision shall not apply to pharmacists employed by or providing services under contract to  general  hospitals,  nursing homes,   residential  health  care  facilities  as  defined  in  section twenty-eight  hundred one of the public health law, hospitals as defined in subdivision ten of  section  1.03  of  the  mental  hygiene  law,  or facilities   operated  by  the  office  for  people  with  developmental disabilities, who dispense drugs in the course of said employment or  in the  course  of  providing such services under contract. With respect to such pharmacists, each prescription shall be transcribed  on  a  patient specific prescription form.   8.  Every  prescription  (whether  or  not for a controlled substance) written in this state by a person authorized to issue such  prescription and  containing  the  prescriber's  signature shall, in addition to such signature, be imprinted or stamped legibly and  conspicuously  with  the printed  name  of  the  prescriber  who has signed the prescription. The imprinted or stamped name of the signing prescriber shall appear  in  an appropriate  location  on the prescription form and shall not be entered in or upon any space or line reserved for  the  prescriber's  signature. The imprinted or stamped name shall not be employed as a substitute for, or   fulfill   any   legal  requirement  otherwise  mandating  that  the prescription be signed by the prescriber.   9. No person, corporation, association or other entity,  not  licensed to  issue  a  prescription  pursuant to this title, shall wilfully cause prescription forms, blanks or facsimiles thereof to be  disseminated  to any  person  other than a person who is licensed to issue a prescription pursuant to this title. A violation of this subdivision shall be a class B misdemeanor punishable in accordance with the provisions of the  penal law.   10.  Notwithstanding  any other provision of this section or any other law to the contrary, effective three years subsequent  to  the  date  on which  regulations  establishing  standards for electronic prescriptions are promulgated by the commissioner of health, in consultation with  the commissioner  pursuant  to  subdivision  three  of  section  two hundred eighty-one of the public health law, no  practitioner  shall  issue  any prescription  in  this  state,  unless  such  prescription  is  made  by electronic prescription from the practitioner to a pharmacy, except  for prescriptions:  (a)  issued by veterinarians; (b) issued or dispensed in circumstances where electronic  prescribing  is  not  available  due  to temporary   technological   or  electrical  failure,  as  set  forth  in regulation; (c) issued by practitioners who have received a waiver or  a renewal thereof for a specified period determined by the commissioner of health,  not  to exceed one year, from the requirement to use electronic prescribing, pursuant to a process  established  in  regulation  by  the commissioner  of  health,  in  consultation with the commissioner due to economic hardship, technological limitations  that  are  not  reasonably within   the   control   of   the  practitioner,  or  other  exceptional circumstance  demonstrated  by  the  practitioner;  (d)  issued   by   a practitioner    under    circumstances    where,   notwithstanding   the practitioner's present ability to make  an  electronic  prescription  as required  by  this  subdivision, such practitioner reasonably determines that it would be  impractical  for  the  patient  to  obtain  substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the patient's medical condition, provided that if such  prescription is for a controlled substance, the quantity that does not exceed a five day supply if the controlled  substance  was  used  in accordance  with the directions for use; or (e) issued by a practitioner  to be dispensed by a pharmacy located outside the state, as set forth in regulation.   10-a.  A  pharmacy  that  receives an electronic prescription from the person issuing the prescription may, if the prescription  has  not  been dispensed  and  at  the request of the patient or a person authorized to make the request on behalf  of  the  patient,  immediately  transfer  or forward  such  prescription to an alternative pharmacy designated by the requesting party.   11. In the case of a  prescription  issued  by  a  practitioner  under paragraph (b) of subdivision ten of this section, the practitioner shall be  required  to  indicate  in  the  patient's  health  record  that the prescription was issued  other  than  electronically  due  to  temporary technological or electrical failure.   12.  In  the  case  of  a  prescription issued by a practitioner under paragraph  (d)  or  (e)  of  subdivision  ten  of  this   section,   the practitioner  shall,  upon  issuing  such  prescription, indicate in the patient's health record either that the prescription  was  issued  other than   electronically  because  it  (a)  was  impractical  to  issue  an electronic prescription in a timely manner and  such  delay  would  have adversely  impacted  the  patient's  medical condition, or (b) was to be dispensed by a pharmacy located outside the state.   13. The waiver process established in regulation pursuant to paragraph (c) of subdivision ten of this section shall provide that a practitioner prescribing under a waiver must  notify  the  department  of  health  in writing   promptly   upon  gaining  the  capability  to  use  electronic prescribing, and that a waiver shall terminate within a specified period of time after the practitioner gains such capability.   14. Notwithstanding any other provision of law  to  the  contrary,  no outsourcing  facility  may distribute or dispense any drug to any person pursuant to a prescription unless it is also registered as a pharmacy in this state and meets all other applicable requirements  of  federal  and state law.   *  15.  Notwithstanding  any  other  provisions of this section or any other law to the contrary, a practitioner shall not be required to issue prescriptions electronically if he or she certifies to the department of health, in a manner specified by the department of health,  that  he  or she  will  not issue more than twenty-five prescriptions during a twelve month period. Prescriptions in both  oral  and  written  form  for  both controlled substances and non-controlled substances shall be included in determining whether the practitioner will reach the limit of twenty-five prescriptions.  (a)  A certification shall be submitted in advance of the twelve-month certification period, except that a twelve-month certification submitted on or before  on  July  first,two  thousand  sixteen,  may  begin  March twenty-seventh, two thousand sixteen.  (b) A practitioner who has made a certification under this subdivision may  submit  an  additional certification on or before the expiration of the current twelve-month certification period, for a  maximum  of  three twelve-month certifications.  (c)  A  practitioner  may  make a certification under this subdivision regardless of whether he or she has previously received a  waiver  under paragraphs (c) of subdivision ten of this section.   * NB Repealed June 1, 2023