Bill Summary – FastDemocracy

General Assembly                      Raised Bill No. 135
       February Session, 2020               LCO No. 1438
     Referred to Committee on GENERAL LAW
     Introduced by:
       (GL)
 AN ACT CONCERNING REVISIONS TO PHARMACY AND DRUG
 CONTROL STATUTES.
 Be it enacted by the Senate and House of Representatives in General
 Assembly convened:
       Section 1. Section 21a-319 of the general statutes is repealed and the
    following is substituted in lieu thereof (Effective October 1, 2020):
      (a) No certificate of registration shall be issued, maintained or
   renewed under this chapter unless or until the applicant has furnished
   proof satisfactory to the Commissioner of Consumer Protection that he
   or she is licensed or duly authorized to practice his or her profession by
   the appropriate state licensing board, commission or registration
   agency; or, in the case of a hospital or other institution, by the
   appropriate state agency having jurisdiction over the licensure,
   registration or approval of such establishment.
      (b) The Commissioner of Consumer Protection may change the status
   of a controlled substance registration to inactive for any practitioner
   who fails to maintain a license, registration or approval of a license to
   practice his or her medical profession for a period longer than ninety
   days. Such change in license status shall not be considered disciplinary
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 and the registration shall be reinstated without additional fee, if the
 practitioner restores his or her license, registration or approval to
 practice his or her profession with the Department of Public Health or
 associated board or commission, and the reinstatement occurs prior to
 the expiration of the controlled substance registration.
    Sec. 2. (NEW) (Effective from passage) (a) For purposes of this section,
 "epinephrine auto injector" means a prefilled auto injector or similar
 automatic injectable equipment used to deliver epinephrine in a
 standard dose for emergency first aid response to allergic reactions.
   (b) A pharmacist, in his or her professional discretion, may issue a
 prescription for an epinephrine auto injector under the following
 conditions:
    (1) The pharmacist identifies that the patient requesting such
 prescription has previously received an epinephrine auto injector by
 prescription from another pharmacy;
    (2) The pharmacist identifies the patient's current medical provider;
    (3) The pharmacist informs the patient's current medical provider of
 the issuance of the prescription not later than seventy-two hours after
 such issuance, by either phone, facsimile or electronic transmission;
    (4) The prescription issued by the pharmacist is for not more than
 two epinephrine auto injectors; and
     (5) The prescription issued by the pharmacist does not have any
 refills.
    (c) Nothing in this section shall prevent a pharmacist from verifying
 a previous prescription at any pharmacy in any part of the United States,
 including any state, district, commonwealth, territory or insular
 possession thereof, or any area subject to the legal authority of the
 United States of America.
   Sec. 3. Subsection (f) of section 20-633b of the 2020 supplement to the
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 general statutes is repealed and the following is substituted in lieu
 thereof (Effective from passage):
    (f) (1) If a sterile compounding pharmacy plans to remodel [a
 pharmacy clean room within the sterile compounding facility,] any area
 utilized for the compounding of sterile pharmaceuticals or adjacent
 space, relocate [a pharmacy clean room within the facility] any space
 utilized for the compounding of sterile pharmaceuticals or upgrade or
 conduct a nonemergency repair to the heating, ventilation, air
 conditioning or primary or secondary engineering controls for [a
 pharmacy clean room within the facility] any space utilized for the
 compounding of sterile pharmaceuticals, the sterile compounding
 pharmacy shall notify the Department of Consumer Protection, in
 writing, not later than [ten] sixty days prior to commencing such
 remodel, relocation, upgrade or repair. Such written notification shall
 include a plan for such remodel, relocation, upgrade or repair and such
 plan shall be subject to department review and approval. If a sterile
 compounding pharmacy makes an emergency repair, the sterile
 compounding pharmacy shall notify the department of such emergency
 repair, in writing, [as soon as possible] not later than twenty-four hours
 after such repair is commenced.
    (2) If the USP chapters require sterile recertification after such
 remodel, relocation, upgrade or repair, the sterile compounding
 pharmacy shall provide a copy of its sterile recertification to the
 Department of Consumer Protection not later than five days after the
 sterile recertification approval. The recertification shall only be
 performed by an independent licensed environmental monitoring
 entity.
    Sec. 4. Subsection (d) of section 20-614 of the 2020 supplement to the
 general statutes is repealed and the following is substituted in lieu
 thereof (Effective from passage):
    (d) Prior to or simultaneous with the dispensing of a drug, [pursuant
 to subsection (b) of this section,] a pharmacist or other employee of the
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 pharmacy shall, whenever practicable, offer for the pharmacist to
 discuss the drug to be dispensed and to counsel the patient on the usage
 of the drug, except when the person obtaining the prescription is other
 than the person named on the prescription form or electronic record or
 the pharmacist determines it is appropriate to make such offer in
 writing. Any such written offer shall include an offer to communicate
 with the patient either in person at the pharmacy or by telephone.
    Sec. 5. Section 21a-249 of the general statutes is repealed and the
 following is substituted in lieu thereof (Effective from passage):
    (a) All prescriptions for controlled drugs shall include (1) the name
 and address of the patient, or the name and address of the owner of an
 animal and the species of the animal, (2) whether the patient is an adult
 or a child, or his specific age, (3) the compound or preparation
 prescribed and the amount thereof, (4) directions for use of the
 medication, (5) the name and address of the prescribing practitioner, (6)
 the date of issuance, and (7) the Federal Registry number of the
 practitioner. No prescription blank containing a prescription for a
 schedule II substance shall contain more than one prescription. No
 prescription or order for a controlled substance issued by a practitioner
 to an inanimate object or thing shall be considered a valid prescription
 within the meaning of this chapter.
    (b) Each prescribing practitioner, as defined in section 20-14c, who
 the Department of Consumer Protection authorizes to prescribe
 controlled substances, within the scope of practice of his or her license,
 shall electronically transmit the controlled substance prescription to a
 pharmacy. Electronically transmitted prescriptions shall be promptly
 printed out in hardcopy or created as an electronic record and filed by
 the prescriber. Electronically transmitted prescriptions shall be
 consistent with the requirements of the federal Controlled Substances
 Act, 21 USC 801, as amended from time to time. All records shall be kept
 on file for three years at the premises of the licensed practitioner and
 maintained in such form as to be readily available for inspection by the
 commissioner, his or her authorized agent or other persons, as
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 authorized in section 21a-265, at reasonable times. For purposes of this
 subsection and subsections (c), (d) and (e) of this section, the term
 "electronically transmit" means to transmit by computer modem or
 other similar electronic device.
    (c) A licensed practitioner shall not be required to electronically
 transmit a prescription when:
    (1) Electronic transmission is not available due to a temporary
 technological or electrical failure. In the event of a temporary
 technological or electrical failure, the practitioner shall, without undue
 delay, reasonably attempt to correct any cause for the failure that is
 within his or her control. A practitioner who issues a prescription, but
 fails to electronically transmit the prescription, as permitted by this
 subsection, shall document the reason for the practitioner's failure to
 electronically transmit the prescription in the patient's medical record
 as soon as practicable, but in no instance more than seventy-two hours
 following the end of the temporary technological or electrical failure
 that prevented the electronic transmittal of the prescription. For
 purposes of this subdivision, "temporary technological or electrical
 failure" means failure of a computer system, application or device or the
 loss of electrical power to such system, application or device, or any
 other service interruption to such system, application or device that
 reasonably prevents the practitioner from utilizing his or her certified
 application to electronically transmit the prescription in accordance
 with subsection (b) of this section;
     (2) The practitioner reasonably determines that it would be
 impractical for the patient to obtain substances prescribed by an
 electronically transmitted prescription in a timely manner and that such
 delay would adversely impact the patient's medical condition, provided
 if such prescription is for a controlled substance, the quantity of such
 controlled substance does not exceed a five-day supply for the patient,
 if the controlled substance was used in accordance with the directions
 for use. A practitioner who issues a prescription, but fails to
 electronically transmit the prescription, as permitted by this subsection,
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 shall document the reason for the practitioner's failure to electronically
 transmit the prescription in the patient's medical record;
    (3) The prescription is to be dispensed by a pharmacy located outside
 this state. A practitioner who issues a prescription, but fails to
 electronically transmit the prescription, as permitted by this subsection,
 shall document the reason for the practitioner's failure to electronically
 transmit the prescription in the patient's medical record;
    (4) Use of an electronically transmitted prescription may negatively
 impact patient care, such as a prescription containing two or more
 products to be compounded by a pharmacist, a prescription for direct
 administration to a patient by parenteral, intravenous, intramuscular,
 subcutaneous or intraspinal infusion, a prescription that contains long
 or complicated directions, a prescription that requires certain elements
 to be included by the federal Food and Drug and Administration, or an
 oral prescription communicated to a pharmacist by a health care
 practitioner for a patient in a chronic and convalescent nursing home,
 licensed pursuant to chapter 368v; or
    (5) The practitioner demonstrates, in a form and manner prescribed
 by the commissioner, that such practitioner does not have the
 technological capacity to issue electronically transmitted prescriptions.
 For the purposes of this subsection, "technological capacity" means
 possession of a computer system, hardware or device that can be used
 to electronically transmit controlled substance prescriptions consistent
 with the requirements of the federal Controlled Substances Act, 21 USC
 801, as amended from time to time. The provisions of this subdivision
 shall not apply to a practitioner when such practitioner is prescribing as
 a telehealth provider, as defined in section 19a-906, pursuant to
 subdivision (2) of subsection (c) of said section.
    (d) Any prescription issued in a form other than an electronically
 transmitted prescription pursuant to subsection (c) of this section may
 be issued as a written order or, to the extent permitted by the federal
 Controlled Substance Act, 21 USC 801, as from time to time amended,
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 as an oral order or transmitted by facsimile machine. Such oral order or
 order transmitted by facsimile machine shall be promptly reduced to
 writing on a prescription blank or a hardcopy printout or created as an
 electronic record and filed by the pharmacist filling it. No duplicate,
 carbon or photographic copies and no printed or rubber-stamped orders
 shall be considered valid prescriptions within the meaning of this
 chapter.
    (e) Prescriptions for schedule II substances shall be electronically
 transmitted by the prescribing practitioner at the time of issuance and
 previously signed orders for such schedule II substances shall not be
 considered valid prescriptions within the meaning of this chapter. No
 practitioner shall prescribe, dispense or administer schedule II
 sympathomimetic amines as anorectics, except as may be authorized by
 regulations adopted by the Departments of Public Health and
 Consumer Protection acting jointly. To the extent permitted by the
 federal Controlled Substances Act, 21 USC 801, as from time to time
 amended, in an emergency, the dispensing of schedule II substances
 may be made upon the oral order of a prescribing registrant known to
 or confirmed by the filling pharmacist. The filling pharmacist shall
 promptly reduce such oral order to writing on a prescription blank,
 provided such oral order shall be confirmed by the proper completion
 and mailing or delivery of a prescription prepared by the prescribing
 registrant to the pharmacist filling such oral order within seventy-two
 hours after the oral order has been given. Such prescription of the
 registrant shall be affixed to the temporary prescription prepared by the
 pharmacist and both prescriptions shall be maintained on file as
 required in this chapter. The Department of Public Health and the
 Department of Consumer Protection, acting jointly, may adopt
 regulations, in accordance with chapter 54, allowing practitioners to
 prescribe, dispense or administer schedule II sympathomimetic amines
 as anorectics under certain specific circumstances. Nothing in this
 subsection shall be construed to require a licensed pharmacist to
 determine the diagnosis of a patient prior to dispensing a prescription
 for such substances to a patient.
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    (f) All prescriptions for controlled substances shall comply fully with
 any additional requirements of the federal food and drug laws, the
 federal Controlled Substances Act, and state laws and regulations
 adopted under this chapter.
   (g) Repealed by P.A. 82-419, S. 46, 47.
    (h) Except when dispensed directly by a practitioner, other than a
 pharmacy, to an ultimate user, a controlled substance included in
 schedule III or IV, which is a prescription drug as determined under
 federal food and drug laws, shall not be dispensed without a written,
 electronically transmitted or oral prescription of a practitioner. The
 prescription shall not be filled or refilled more than six months after the
 date thereof or be refilled more than five times, unless renewed by the
 practitioner.
    (i) A controlled substance included in schedule V shall not be
 distributed or dispensed other than for a medical purpose.
    (j) A pharmacy may sell and dispense controlled substances upon the
 prescription of a prescribing practitioner, as defined in subdivision (22)
 of section 20-571.
     (k) Pharmacies shall file filled prescriptions for controlled substances
 separately from other prescriptions. All schedule II prescriptions shall
 be filed in a separate file or in an electronic file. All schedule III, IV and
 V prescriptions shall be filed in another separate file or in an electronic
 file, except as otherwise provided for in regulations adopted pursuant
 to section 21a-243, 21a-244 or 21a-244a. All written controlled substance
 prescriptions shall, immediately upon filling, be filed chronologically
 and consecutively.
     (l) Any pharmacy may transfer an unfilled prescription for a schedule
 II, III, IV, or V controlled substance that was electronically transmitted
 consistent with the federal Controlled Sub