Substitute Senate Bill No. 202
Public Act No. 24-80
AN ACT CONCERNING THE DEPARTMENT OF CONSUMER
PROTECTION'S RECOMMENDATIONS REGARDING
PRESCRIPTION DRUG CONTROL.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. Subsection (a) of section 21a-65 of the 2024 supplement to
the general statutes is repealed and the following is substituted in lieu
thereof (Effective from passage):
(a) A licensed manufacturer or licensed wholesaler may sell
hypodermic needles and syringes only to the following: (1) To a licensed
manufacturer, licensed wholesaler or licensed pharmacy; (2) to [a] an
advanced practice registered nurse, dentist, embalmer, optometrist,
physician, [dentist,] physician assistant, podiatrist, scientific
investigator or veterinarian [, embalmer, podiatrist or scientific
investigator] licensed to practice in this state; (3) to a person in charge of
a care-giving institution, as defined in section 20-571, incorporated
college or scientific institution, but only for use by or in such care-giving
institution, college or institution for medical or scientific purposes; (4)
to a person in charge of a licensed or registered laboratory, but only for
use in that laboratory for scientific and medical purposes; (5) to a farmer
but only for use on the farmer's own animals or poultry; (6) to a business
authorized in accordance with the regulations adopted under section Substitute Senate Bill No. 202
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21a-66 to purchase hypodermic needles and syringes but only for
legitimate industrial or medical use within that business; and (7) to a
syringe services program established pursuant to section 19a-124.
Sec. 2. Section 21a-70h of the 2024 supplement to the general statutes
is repealed and the following is substituted in lieu thereof (Effective from
passage):
For the purposes of this section and sections 21a-70i to 21a-70k, as
amended by this act:
(1) "Commissioner" means the Commissioner of Consumer
Protection or the commissioner's authorized representative;
(2) "Contact" means any communication transmitted in person or by
telephone, electronic mail, text message or other electronic means
between a pharmaceutical representative and a prescribing practitioner
or pharmacist, to promote or provide information relating to a legend
drug;
(3) "Department" means the Department of Consumer Protection;
(4) "Legend drug" has the same meaning as provided in section 20-
571;
(5) "Pharmaceutical manufacturer" (A) means a [(A)] (i) person,
whether within or without the boundaries of the state of Connecticut,
that (I) produces, prepares, cultivates, grows, propagates, compounds,
converts or processes a drug, [device or cosmetic,] directly or indirectly,
by extraction from substances of natural origin, by means of chemical
synthesis or by a combination of extraction and chemical synthesis, or
[that] (II) packages, repackages, labels or relabels a drug container under
such manufacturer's own trademark or label, or any other trademark or
label, [or a drug, device or cosmetic] for the purpose of selling the drug,
[device or cosmetic,] or [(B)] (ii) sterile compounding pharmacy, as Substitute Senate Bill No. 202
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defined in section 20-633b that dispenses sterile pharmaceuticals
without a prescription or a patient-specific medical order intended for
use in humans, and (B) includes, but is not limited to, a virtual
manufacturer, as defined in section 20-571;
[(6) "Pharmaceutical manufacturer" includes a virtual manufacturer,
as defined in section 20-571;]
[(7)] (6) "Pharmaceutical marketing firm" means a pharmaceutical
manufacturer that employs or compensates pharmaceutical
representatives;
[(8)] (7) "Pharmaceutical representative" means any person,
including, but not limited to, a sales representative, who markets,
promotes or provides information regarding a legend drug for human
use to a prescribing practitioner and is employed or compensated by a
pharmaceutical manufacturer;
[(9)] (8) "Pharmacist" has the same meaning as provided in section 20-
571; and
[(10)] (9) "Prescribing practitioner" has the same meaning as provided
in section 20-571.
Sec. 3. Section 21a-70i of the 2024 supplement to the general statutes
is repealed and the following is substituted in lieu thereof (Effective from
passage):
(a) On and after October 1, 2023, a pharmaceutical manufacturer that
employs [an individual to perform the duties of] a pharmaceutical
[sales] representative shall register annually with the department as a
pharmaceutical marketing firm, in a form and manner prescribed by the
commissioner. No pharmaceutical manufacturer shall authorize an
individual to perform [such] the duties of a pharmaceutical
representative on such manufacturer's behalf unless such manufacturer Substitute Senate Bill No. 202
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has obtained a pharmaceutical marketing firm registration from the
department pursuant to this section. Registrations issued pursuant to
this section shall expire annually on June thirtieth.
(b) The nonrefundable fee for registration as a pharmaceutical
marketing firm and for annual renewal of such registration shall be one
hundred fifty dollars. Any pharmaceutical marketing firm that fails to
renew its registration on or before June thirtieth shall pay a late fee of
one hundred dollars for each year that such firm did not renew, in
addition to the annual renewal fee required under this section.
(c) On the date of its initial registration, and annually thereafter, each
pharmaceutical marketing firm shall provide to the department a list of
all [individuals] pharmaceutical representatives employed or
compensated by such firm. [as a pharmaceutical sales representative.]
Each pharmaceutical marketing firm shall notify the department, in a
form and manner prescribed by the commissioner, of each individual
who is no longer employed or compensated as a pharmaceutical [sales]
representative or who was hired or compensated as a pharmaceutical
representative after the date on which such firm provided such annual
list, not later than two weeks after such individual leaves employment
or was hired or otherwise compensated.
(d) The department shall prominently post on its Internet web site the
most recent list provided by each pharmaceutical marketing firm
pursuant to subsection (c) of this section.
(e) Any person who is not identified to the department pursuant to
subsection (c) of this section shall not perform the duties of a
pharmaceutical [sales] representative on behalf of the pharmaceutical
marketing firm. [for any prescribing practitioner in this state.]
(f) Not later than July 1, 2024, and annually thereafter, each
pharmaceutical marketing firm shall provide the commissioner with the Substitute Senate Bill No. 202
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following information regarding the performance for the previous
calendar year of each of its pharmaceutical [sales] representatives
identified to the department pursuant to subsection (c) of this section at
any time during the previous calendar year, in a form and manner
prescribed by the commissioner:
(1) The aggregate number of contacts such pharmaceutical [sales]
representative had with prescribing practitioners and pharmacists;
(2) The specialty of [each] such prescribing practitioner and each
pharmacist with whom such pharmaceutical [sales] representative
made contact;
(3) Whether product samples, materials or gifts of any value were
provided to a prescribing practitioner or such practitioner's staff in a
prescribing practitioner's office or to a pharmacist; and
(4) An aggregate report of all free samples, by drug name and
strength, in a form and manner prescribed by the commissioner.
(g) The department shall annually [analyze the information
submitted pursuant to this section and] compile a report on the activities
of pharmaceutical [sales representatives] marketing firms in the state.
Not later than December [1] 31, 2024, and annually thereafter, the
department shall post such report on its Internet web site and submit
such report to the Secretary of the Office of Policy and Management.
Sec. 4. Section 21a-70j of the 2024 supplement to the general statutes
is repealed and the following is substituted in lieu thereof (Effective from
passage):
Each pharmaceutical marketing firm that employs or compensates a
pharmaceutical representative who is engaged in marketing, promoting
or providing information regarding a legend drug [marketing] for
human use in this state shall [disclose] ensure that such pharmaceutical Substitute Senate Bill No. 202
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representative discloses, in writing, to a prescribing practitioner or
pharmacist, [at the] each time [of each] such pharmaceutical
representative makes contact with [such] the prescribing practitioner or
pharmacist: [, the following information:]
(1) The list price of a legend drug when such pharmaceutical
representative provides information concerning [such] the legend drug
to [the] such prescribing practitioner or pharmacist based on the dose
and quantity of such legend drug as described in the medication
package insert; and
(2) Information on the variation efficacy of the legend drug marketed
to different racial and ethnic groups, if such information is available.
Sec. 5. Section 19a-17d of the 2024 supplement to the general statutes
is repealed and the following is substituted in lieu thereof (Effective from
passage):
If a [pharmacist or] health care professional who is currently licensed
or was previously licensed in another state or jurisdiction is subject to
automatic reciprocal discipline for a disciplinary action in such state or
jurisdiction, such automatic reciprocal discipline shall be automatically
rescinded and shall not be entered into the licensing record of the
[pharmacist or] health care professional if the discipline was based
solely on the termination of pregnancy under conditions that would not
violate the general statutes or the regulations of Connecticut state
agencies. The provisions of this section shall not preclude or affect the
ability of an agency or board of the state to seek or impose any discipline
pursuant to the general statutes against a [pharmacist or other] health
care professional licensed by the state.
Sec. 6. Subsection (a) of section 21a-70k of the 2024 supplement to the
general statutes is repealed and the following is substituted in lieu
thereof (Effective from passage): Substitute Senate Bill No. 202
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(a) The commissioner may (1) refuse to authorize the issuance or
renewal of a registration to operate as a pharmaceutical marketing firm,
(2) revoke, suspend or place conditions on a registration to operate as a
pharmaceutical marketing firm, and (3) assess a penalty of up to one
thousand dollars for each violation of any provision of section 21a-70i,
as amended by this act, or 21a-70j, as amended by this act, or take other
action permitted by [subdivision (7) of subsection (a) of section 21a-7]
section 21a-11, if the applicant or holder of the registration fails to
comply with the requirements set forth in section 21a-70i, as amended
by this act, or 21a-70j, as amended by this act.
Sec. 7. Section 21a-322 of the general statutes is repealed and the
following is substituted in lieu thereof (Effective from passage):
(a) The [commissioner] Commissioner of Consumer Protection may
suspend, revoke or refuse to renew a registration, place a registration on
probation, place conditions on a registration and assess a civil penalty
of not more than one thousand dollars per violation of this chapter, for
sufficient cause. Any of the following shall be sufficient cause for such
action by the commissioner: (1) The furnishing of false or fraudulent
information in any application filed under this chapter; (2) conviction of
a crime under any state or federal law relating to the registrant's
profession, controlled substances or drugs or fraudulent practices,
including, but not limited to, fraudulent billing practices; (3) failure to
maintain effective controls against diversion of controlled substances
into other than duly authorized legitimate medical, scientific, or
commercial channels; (4) the suspension, revocation, expiration or
surrender of the practitioner's federal controlled substance registration;
(5) prescribing, distributing, administering or dispensing a controlled
substance in schedules other than those specified in the practitioner's
state or federal registration or in violation of any condition placed on
the practitioner's registration; (6) suspension, revocation, expiration,
surrender or other disciplinary action taken against any professional Substitute Senate Bill No. 202
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license or registration held by the practitioner; (7) abuse or excessive use
of drugs; (8) possession, use, prescription for use or distribution of
controlled substances or legend drugs, except for therapeutic or other
proper medical or scientific purpose; (9) a practitioner's failure to
account for disposition of controlled substances as determined by an
audit of the receipt and disposition records of said practitioner; (10)
failure to keep records of medical evaluations of patients and all
controlled substances dispensed, administered or prescribed to patients
by a practitioner; (11) failure to establish and implement administrative
safeguards for the protection of electronic protected health information
pursuant to 45 CFR 164.308, as amended from time to time; and (12)
breach of any such safeguards by a prescribing practitioner's authorized
agent.
(b) If a practitioner dispenses, administers or prescribes any
controlled substance to a patient, the practitioner shall make available
to the Department of Consumer Protection, for inspection by the
department, records of medical evaluations associated with dispensing,
administering or prescribing such controlled substance. Such records
shall be confidential and not be subject to disclosure under the Freedom
of Information Act, as defined in section 1-200. The department may
inspect such records solely for the purpose of investigating any violation
or suspected violation, or enforcing any provision, of this chapter or any
regulation promulgated under this chapter. Nothing in this subsection
shall be construed to require disclosure of any substance abuse
treatment record that is protected from disclosure under 42 USC 290dd-
2, as amended from time to time, or other applicable federal law.
Sec. 8. Subparagraphs (A) and (B) of subdivision (10) of subsection (j)
of section 21a-254 of the general statutes are repealed and the following
is substituted in lieu thereof (Effective from passage):
(10) (A) A prescribing practitioner may designate an authorized
agent to review the electronic prescription drug monitoring program Substitute Senate Bill No. 202
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and patient controlled substance prescription information on behalf of
the prescribing practitioner. The prescribing practitioner shall ensure
that any authorized agent's access to such program and patient
controlled substance prescription information is limited to the purposes
described in this section and occurs in a manner that protects the
confidentiality of information that is accessed through such program.
The prescribing practitioner and any authorized agent shall be subject
to the provisions of 45 CFR 164.308, as amended from time to time,
concerning administrative safeguards for the protection of electronic
protected health information. A prescribing practitioner may be subject
to disciplinary action for acts of the authorized agent as provided in
subsection (a) of section 21a-322, as amended by this act.
(B) Notwithstanding the provisions of subparagraph (A) of this
subdivision, a prescribing practitioner who is employed by or provides
professional services to a hospital shall, prior to designating an
authorized agent to review the electronic prescription drug monitoring
program and patient controlled substance prescription information on
behalf of the prescribing practitioner, (i) submit a request to designate
one or more authorized agents for such purposes and a written protocol
for oversight of the authorized agent or agents to the commissioner, in
the form and manner prescribed by the commissioner, and (ii) receive
the commissioner's approval to designate such authorized agent or
agents and of such written protocol. Such written protocol shall
designate either the hospital's medical director, a hospital department
head, who is a prescribing practitioner, or another prescribing
practitioner as the person responsible for ensuring that the authorized
agent's or agents' access to such program and patient controlled
substance prescription information is limited to the purposes described
in this section and occurs in a manner that protects the confidentiality
of information that is accessed through such program. A hospital
medical director, a hospital department head, who is a prescribing
practitioner, or another prescribing practitioner designated as the Substitute Senate Bill No. 202
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person responsible for overseeing an authorized agent's or agents'
access to such program and information in the written protocol
approved by the commissioner may be subject to disciplinary action for
acts of the authorized agent or agents as provided in subsection (a) of
section 21a-322, as amended by this act. The commissioner may inspect
hospital records to determine compliance with written protocols
approved in accordance with this section.