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OLR Bill Analysis
sSB 1102 (File 221, as amended by Senate "A")*
AN ACT CONCERNING PHARMACIES AND PHARMACISTS.
SUMMARY
This bill makes changes in the laws on pharmacists and consumer
access to medications. Specifically, it:
1. establishes a licensing process for institutional pharmacies
located in health care facilities (e.g., hospitals) to compound
sterile pharmaceuticals and sell them at retail;
2. allows pharmacists to order and administer tests for COVID-19,
HIV, and influenza;
3. allows pharmacists to prescribe and dispense HIV-related
prophylaxis if a patient tests negative after a pharmacist-
administered HIV test;
4. expands the vaccine types that pharmacists can administer and
allows pharmacy technicians to administer vaccines;
5. allows pharmacists to administer an epinephrine cartridge
injector to someone experiencing anaphylaxis;
6. allows pharmacies to operate mobile pharmacies in temporary
locations with the Department of Consumer Protection’s (DCP)
approval;
7. requires pharmacies to maintain a plan to manage unscheduled
closings and specifies actions that can and must be taken during
these closures;
8. requires DCP to adopt regulations on prescription pickup lockers
at pharmacies, but allows for their use before the regulations are 2023SB-01102-R01-BA.DOCX
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adopted under specified circumstances; and
9. requires the Department of Public Health (DPH) to establish and
contract for a statewide program providing HIV pre- and post-
exposure prophylaxis drug assistance, if there is specified
funding for it (in doing so, the bill replaces a current, narrower
program).
The bill also makes minor, technical, and conforming changes.
*Senate Amendment “A” (1) adds the provisions on pharmacy
technicians administering vaccines (§ 5) and the HIV prophylaxis drug
assistance program (§ 17); (2) makes various changes to the underlying
bill’s provisions on testing for COVID-19, influenza, and HIV and
prescribing HIV prophylaxis, including provisions on DCP’s
regulations and disclosure of test results; and (3) makes other minor
changes to the bill’s underlying provisions.
EFFECTIVE DATE: July 1, 2023, except the HIV prophylaxis drug
program provision is effective upon passage (§ 17).
§§ 1 & 6-16 — HEALTH CARE INSTITUTIONAL PHARMACIES’
STERILE COMPOUNDING
The bill establishes a process to allow institutional pharmacies
located in licensed health care facilities (“health care institutional
pharmacies”) to compound sterile pharmaceuticals for retail sale and
subjects them to the same requirements that apply to other retail
pharmacies compounding sterile pharmaceuticals. Under current law,
health care institutional pharmacies (1) are generally not licensed as
pharmacies and (2) do not compound sterile pharmaceuticals for retail
sale. The bill authorizes DCP to adopt regulations creating a class or
classes of pharmacy licenses specifically for health care institutional
pharmacies. It also explicitly authorizes health care institutions to apply
for a pharmacy license, subject to the same existing licensure
requirements as pharmacists and others applying for a license.
Sterile Compounding for Retail Sales
Under existing law, if a pharmacy licensee intends to compound 2023SB-01102-R01-BA.DOCX
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sterile pharmaceuticals, it must seek DCP’s approval by applying for an
addendum to its pharmacy license application and submitting to a DCP
inspection. The bill requires a health care institutional pharmacy that
wants to sell compounded sterile pharmaceuticals at retail to obtain a
pharmacy license and similarly apply for an addendum and undergo an
inspection.
By deeming health care institutional pharmacies that compound
sterile pharmaceuticals for retail sale “sterile compounding
pharmacies,” the bill also subjects them to the same requirements that
apply to other retail pharmacies (e.g., required notices to DCP),
including requirements adopted by regulation.
Compounding for Non-Retail Uses
Under current law, if an institutional pharmacy within a licensed
health care facility compounds sterile pharmaceuticals, it does not need
to apply for DCP approval, but like other sterile compounding
pharmacies, it must comply with applicable state, federal, and U.S.
Pharmacopeia standards, unless it receives a temporary extension to do
so. The bill generally eliminates provisions in law regulating these
institutional pharmacies’ compounding of sterile pharmaceuticals and
specifies that the law on retail sterile compounding pharmacies does not
prohibit a licensed hospital from compounding sterile pharmaceuticals
for its patients consistent with federal law. In doing so, it also eliminates
provisions specifically requiring institutional pharmacies to (1) prepare
and maintain a policy and procedure manual and (2) inform DCP which
pharmacist is responsible for overseeing the compounding of sterile
pharmaceuticals.
§§ 2 & 5 — EXPANDED SCOPE OF PR ACTICE
The bill expands pharmacists’ scope of practice by authorizing them
to (1) administer additional vaccines and epinephrine cartridge injectors
(§ 5); (2) order and administer COVID-19, HIV, and influenza related
tests (§ 2); and (3) prescribe HIV-related prophylaxis if an HIV test they
ordered and administered comes back negative (§ 2). It also allows
pharmacy technicians meeting certain criteria to administer the same
vaccines as pharmacists (§ 5). 2023SB-01102-R01-BA.DOCX
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Pharmacists’ Administration of Vaccines
By law, pharmacists who comply with DCP regulations on vaccine
administration training may administer to adults any approved vaccine
on the Centers for Disease Control and Prevention’s (CDC) adult
immunization schedule, if ordered by a health care provider. Currently,
for children ages 12-17, they may administer an influenza vaccine
ordered by a health care provider if they have the parent or guardian’s
consent. (Under temporary federal rules (see BACKGROUND),
pharmacists can also currently administer various vaccines to children
ages three and older.)
The bill permanently expands the types of vaccines pharmacists can
administer to people ages 12 or older. It also eliminates the requirement
that a pharmacist-administered vaccine only be administered if ordered
by a health care provider. Under the bill, vaccines must be administered
in compliance with DCP regulations and according to the
manufacturer’s package insert or a prescribing practitioner’s (e.g.,
doctor or APRN) orders. Specifically, the bill allows pharmacists to
additionally administer any vaccine:
1. on the adult immunization schedule and authorized by the U.S.
Food and Drug Administration (FDA) (current law only permits
administration of approved vaccines; the FDA sometimes issues
emergency authorizations for vaccines before full approval);
2. not on the adult immunization schedule but for which the
vaccine administration instructions are available on the CDC’s
website; or
3. prescribed by a prescribing practitioner for a specific patient.
Under the bill, pharmacists can administer vaccines to any patient
ages 18 or older. For patients who are ages 12-17, they may only do so
with (1) the consent of the patient’s parent, legal guardian, or other
person having legal custody or (2) proof that the patient is an
emancipated minor. The bill correspondingly aligns the law on
consenting to influenza vaccines for minors with these requirements. 2023SB-01102-R01-BA.DOCX
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Under the bill, before administering a vaccine, the pharmacist must
make a reasonable effort to review the patient’s vaccination history to
prevent a requested vaccine’s inappropriate use.
Under existing law, DCP must adopt regulations requiring that
pharmacists administering vaccines complete an immunization training
course. The bill correspondingly extends this training requirement to
pharmacists administering the additional vaccines the bill allows them
to administer.
Pharmacy Technicians’ Administration of Vaccines
The bill extends to registered and certified pharmacy technicians
authority to administer the same vaccines that pharmacists can
administer (see above). (Under temporary federal rules, pharmacy
technicians may already administer certain vaccines (see
BACKGROUND).)
Under the bill, a pharmacy technician can administer vaccines if the
technician:
1. successfully completes (a) a course, certified by the American
Council for Pharmacy Education, of hands-on training on vaccine
administration and (b) at least one hour of annual continuing
education on immunization;
2. received trained at their employing pharmacy on the process for
administering vaccines to patients and was evaluated by the
managing pharmacist (who must be authorized to administer
vaccines); and
3. only administers vaccines at the direction of the pharmacist on
duty.
The bill also specifies that each year, for the period beginning on
September 1 and ending the following March 31, a certified and
registered pharmacy technician does not count toward the minimum
pharmacist-to-technician ratio set in regulations if the technician is
authorized to administer vaccines under the bill and exclusively 2023SB-01102-R01-BA.DOCX
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performs duties related to administering vaccines during that period.
Pharmacists’ Administration of Epinephrine
If a pharmacist has taken the training required to administer a
vaccine (see above), the bill allows him or her to administer an
epinephrine cartridge injector to a patient reasonably believed, based on
the pharmacist’s knowledge and training, to be experiencing
anaphylaxis. This authorization applies regardless of whether the
patient has a prescription for an epinephrine cartridge injector.
The pharmacist or his or her designee must call 9-1-1 either before or
immediately after administering the epinephrine cartridge injector. The
pharmacist must also document the date, time, and circumstances in
which he or she administered it, and maintain the documentation for at
least three years.
COVID-19, HIV, and Influenza Testing by Pharmacists
COVID-19 and Influenza Testing. Under temporary federal rules,
pharmacists can currently order and administer COVID-related tests.
The bill permanently allows pharmacists to order and administer
COVID-19 and influenza related tests if they are employed by a:
1. hospital or
2. pharmacy that has a DPH-approved complete clinical laboratory
improvement amendment application for certification for a
COVID-19 or influenza related test.
They may do so for any patient aged 18 or older. For patients who are
at least age 12, but younger than 18, they may only do so with (1) the
consent of the patient’s parent, legal guardian, or other person having
legal custody or (2) proof that the patient is an emancipated minor. The
bill specifies that pharmacists working outside a hospital must comply
with any training requirements DCP sets.
HIV Testing. After DCP adopts regulations on HIV testing and
prophylaxis (see below), pharmacists may also order and administer
HIV-related tests, under substantially similar conditions that apply to 2023SB-01102-R01-BA.DOCX
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COVID-19 and influenza testing (e.g., they must work for a qualifying
pharmacy and cannot test children under age 12). The bill specifies that
pharmacists working outside a hospital must comply with any training
requirements set in regulation.
Pharmacists Prescribing HIV Prophylaxis
If a pharmacist orders and administers an HIV-related test and the
result is negative, the pharmacist may prescribe and dispense to the
patient pre- or post-exposure HIV-related prophylaxis. The pharmacist
may do so only if (1) he or she completed the training required by
regulations (see below), (2) the patient meets the criteria on the package
insert, and (3) prophylaxis is prescribed and dispensed in conformity
with the state’s pharmacy laws and related regulations.
Disclosure of Test Results and Prophylaxis Prescriptions
Under the bill, when pharmacists administer a COVID-19, influenza,
or HIV test, they must give the patient the test results in writing and
maintain a record of them for at least three years. They must also notify
the (1) patient’s primary care provider, if the patient identifies one, and
(2) local health director for the area in which the patient lives and DPH,
in the same way as required for reportable diseases.
Pharmacists must also disclose the results to DCP’s commissioner or
his designee, upon request. Similarly, if a pharmacist prescribes HIV-
related prophylaxis, DCP may request a copy of the test results,
prescription records, and any other documents the commissioner
requires by regulations.
Confidentiality. The bill requires any information disclosed by a
pharmacist to DCP under the bill or related regulations to be kept
confidential, regardless of any conflicting provisions in the Freedom of
Information Act. The bill limits DCP’s use of the information to
performing its pharmacy law-related enforcement duties.
If DCP brings an enforcement action and in it uses any information
the bill makes confidential, the bill allows DCP to disclose it to the
parties to the action only if required by applicable law. Further 2023SB-01102-R01-BA.DOCX
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disclosure is prohibited, except to a tribunal, the Commission of
Pharmacy, an administrative agency, or the court with jurisdiction.
These entities must ensure that the information is subject to a qualified
protective order, as defined by the Health Insurance Portability and
Accountability Act (HIPAA) (i.e., ensure information cannot be used for
other purposes and must be returned or destroyed at the end of the
proceeding).
Regulations Related to Testing and HIV Prophylaxis Prescribing
The bill requires the DCP commissioner to adopt regulations to
implement the bill’s testing and prescribing authorizations. In doing so,
he must consult with the DPH commissioner, the Commission of
Pharmacy, a statewide professional society representing the interests of
physicians practicing medicine in Connecticut, and a statewide
organization representing the interests of health care professionals and
scientists specializing in the control and prevention of infectious
diseases. The regulations must:
1. ensure compliance with all applicable CDC guidance;
2. ensure that HIV-related prophylaxis is prescribed and dispensed
in accordance with its FDA approval;
3. establish permissible routes of administration;
4. establish prescription duration limits of up to 60 days for any pre-
exposure prophylaxis and 30 days for any post-exposure
prophylaxis;
5. specify how frequently a pharmacist must treat a patient and
when he or she must refer the patient to his or her primary care
provider or other identified health care provider;
6. specify circumstances in which a pharmacist must recommend
that a patient undergo screenings for sexually transmitted
infections other than HIV;
7. establish requirements on private areas for consultations 2023SB-01102-R01-BA.DOCX
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between pharmacists and patients;
8. establish training requirements on methods to obtain a patient’s
complete sexual history, delivering a positive HIV-related test
result to a patient, referring a patient who has tested positive for
HIV to available services, and using HIV-related prophylaxes for
patients who have tested negative;
9. identify qualifying training programs accredited by the CDC, the
Accreditation Council for Pharmacy Education, or another
appropriate national accrediting body; and
10. establish a control and reporting system.
§ 3 — OPERATING MOBILE PHARMACIES
The bill allows retail pharmacies to apply to DCP for permission to
operate a mobile pharmacy that (1) conducts temporary pharmacy
operations, vaccination events, or opioid antagonist training and
prescribing events or (2) offers pharmacy services to an underserved
community. DCP sets the application form and must approve it, in
writing, before a mobile pharmacy can operate. DCP may inspect the
mobile pharmacy as needed, including before it begins operations.
With the advice and consent of the Commission of Pharmacy, the
DCP commissioner may adopt regulations to implement the bill’s
mobile pharmacy provisions.
Operational Requirements
Unless DCP approves an exception, mobile pharmacies cannot (1)
operate in one place for more than seven consecutive days, (2) operate
for more than 14 days within a five-mile radius of the prior mobile
pharmacy location, or (3) serve as an overnight storage space for drugs.
Mobile pharmacies must be supervised by a pharmacist. The
pharmacy that operates them must:
1. keep records indicating which drugs it removes from the
pharmacy premises for use in the mobile pharmacy and which 2023SB-01102-R01-BA.DOCX
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ones it dispenses;
2. update the pharmacy’s records within 24 hours after dispensing
a drug through a mobile pharmacy;
3. inventory and return unused drugs to the pharmacy premises by
the close of business each day unless DCP waives the bill’s
prohibition on storing drugs in the mobile pharmacy overnight;
4. store drugs in a way that prevents diversion, and meets the
storage conditions specified by the drugs’ manufacturers;
5. establish and maintain a patient communication plan to ensure
patient access to prescription refills if the mobile pharmacy is
unavailable; and
6. store and handle controlled substances in conformity with DCP
regulations, if the federal Drug Enforcement Administration
allows mobile pharmacies to store controlled substances.
DCP may order a mobile pharmacy to close if it determines that (1) it
failed to comply with the bill’s requirements or existing requirements
on practicing pharmacy, drugs, or devices; (2) it is unsafe to store drugs
in it or dispense them from it; or (3) there is insufficient security.
§ 4 — UNSCHEDULED PH ARMACY CLOSURES AND
PRESCRIPTION PICKUP LOCKERS
The bill creates rules for pharmacies when they face an unscheduled
closure (which the bill does not define), including customer and
prescriber notification and planning requirements. It requires DCP to
adopt regulations to (1) implement the bill’s provisions on unscheduled
pharmacy closures and (2) allow and regulate prescription pickup
lockers (see below).
Plan’s Contents
The bill requires retail pharmacies to have a plan to manage
unscheduled closings and annually review and, if necessary, update it.
The plan must also be given to and reviewed with all pharmacy
personnel annually. 2023SB-01102-R01-BA.DOCX
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The plan must include the name of:
1. the person responsible for notifying the Commission of
Pharmacy about an unscheduled closing;
2. the person responsible for updating the operation hours in the
pharmacy’s electronic record system so that it will not accept
electronically transmitted prescriptions during the unscheduled
closing;
3. the person responsible for updating the pharmacy’s telephone
system during an unscheduled closing to (a) ensure orally
transmitted prescriptions are not accepted during the
unscheduled closing and (b) provide a message that alerts
patients to the closure and their ability to obtain their
prescriptions from a nearby pharmacy;
4. all pharmacies located within a two-mile radius, or the next
closest pharmacy if there is no pharmacy within that radius; and
5. the person responsible for posting a sign stating the closure’s
duration at the pharmacy’s entrance and at each entrance of the
structure containing it, if any.
Requirements During Unscheduled Closing
When a pharmacy experiences an unscheduled closing, the
pharmacist manager of the pharmacy or, if the pharmacy operates more
than five pharmacy locations in Connecticut, the pharmacy district
manager must:
1. modify the pharmacy’s operating hours in its pharmacy’s
electronic record system to prevent accepting electronically
transmitted prescriptions during the unscheduled closing;
2. adjust the pharmacy’s telephone system to prevent accepting
orally transmitted prescriptions during the unscheduled closing;
3. provide a telephone system message alert to patients notifying
them that the pharmacy is closed and they may obtain 2023SB-01102-R01-BA.DOCX
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medications from a nearby pharmacy;
4. post signs at the pharmacy’s entrance, and at each entrance of the
structure if the pharmacy is located within another structure,
stating that the pharmacy is closed, the duration of the
unscheduled closing, and providing (a) a list of all pharmacies
within a two-mile radius or (b) the next closest pharmacy if there
is no pharmacy within a two-mile radius; and
5. on the request of another pharmacy, transfer a prescription and
reverse any third-party payor claims associated with the already
dispensed prescription.
Under the bill, the “pharmacy district manager” is the person who
supervises at least three Connecticut pharmacies and is responsible for
their activities, including staffing, payroll, and hiring.
Dispensing Prescriptions Awaiting Pickup at a Closed Pharmacy
If a pharmacy verifies that another pharmacy is experiencing an
unscheduled closing, on a patient’s request, it may dispense a
prescription that is dispensed and waiting for pickup at the closed
pharmacy. It may do so using information from the closed pharmacy,
the electronic prescription drug monitoring program, or another source
that the pharmacist believes is reasonably accurate. If a prescription is
dispensed under these circumstances, the dispensing pharmacy must
contact the closed pharmacy within 24 hours after it reopens to transfer
the prescription.
Under the bill, these transfers are subject to existing requirements for
prescription transfers, which generally require the:
1. transferring pharmacist to cancel the original prescription in his
or her records and indicate in the records the pharmacy to which
the prescription is transferred and transfer date and
2. receiving pharmacist to indicate in his or her records the (a)
transfer and the transferring pharmacy and pharmacist’s names,
(b) original prescription’s issue date and number, (c) date the 2023SB-01102-R01-BA.DOCX
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original prescription was first dispensed, (d) number of refills
authorized by the original prescription and complete refill record
as of the transfer date, and (e) number of valid refills remaining
as of the transfer date.
The bill requires the pharmacy that experienced the unscheduled
closure to give the dispensing pharmacy all information necessary for
the transfer. It must also reverse any third-party payor claims associated
with the transferred prescription within 24 hours after it reopens.
Secure Prescription Pickup Lockers
The bill requires DCP to adopt regulations on unscheduled pharmacy
closures and include provisions on placing a “secured container” at a
pharmacy that allows patients to collect dispensed prescriptions
(prescription pickup lockers).
Before adopting the regulations, DCP may temporarily allow the use
of prescription pickup lockers. Pharmacies must first submit protocols
on using these lockers to DCP for its written approval. They may only
be approved if the lockers:
1. (a) weigh more than 750 pounds or are affixed to the pharmacy
building’s structure and (b) are located immediately adjacent to
the pharmacy’s location;
2. limit access to authorized pharmacy personnel and individuals
retrieving prescriptions with a unique identification system;
3. are under constant video surveillance;
4. can maintain a record of all products placed inside and the date
and time each individual prescription is accessed; and
5. comply with any other DCP protocols ensuring patient
confidentiality, protecting public health and safety, and
preventing prescription diversion.
§ 17 — HIV PROPHYLAXIS DRUG ASSISTANCE PROGRAM
The bill requires DPH to establish and contract for a statewide 2023SB-01102-R01-BA.DOCX
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program providing HIV pre- and post-exposure prophylaxis (PrEP and
PEP) drug assistance, as long as there is at least $25,000 of annual AIDS
service funding for it. The bill’s program replaces a current, narrower
program providing $25,000 in annual PEP funding for certain under- or
uninsured sexual assault victims.
The new program must give financial assistance to people at risk of
acquiring HIV to help pay for these medications. This may include,
among other things, (1) payments for copayments, coinsurance, or other
out-of-pocket costs and (2) up to full cost payments toward deductibles
for people who are underinsured and for whom the program is the
payer of last resort.
DPH must give priority to people at increased risk of acquiring HIV
or who have had a recent exposure, but cannot purchase PrEP or PEP
medication and for whom the program is a payer of last resort.
Similar to the current program, medications funded under the bill
must be prescribed by a physician and consistent with the CDC’s
recommendations.
The bill allows the DPH commissioner to adopt implementing
regulations. She may also implement necessary policies and procedures
to administer the program, as long as she posts her intent to adopt
regulations in the eRegulations System within 20 days after their
implementation. The policies and procedures remain in effect until the
regulations are adopted.
BACKGROUND
Federal PREP Act and Administration of Vaccines
The federal Public Readiness and Emergency Preparedness Act
authorizes the federal Health and Human Services (HHS) secretary to
issue declarations protecting certain covered persons from liability
related to the administration or use of medical countermeasures (42
U.S.C. § 247d–6d). Under this authority, the HHS secretary issued
declarations authorizing (1) state-licensed pharmacists, under certain
criteria, to order and administer (a) vaccinations to minors ages three 2023SB-01102-R01-BA.DOCX
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and older and (b) COVID-19 tests and (2) pharmacy technicians to
administer certain vaccinations under a pharmacist’s supervision. (HHS
recently issued guidance stating that it plans to extend specified
authority under these provisions through 2024.)
PrEP and PEP
According to the CDC, PrEP is a way for people with substantial risk
of contracting HIV to lower that risk by taking specified medication as
either a daily pill or an injection every two months. When someone is
exposed to HIV these medications can prevent the virus from causing a
permanent infection.
PEP is the use of antiretroviral medications to lower the risk of
contracting HIV after a single high-risk potential exposure. For
maximum effectiveness, it should be taken as soon as possible after the
exposure and must be taken within 72 hours.
Related Bills
sSB 1068 (File 432), favorably reported by the Public Health
Committee, contains identical provisions on a statewide program
providing HIV pre- and post-exposure prophylaxis drug assistance.
sHB 6768 (File 215), favorably reported by the General Law
Committee, (1) establishes a new DCP registration for dispensing group
practices and dispensing assistants that dispense prescriptions directly
to patients, (2) authorizes pharmacists to refill prescriptions for certain
legend devices, (3) authorizes pharmacists to prescribe emergency or
hormonal contraception, (4) expands reasons for enforcement action
against a pharmacy to include delaying patients’ access to prescribed
drugs or other pharmacy services, and (5) makes minor changes to laws
related to compounding pharmaceuticals.
COMMITTEE ACTION
General Law Committee
Joint Favorable Substitute
Yea 16 Nay 7 (03/09/2023)