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OLR Bill Analysis
sSB 1102
AN ACT CONCERNING PHARMACIES AND PHARMACISTS.
SUMMARY
This bill makes changes in the laws concerning 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;
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; and
8. requires DCP to adopt regulations on prescription pickup lockers
at pharmacies, but allows for their use before the regulations are
adopted under specified circumstances. 2023SB-01102-R000221-BA.DOCX
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The bill also makes minor, technical, and conforming changes.
EFFECTIVE DATE: July 1, 2023
§§ 1 & 6-16 — HEALTH CARE INSTITUTIONAL PHARMACIES’
STERILE COMPOUNDING
The bill establishes a process to allow institutional pharmacies
located in licensed healthcare 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
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 2023SB-01102-R000221-BA.DOCX
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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 — EXPANDING PHARMACISTS’ SCOPE OF PRACTICE
The bill expands pharmacists’ scope of practice by authorizing them
to (1) administer additional vaccinations 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).
Vaccinations
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. 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. (Additionally, under
temporary federal rules (see BACKGROUND) , pharmacists can
currently administer various vaccines to children ages 3 and older.)
The bill permanently expands the types of vaccines pharmacists can
administer to people ages 12 or older. Under the bill, they 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: 2023SB-01102-R000221-BA.DOCX
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1. on the adult immunization schedule and authorized by the FDA,
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. For current law’s limits on influenza vaccines for
minors, the bill correspondingly (1) eliminates the requirement that an
influenza vaccine only be administered if ordered by a health care
provider and (2) aligns the parameters on consent with those described
above for other vaccines 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
pharmacists to administer.
Administering 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 2023SB-01102-R000221-BA.DOCX
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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
Under temporary federal rules, pharmacists can currently order and
administer COVID-related tests. The bill permanently allows
pharmacists to order and administer COVID-19, HIV, and influenza
related tests if they are employed by a:
1. hospital or
2. pharmacy that has given the Department of Public Health (DPH)
a complete clinical laboratory improvement amendment
application for certification for a COVID-19, HIV, or influenza
related test.
They may do so for any patient ages18 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.
When pharmacists order and administer a test, they must give the
patient the test results in writing and maintain a record of them for at
least three years.
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-exposure or post-exposure HIV-related prophylaxis. The
pharmacist may do so only if the (1) patient meets the criteria on the
package insert and (2) prophylaxis is prescribed and dispensed in
conformity with the state’s pharmacy laws.
Sharing Test Results and HIV Prophylaxis Information With DCP
Upon the DCP commissioner or his or her designee’s request, a
pharmacist must share the results of a COVID-19, HIV, or influenza
related test with DCP. Similarly, if a pharmacist prescribes HIV-related 2023SB-01102-R000221-BA.DOCX
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prophylaxis, DCP may request a copy of the test results, prescription
records, and any other documents the commissioner requires by
regulations. (Presumably, the regulations DCP must adopt, as described
below, will address applicable privacy laws.)
Regulations Related to Testing and HIV Prophylaxis Prescribing
The bill requires the DCP commissioner, in consultation with the
DPH commissioner and Commission of Pharmacy, to adopt regulations
to implement the bill’s testing and prescribing authorizations. The
regulations must (1) identify qualifying training programs accredited by
the CDC, the Accreditation Council for Pharmacy Education, or another
appropriate national accrediting body and (2) 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 offers (1) temporary clinics, vaccination
events, or opioid antagonist training and prescribing events or (2)
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 it finds
necessary, 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-R000221-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 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 FDA 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, (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 update it. The plan must
also be given to and reviewed with all pharmacy personnel annually.
The plan must include the name of: 2023SB-01102-R000221-BA.DOCX
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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
medications from a nearby pharmacy; 2023SB-01102-R000221-BA.DOCX
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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 That Are 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
original prescription was first dispensed, (d) number of refills 2023SB-01102-R000221-BA.DOCX
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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. are able to 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.
BACKGROUND
Federal PREP Act and Pharmacists’ Administration of Vaccines
The federal Public Readiness and Emergency Preparedness Act 2023SB-01102-R000221-BA.DOCX
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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 a
declaration authorizing state-licensed pharmacists, under certain
criteria, to (1) order and administer vaccinations to minors ages 3 and
older and (2) order and administer COVID-19 tests.
Related Bill
sHB 6788, 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)