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OLR Bill Analysis
sSB 1355
AN ACT CONCERNING PRESCRIPTION DRUGS, DEVICES AND
NONLEGEND DRUGS.
SUMMARY
This bill makes a number of unrelated changes. Among other things,
it:
1. requires the Department of Consumer Protection (DCP), in
consultation with the Commission of Pharmacy, to adopt certain
regulations (a) regarding nonsterile compounding pharmacies,
including to ensure access to certain products that contain
levonorgestrel, mifepristone, misoprostol, or similar ingredients,
and (b) to import levonorgestrel, mifepristone, misoprostol, and
similar drugs and components to offer ready access to drug
products that include them (§ 1);
2. eliminates a requirement that DCP prominently post lists of
pharmaceutical representatives employed by registered
pharmaceutical manufacturers on its website (but keeps the
requirement that these manufacturers annually give these lists to
DCP and update them within two weeks of any changes) (§ 2);
3. allows a licensed veterinarian to authorize another person to
dispense a prescription veterinary drug under certain
circumstances (§ 3);
4. authorizes DCP or the Commission of Pharmacy, depending on
the credential, to take various actions when a credential holder
takes certain actions involving a drug that the holder knows will
be used by someone to execute a death sentence (§§ 4-12); and
5. (a) excludes, from the requirement to get a DCP permit to sell
nonlegend drugs in a vending machine, distributing free 2025SB-01355-R000608-BA.DOCX
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nonlegend naloxone through a legally compliant secure box; (b)
makes various other changes regarding these permits; and (c)
changes the requirements for secure boxes (§§ 13-15).
EFFECTIVE DATE: Upon passage, except the provisions related to
drugs used to execute a death sentence are effective October 1, 2025.
§ 1 — NONSTERILE COMPOUNDING PHARMACY REGULATIONS
The bill requires the DCP commissioner, in consultation with the
Commission of Pharmacy, to adopt certain regulations on nonsterile
compounding pharmacies, which are licensed pharmacies that dispense
nonsterile compounded pharmaceutical products. These are drug
products made by compounding at least one active or nonactive
ingredient.
The bill requires the regulations to ensure that these pharmacies can
engage in nonsterile compounding:
1. under state laws and regulations and the provisions of the United
States Pharmacopeia standards on nonsterile preparations and
2. to maintain patients’ ready access to nonsterile compounded
pharmaceutical products that contain levonorgestrel,
mifepristone, misoprostol, or a similar ingredient as an active
ingredient.
The regulation must also provide for DCP (or public-private
partnerships it is involved with) to import (a) levonorgestrel,
mifepristone, and misoprostol as drug products and components and
(b) similar drugs and components, in order to offer ready access to drug
products with these, or similar, active ingredients.
The bill allows DCP to issue policies and procedures to implement
these provisions before adopting the regulations. DCP must post the
policies and procedures on its website and submit them for posting on
the eRegulations System at least 15 days before they take effect. The
policies and procedures expire when the regulations are adopted or 48
months after the bill takes effect if a regulation has not been submitted 2025SB-01355-R000608-BA.DOCX
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to the Regulation Review Committee for consideration, whichever
occurs first.
Levonorgestrel is an emergency contraceptive used to prevent
pregnancy. Mifepristone and misoprostol are used together to end a
pregnancy through 10 weeks gestation.
§ 3 — VETERINARIANS
The bill allows a licensed veterinarian to authorize another person to
dispense a prescription veterinary drug if done:
1. under a veterinarian’s lawful written or oral order in the course
of the veterinarian’s professional practice and following federal
and state laws and regulations on dispensing prescription
veterinary drugs;
2. for an animal the veterinarian, or another veterinarian at the
same practice who has access to the animal’s medical records, has
a veterinarian-client-patient relationship; and
3. under the direct supervision of one of the veterinarians described
above.
The veterinarian who authorizes another person to dispense the drug
must ensure that all requirements for dispensing the drug are followed.
The bill allows the Department of Public Health commissioner, in
consultation with DCP and the Connecticut Board of Veterinary
Medicine, to adopt regulations to implement these provisions.
§§ 4-12 — DRUGS USED TO EXECUTE DEA TH SENTENCES
Generally, the bill prohibits manufacturing, selling, or dispensing a
drug while knowing that the person receiving it intends to use it to
execute a death sentence. And the bill authorizes DCP or the
Commission of Pharmacy (depending on the credential) to take various
actions, based on a credential holder taking certain actions, under these
circumstances.
Drug Manufacturers and Wholesalers (§§ 4-6) 2025SB-01355-R000608-BA.DOCX
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By law, drug manufacturers and wholesalers must register with DCP.
Currently, a prison with a pharmacy that provides an emergency stock
of certain drugs for its medical director is not a wholesaler and is not
required to register. The bill provides that a prison with such a
pharmacy is considered a wholesaler and required to register when it
has actual knowledge that a noncontrolled drug or controlled substance
will be used to execute a death sentence. (The bill does not specify how
to attribute this knowledge to the institution.)
By law, the DCP commissioner can deny a registration certificate if
issuing one would be inconsistent with the public interest. The law sets
out a number of factors the commissioner must consider in making this
determination, including certain convictions or regulatory actions, the
applicant’s past experience and regulatory compliance, and provision of
adequate controls and security. The bill also requires the commissioner
to consider if the applicant manufactured, sold, or dispensed a drug or
device actually knowing that the person purchasing or receiving it
directly from the applicant intended to use it to execute a death
sentence.
The law specifies a number of reasons that are sufficient for the
commissioner to suspend, revoke, or refuse to renew a registration,
reprimand a registrant, or place a registrant on probation, such as
criminal convictions related to drugs, providing false information, not
providing adequate controls, or violating state or federal law related to
drugs. The bill adds to this list manufacturing, selling, or dispensing a
drug or device when actually knowing that the person purchasing or
receiving it directly from the registrant intends to use it to execute a
death sentence.
The bill requires an applicant or registrant seeking renewal to attest
to the commissioner in a signed written statement that the applicant or
registrant will not manufacture, sell, or dispense a drug or device when
actually knowing that the person purchasing or receiving it directly
from the applicant or registrant intends to use it to execute a death
sentence. The DCP commissioner sets the form and manner of this
statement. 2025SB-01355-R000608-BA.DOCX
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The law requires a manufacturer or wholesaler to obtain a DCP
license to sell and dispense controlled substances. The bill prohibits a
licensed manufacturer or wholesaler from selling or dispensing a
controlled drug directly to another person while actually knowing that
the person intends to use it to execute a death sentence.
Certain Individuals (§ 6)
Current law allows the person in charge of a hospital, college,
scientific institution, or laboratory, an employee of this or another state
or their political subdivisions, or a proper officer of a ship or aircraft
who obtains a controlled substance to administer it within the scope of
his or her employment or duty and only for scientific or medicinal
purposes or research or analysis. The bill prohibits these individuals
from obtaining, dispensing, or using a controlled drug to execute a
death sentence.
Pharmacists (§§ 7 & 8)
By law, the Commission of Pharmacy can refuse to issue a temporary
permit to practice pharmacy; refuse to issue or renew a license to
practice pharmacy or operate a pharmacy or registration of a pharmacy
intern or technician; revoke, suspend, or place conditions on any of
these credentials; reprimand or place on probation a credential holder;
or assess a civil penalty of up to $1,000 per violation for numerous
grounds. The bill adds to the permissible grounds for these actions that
while holding the credential, the person dispensed or distributed a drug
or device directly to someone while actually knowing that the person
intended to use it to execute a death sentence.
The bill also prohibits the commission from renewing a pharmacist
license if within the calendar year before the application the person
dispensed or distributed a drug or device directly to someone while
actually knowing that the person intended to use it to execute a death
sentence.
Prescriptions (§§ 9 & 10)
The bill prohibits a prescribing practitioner (a person licensed by any
state or U.S. jurisdiction who is authorized to issue a prescription within 2025SB-01355-R000608-BA.DOCX
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the scope of the person’s practice) from dispensing or transferring a
drug or device directly to someone while actually knowing that the
person intends to use it to execute a death sentence.
The bill makes any request for a controlled substance to execute a
death sentence an invalid prescription and considers it outside the
context of a valid practitioner-patient relationship.
Nonresident Pharmacy Registration Certificate (§ 11)
Current law allows the Commission of Pharmacy to deny, revoke, or
suspend a registration certificate of a nonresident pharmacy for failing
to comply with state or federal laws or regulations, delivering a legend
drug or device that is adulterated or misbranded, or disciplinary actions
taken against the pharmacy by any state or federal agency. The bill adds
as an additional ground for these actions by the commission that the
pharmacy delivered a legend drug or device directly to someone while
actually knowing that the person intends to use it to execute a death
sentence.
Sterile Compounding Pharmacies (§ 12)
The bill prohibits a sterile compounding pharmacy from providing,
selling, or transferring a sterile pharmaceutical directly to someone
while actually knowing that the person intends to use it to execute a
death sentence.
§§ 13-15 — VENDING MACHINES AND SECURE LOCKBOXES
Vending Machine Permits to Sell Nonlegend Drugs
Current law requires a business that owns and operates a vending
machine to obtain a permit from DCP or the Commission of Pharmacy
in order to sell nonlegend drugs. The bill only allows DCP to issue these
permits and allows the DCP commissioner to set the form and manner
of an application.
The bill excludes from the permit requirement someone who only
distributes nonlegend naloxone to the public through a secure, legally
compliant lockbox (see below) for free. 2025SB-01355-R000608-BA.DOCX
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The bill waives the $140 application fee and $100 renewal fee for a
permit to sell nonlegend drugs for an applicant who attests on the
application that the permit will be used only to distribute nonlegend
drugs for free.
The bill specifies that the late fee on renewal of a permit is 10% of the
renewal fee, but must be between $10 and $100.
Currently, a permit holder must notify the commission of a change in
ownership, name, or location within five days after the change. The bill
instead requires a permit holder to electronically submit the change to
DCP in a form and manner set by the DCP commissioner, and requires
notice of a change of permanent physical location rather than change of
location of permit premises.
The bill eliminates a provision making these permits nontransferable.
Secure Boxes
The bill changes certain requirements for secure lockboxes. As under
current law, the box must be securely affixed in a public location and be
accessible by people for public use. The bill deletes requirements that it
be (1) temperature controlled or in a temperature-controlled
environment; (2) tamper resistant; and (3) equipped with an alarm that
transmits a signal and alerts first responders when accessed by
someone. The bill adds that the box must display any sign DCP deems
necessary or appropriate for the purposes of the relevant statute (DCP
must post an image of the required sign on its website).
By law, a prescribing practitioner or pharmacist certified to prescribe
an opioid antagonist can enter an agreement with a community health
organization, emergency medical service provider, government or law
enforcement agency, or board of education to install a secure box
containing an opioid antagonist (such as naloxone). The agreement
must address certain topics, such as environmental contro ls,
replenishing contents, monitoring expiration dates, and signage about
location and usage directions.
COMMITTEE ACTION 2025SB-01355-R000608-BA.DOCX
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General Law Committee
Joint Favorable Substitute
Yea 14 Nay 8 (03/24/2025)