SB 694 — AN ACT EXEMPTING VETERINARIANS FROM THE REQUIREMENT TO REPORT CERTAIN DISPENSED DIABETES DRUGS AND DEVICES TO THE PRESCRIPTION DRUG MONITORING PROGRAM.

Subsection (a) of section 21a-70 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2021):

(a)Asused inthissection:(1) "Drugs","devices"and"cosmetics" have the same meanings as defined in section 21a-92, "wholesaler" or "distributor" means a person, including, but not limited to, a medical device and oxygen provider, a third-party logistics provider, a virtual manufacturer or a virtual wholesale distributor, as such terms are defined in section 20-571, whether within or without the boundaries of the state of Connecticut, who supplies drugs, devices or cosmetics prepared, produced or packaged by manufacturers, to other wholesalers, manufacturers, distributors, hospitals, prescribing practitioners, as defined in subdivision (24) of section 20-571, pharmacies, federal, state or municipal agencies, clinics or any other person as permitted under subsection (h) of this section, except that:

(A) A retail pharmacy or a pharmacy within a licensed hospital that supplies to another such pharmacy a quantity of a noncontrolled drug or a schedule II, III, IV or V controlled substance normally stocked by such pharmacies to provide for the immediate needs of a patient pursuant to a prescription or medication order of an authorized practitioner, (B) a pharmacy within a licensed hospital that supplies drugs to another hospital or an authorized practitioner for research purposes, (C) a retail pharmacy that supplies a limited quantity of a noncontrolled drug or of a schedule II, III, IV or V controlled substance for emergency stock to a practitioner who is a medical director of a chronic and convalescent nursing home, of a rest home with nursing sSB694 / File No.

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108 supervision, of a hospice inpatient facility licensed pursuant to section 19a-491 or of a state correctional institution, and (D) a pharmacy within a licensed hospital that contains another hospital wholly within its physical structure that supplies to such contained hospital a quantity of a noncontrolled drug or a schedule II, III, IV, or V controlled substance normally stocked by such hospitals to provide for the needs of a patient, pursuant to a prescription or medication order of an authorized practitioner, receiving inpatient care on a unit that is operated by the contained hospital, or receiving outpatient care in a setting operated by the contained hospital and such drug or substance is administered on- site by the contained hospital, shall not be deemed a wholesaler under this section;

(2) "manufacturer" means (A) a person, whether within or without the boundaries of the state of Connecticut, who produces, prepares, cultivates, grows, propagates, compounds, converts or processes, directly or indirectly, by extraction from substances of natural origin or by means of chemical synthesis or by a combination of extraction and chemical synthesis, or who packages, repackages, labels or relabels a container under such manufacturer's own or any other trademark or label any drug, device or cosmetic for the purpose of selling such items, or (B) a sterile compounding pharmacy, as defined in section 20-633b, as amended by this act, that dispenses sterile pharmaceuticals without a prescription or a patient-specific medical order;

(3) "drug", "device" and "cosmetic" have the same meanings as provided in section 21a-92;

and (4) "commissioner" means the Commissioner of Consumer Protection or his or her designee.

This act shall take effect as follows and shall amend the following sections:

Section 1 October 1, 2021 21a-319 Sec.

2 from passage New section Sec.

3 from passage 20-633b(f) Sec.

4 from passage 20-614(d) Sec.

5 July 1, 2021 21a-70(a) Statement of Legislative Commissioners:

Section 2(b) was reorganized for clarity.

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108 GL Joint Favorable Subst.

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108 The following Fiscal Impact Statement and Bill Analysis are prepared for the benefit of the members of the General Assembly, solely for purposes of information, summarization and explanation and do not represent the intent of the General Assembly or either chamber thereof for any purpose.

In general, fiscal impacts are based upon a variety of informational sources, including the analyst’s professional knowledge.

Whenever applicable, agency data is consulted as part of the analysis, however final products do not necessarily reflect an assessment from any specific department.

OFA Fiscal Note State Impact:

None Municipal Impact:

None Explanation The bill makes various changes to pharmacies and drug control statutes resulting in no fiscal impact to the state.

The Out Years State Impact:

None Municipal Impact:

None sSB694 / File No.

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108 OLR Bill Analysis sSB 694 AN ACT CONCERNING REVISIONS TO PHARMACY AND DRUG CONTROL STATUTES.

SUMMARY This bill makes various unrelated changes to the laws concerning pharmacies and drugs, including:

1.

allowing the Department of Consumer Protection (DCP) to immediately inactivate a practitioner’s controlled substance registration if his or her license, registration, or approval of a license to practice is inactive for more than 90 days (§ 1);

2.

allowing pharmacists to prescribe an epinephrine auto injector (e.g., EpiPen) to someone who previously had a prescription for one, under certain circumstances (§ 2);

3.

increasing from 10 to 45 days, the advance notice a compounding facility must give DCP when it plans to remodel or repair its sterile compounding facilities, and requiring emergency repairs to be reported within 24 hours (§ 3);

and 4.

expanding therequirement that pharmacists offer to consult with patients when dispensing medications to include controlled substances, in addition to other drug types, and applying the requirement to all pharmacies (§ 4).

The bill also exempts from registering with DCP as a “drug wholesaler” (1) retail pharmacies that provide a limited quantity of drugs for emergency stock to a hospice inpatient facility’s medical director and (2) pharmacies within a hospital that contains another hospital wholly within its physical structure, if providing prescribed medications to be administered onsite to the contained hospital’s sSB694 / File No.

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108 outpatients (§ 5).

Existing law provides similar exemptions for pharmacies (1) that provide emergency stock to nursing homes or (2) within a hospital that contains another hospital, when the drug will be used in the contained hospital’s inpatient unit.

Lastly, the bill makes minor and technical changes.

EFFECTIVE DATE:

Upon passage, except the controlled substance registration provision is effective October 1, 2021 (§ 1) and the drug wholesaler definition provision is effective July 1, 2021 (§ 5).

§ 1 — CONTROLLED SUBSTANCE REGISTRATIONS The bill allows DCP to immediately inactivate a practitioner’s controlled substance registration if his or her license to practice, or related registration or approval, is inactive for more than 90 days.

Current law requires DCP to notify the practitioner and hold an administrative hearing prior to taking such action.

The bill specifies that an inactivation is not a disciplinary action and that the controlled substance registration must be reinstated without charge if the practitioner restores his or her license, registration, or approval to practice with the Department of Public Health or the associatedboardorcommissionbeforetheregistrationwassettoexpire.

By law, a practitioner who prescribes, distributes, administers, or dispenses a controlled substance must obtain a registration from DCP.

Practitioners eligible for the registration include physicians, dentists, veterinarians, advanced practice registered nurses, and scientific investigators, among others.

§ 2 — EPINEPHRINE AUTO INJECTOR PRESCRIPTIONS The bill permits a pharmacist, in his or her professional discretion, to issue a prescription for up to two epinephrine auto injectors if the pharmacist:

1.

confirms another pharmacy has dispensed the medication to the patient under a prescription within the past two years;

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108 2.

identifies the patient's primary care provider, based on information the patient provides when requesting the prescription;

3.

informs the patient's primary care provider within seventy-two hours after issuing the prescription (by phone, fax, or electronic transmission);

and 4.

does not prescribe refills or fill the prescription more than once per year.

The bill defines "epinephrine auto injector" as 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.

The bill specifies that it does not prevent a pharmacist from verifying a previous prescription at any other U.S.

pharmacy, including pharmacies in any area under U.S.

jurisdiction (e.g., a territory).

§ 3 — STERILE COMPOUNDING FACILITY CHANGES The bill increases, from 10 to 45 days, the advance notice a compounding facility must give DCP before it begins to remodel, relocate, upgrade, or repair sterile compounding areas or adjacent spaces, including:

1.

remodeling an area used for compounding sterile pharmaceuticals or an adjacent space;

2.

relocating the sterile compounding area;

or 3.

in a sterile compounding area, upgrading or conducting a nonemergencyrepairtotheheating,ventilation,airconditioning, or primary or secondary engineering controls.

The bill also requires emergency repairs made in these pharmacies to be reported within 24 hours after they started, instead of as soon as possible as under current law.

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108 Additionally, the bill makes related minor changes, including requiring notice when secondary engineering controls are upgraded or repaired.

§ 4 — PHARMACIST CONSULTATIONS The bill requires pharmacists or pharmacy employees, before or while dispensing a controlled substance, to offer for the pharmacist to counsel a patient on the drug and its use.

Current law already requires pharmacists and employees to do this for other dispensed drug types.

As under current law, the requirement does not apply if the (1) person picking up the prescription is not the patient or (2) pharmacist determines it is appropriate to make the offer in writing.

A written offer must give the patient the option to communicate in person at the pharmacy or by telephone.

The bill specifies that the consultation requirement applies to all pharmacies instead of only (1) hospital pharmacies, when dispensing a drug for outpatient use or use by an employee or the employee’s spouse or children, and (2) state-licensed pharmacies.

As under current law, pharmacists are not required to provide counseling if a patient refuses it.

COMMITTEE ACTION General Law Committee Joint Favorable Substitute Yea 19 Nay 0 (03/09/2021) sSB694 / File No.

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