Connecticut General Statutes 21a-254 – Designation of restricted drugs or substances by regulations. Records required by chapter. Electronic prescription drug monitoring program. Information reporting of diabetes drugs and devices
(a) The Commissioner of Consumer Protection, after investigation and hearing, may by regulation designate certain substances as restricted drugs or substances by reason of their exceptional danger to health or exceptional potential for abuse so as to require written records of receipt, use and dispensation, and may, after investigation and hearing, remove the designation as restricted drugs or substances from any substance so previously designated.
Attorney's Note
Under the Connecticut General Statutes, punishments for crimes depend on the classification. In the case of this section:| Class | Prison | Fine |
|---|---|---|
| Class D felony | up to 5 years | up to $5,000 |
Terms Used In Connecticut General Statutes 21a-254
- Administer: means the direct application of a controlled substance, whether by injection, inhalation, ingestion or any other means, to the body of a patient or research subject by: (A) A practitioner, or, in his presence, by his authorized agent, or (B) the patient or research subject at the direction and in the presence of the practitioner, or (C) a nurse or intern under the direction and supervision of a practitioner. See Connecticut General Statutes 21a-240
- Agent: means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, dispenser or prescribing practitioner. See Connecticut General Statutes 21a-240
- another: may extend and be applied to communities, companies, corporations, public or private, limited liability companies, societies and associations. See Connecticut General Statutes 1-1
- Contract: A legal written agreement that becomes binding when signed.
- Controlled substance: means a drug, substance, or immediate precursor in schedules I to V, inclusive, of the Connecticut controlled substance scheduling regulations adopted pursuant to §. See Connecticut General Statutes 21a-240
- Dentist: means a person authorized by law to practice dentistry in this state. See Connecticut General Statutes 21a-240
- Dispenser: means a practitioner who dispenses. See Connecticut General Statutes 21a-240
- Drug: means (A) substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them. See Connecticut General Statutes 21a-240
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Manufacture: means the production, preparation, cultivation, growing, propagation, compounding, conversion or processing of a controlled substance, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of the substance or labeling or relabeling of its container, except that this term does not include the preparation or compounding of a controlled substance by an individual for his own use or the preparation, compounding, packaging or labeling of a controlled substance: (A) By a practitioner as an incident to his administering or dispensing of a controlled substance in the course of his professional practice, or (B) by a practitioner, or by his authorized agent under his supervision, for the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale. See Connecticut General Statutes 21a-240
- Nurse: means a person performing nursing as defined in §. See Connecticut General Statutes 21a-240
- Oversight: Committee review of the activities of a Federal agency or program.
- Person: includes any corporation, limited liability company, association or partnership, or one or more individuals, government or governmental subdivisions or agency, business trust, estate, trust, or any other legal entity. See Connecticut General Statutes 21a-240
- Pharmacist: means a person authorized by law to practice pharmacy pursuant to §. See Connecticut General Statutes 21a-240
- Pharmacy: means an establishment licensed pursuant to §. See Connecticut General Statutes 21a-240
- Physician: means a person authorized by law to practice medicine in this state pursuant to §. See Connecticut General Statutes 21a-240
- Practitioner: means : (A) A physician, dentist, veterinarian, podiatrist, scientific investigator or other person licensed, registered or otherwise permitted to distribute, dispense, conduct research with respect to or to administer a controlled substance in the course of professional practice or research in this state. See Connecticut General Statutes 21a-240
- Prescribe: means order or designate a remedy or any preparation containing controlled substances. See Connecticut General Statutes 21a-240
- Prescription: means a written, oral or electronic order for any controlled substance or preparation from a licensed practitioner to a pharmacist for a patient. See Connecticut General Statutes 21a-240
- Production: includes the manufacture, planting, cultivation, growing or harvesting of a controlled substance. See Connecticut General Statutes 21a-240
- Reasonable times: means the time or times any office, care-giving institution, pharmacy, clinic, wholesaler, manufacturer, laboratory, warehouse, establishment, store or place of business, vehicle or other place is open for the normal affairs or business or the practice activities usually conducted by the registrant. See Connecticut General Statutes 21a-240
- Registrant: means any person licensed by this state and assigned a current federal Bureau of Narcotics and Dangerous Drug Registry Number as provided under the federal Controlled Substances Act. See Connecticut General Statutes 21a-240
- State: when applied to a part of the United States, includes any state, district, commonwealth, territory or insular possession thereof, and any area subject to the legal authority of the United States of America. See Connecticut General Statutes 21a-240
- Unit dose drug distribution system: means a drug distribution system used in a hospital or chronic and convalescent nursing home in which drugs are supplied in individually labeled unit of use packages, each patient's supply of drugs is exchanged between the hospital pharmacy and the drug administration area or, in the case of a chronic and convalescent nursing home between a pharmacy and the drug administration area, at least once each twenty-four hours and each patient's medication supply for this period is stored within a patient-specific container, all of which is conducted under the direction of a pharmacist licensed in Connecticut and, in the case of a hospital, directly involved in the provision and supervision of pharmaceutical services at such hospital at least thirty-five hours each week. See Connecticut General Statutes 21a-240
- Veterinarian: means a person authorized by law to practice veterinary medicine in this state. See Connecticut General Statutes 21a-240
(b) Each physician, dentist, veterinarian or other person who is authorized to administer or professionally use schedule I substances shall keep a record of such schedule I substances received by him and a record of all such schedule I substances administered, dispensed or professionally used by him. The record of schedule I substances received shall in each case show the date of receipt, the name and address of the person from whom received and the kind and quantity of schedule I substances received. The record of all schedule I substances administered, dispensed or otherwise disposed of shall show the date of administering or dispensing, the name and address of the person to whom, or for whose use, or the owner and species of animal for which, the substances were administered or dispensed and the kind and quantity of substances.
(c) Practitioners obtaining and dispensing controlled substances shall keep a record of all such controlled substances, received and dispensed by them in accordance with the provisions of subsections (f) and (h) of this section.
(d) Manufacturers and wholesalers shall keep records of all controlled substances, compounded, mixed, cultivated or grown, or by any other process produced or prepared, and of all controlled substances received and disposed of by them in accordance with the provisions of subsections (f) and (h) of this section.
(e) Pharmacies, hospitals, chronic and convalescent nursing homes, rest homes with nursing supervision, clinics, infirmaries, freestanding ambulatory surgical centers and laboratories shall keep records of all controlled substances, received and disposed of by them in accordance with the provisions of subsections (f) and (h) of this section, except that hospitals and chronic and convalescent nursing homes using a unit dose drug distribution system may instead keep such records in accordance with the provisions of subsections (g) and (h) of this section, and except that hospitals and freestanding ambulatory surgical centers shall not be required to maintain separate disposition records for schedule V controlled substances or records of administering of individual doses for ultra-short-acting depressants, including but not limited to, Methohexital, Thiamylal and Thiopental.
(f) The form of record to be kept under subsection (c), (d) or (e) of this section shall in each case show the date of receipt, the name and address of the person from whom received, and the kind and quantity of controlled substances received, or, when applicable, the kind and quantity of controlled substances produced or removed from process of manufacture and the date of such production or removal from process of manufacture; and the record shall in each case show the proportion of controlled substances. The record of all controlled substances sold, administered, dispensed or otherwise disposed of shall show the date of selling, administering or dispensing, the name of the person to whom or for whose use, or the owner and species of animal for which, the substances were sold, administered or dispensed, the address of such person or owner in the instance of records of other than hospitals, chronic and convalescent nursing homes, rest homes with nursing supervision and infirmaries, and the kind and quantity of substances. In addition, hospital and infirmary records shall show the time of administering or dispensing, the prescribing physician and the nurse administering or dispensing the substance. Each such record of controlled substances shall be separately maintained apart from other drug records and kept for a period of three years from the date of the transaction recorded.
(g) Hospitals using a unit dose drug distribution system shall maintain a record noting all dispositions of controlled substances from any area of the hospital to other hospital locations. Such record shall include, but need not be limited to, the name, form, strength and quantity of the drug dispensed, the date dispensed and the location within the hospital to which the drug was dispensed. Such dispensing record shall be separately maintained, apart from other drug or business records, for a period of three years. Such hospital shall, in addition, maintain for each patient a record which includes, but need not be limited to, the full name of the patient and a complete description of each dose of medication administered, including the name, form, strength and quantity of the drug administered, the date and time administered and identification of the nurse or practitioner administering each drug dose. Entries for controlled substances shall be specially marked in a manner which allows for ready identification. Such records shall be filed in chronological order and kept for a period of three years.
(h) A complete and accurate record of all stocks of controlled substances on hand shall, on and after July 1, 1981, be prepared annually within four days of the first day of May of the calendar year, except that a registrant may change this date provided the general physical inventory date of such registrant is not more than six months from the annual inventory date, and kept on file for three years; and shall be made available to the commissioner or his authorized agents. All records required by this chapter shall be kept on the premises of the registrant and maintained current and separate from other business records in such form as to be readily available for inspection by the authorized agent at reasonable times. The use of a foreign language, codes or symbols to designate controlled substances or persons in the keeping of any required record is not deemed to be a compliance with this chapter.
(i) Whenever any record is removed by a person authorized to enforce the provisions of this chapter or the provisions of the state food, drug and cosmetic laws for the purpose of investigation or as evidence, such person shall tender a receipt in lieu thereof and the receipt shall be kept for a period of three years.
(j) (1) The commissioner shall, within available appropriations, establish an electronic prescription drug monitoring program to collect, by electronic means, prescription information for schedules II, III, IV and V controlled substances that are dispensed by pharmacies, nonresident pharmacies, as defined in § 20-627, outpatient pharmacies in hospitals or institutions or by any other dispenser, including, but not limited to, the federal Substance Abuse and Mental Health Services Administration certified substance use disorder clinics licensed under § 19a-495 in accordance with 42 CFR 2. The program shall be designed to provide information regarding the prescription of controlled substances in order to prevent the improper or illegal use of the controlled substances and shall not infringe on the legitimate prescribing of a controlled substance by a prescribing practitioner acting in good faith and in the course of professional practice.
(2) The commissioner may identify other products or substances to be included in the electronic prescription drug monitoring program established pursuant to subdivision (1) of this subsection.
(3) Prior to July 1, 2016, each pharmacy, nonresident pharmacy, as defined in § 20-627, outpatient pharmacy in a hospital or institution and dispenser shall report to the commissioner, at least weekly, by electronic means or, if a pharmacy or outpatient pharmacy does not maintain records electronically, in a format approved by the commissioner, the following information for all controlled substance prescriptions dispensed by such pharmacy or outpatient pharmacy: (A) Dispenser identification number; (B) the date the prescription for the controlled substance was filled; (C) the prescription number; (D) whether the prescription for the controlled substance is new or a refill; (E) the national drug code number for the drug dispensed; (F) the amount of the controlled substance dispensed and the number of days’ supply of the controlled substance; (G) a patient identification number; (H) the patient’s first name, last name and street address, including postal code; (I) the date of birth of the patient; (J) the date the prescription for the controlled substance was issued by the prescribing practitioner and the prescribing practitioner’s Drug Enforcement Agency’s identification number; and (K) the type of payment.
(4) (A) Except as provided in this subdivision, on and after July 1, 2016, each pharmacy, nonresident pharmacy, as defined in § 20-627, outpatient pharmacy in a hospital or institution, and dispenser shall report to the commissioner by electronic means, in a format approved by the commissioner, the following information for all controlled substance prescriptions dispensed by such pharmacy or outpatient pharmacy immediately upon, but in no event later than the next business day after, dispensing such prescriptions: (i) Dispenser identification number; (ii) the date the prescription for the controlled substance was filled; (iii) the prescription number; (iv) whether the prescription for the controlled substance is new or a refill; (v) the national drug code number for the drug dispensed; (vi) the amount of the controlled substance dispensed and the number of days’ supply of the controlled substance; (vii) a patient identification number; (viii) the patient’s first name, last name and street address, including postal code; (ix) the date of birth of the patient; (x) the date the prescription for the controlled substance was issued by the prescribing practitioner and the prescribing practitioner’s Drug Enforcement Agency’s identification number; and (xi) the type of payment.
(B) If the electronic prescription drug monitoring program is not operational, such pharmacy or dispenser shall report the information described in this subdivision not later than the next business day after regaining access to such program. For purposes of this subdivision, “business day” means any day during which the pharmacy is open to the public.
(C) Each veterinarian, licensed pursuant to chapter 384, who dispenses a controlled substance prescription shall report to the commissioner the information described in subparagraph (A) of this subdivision, at least weekly, by electronic means or, if the veterinarian does not maintain records electronically, in a format approved by the commissioner.
(5) The commissioner may contract with a vendor for purposes of electronically collecting such controlled substance prescription information. The commissioner and any such vendor shall maintain the information in accordance with the provisions of chapter 400j.
(6) The commissioner and any such vendor shall not disclose controlled substance prescription information reported pursuant to subdivisions (3) and (4) of this subsection, except as authorized pursuant to the provisions of sections 21a-240 to 21a-283, inclusive. Any person who knowingly violates any provision of this subdivision or subdivision (5) of this subsection shall be guilty of a class D felony.
(7) The commissioner shall provide, upon request, controlled substance prescription information obtained in accordance with subdivisions (3) and (4) of this subsection to the following: (A) The prescribing practitioner or such practitioner’s authorized agent, who is treating or has treated a specific patient, provided the information is obtained for purposes related to the treatment of the patient, including the monitoring of controlled substances obtained by the patient; (B) the prescribing practitioner with whom a patient has made contact for the purpose of seeking medical treatment or such practitioner’s authorized agent, provided the request is accompanied by a written consent, signed by the prospective patient, for the release of controlled substance prescription information; or (C) the pharmacist who is dispensing controlled substances for a patient, or such pharmacist’s authorized pharmacy technician, provided the information is obtained for purposes related to the scope of the pharmacist’s practice and management of the patient’s drug therapy, including the monitoring of controlled substances obtained by the patient. The prescribing practitioner, such practitioner’s authorized agent, the pharmacist or such pharmacist’s authorized pharmacy technician shall submit a written and signed request to the commissioner for controlled substance prescription information. Such prescribing practitioner, pharmacist or pharmacist’s authorized pharmacy technician shall not disclose any such request except as authorized pursuant to sections 20-570 to 20-630, inclusive, or sections 21a-240 to 21a-283, inclusive.
(8) No person or employer shall prohibit, discourage or impede a prescribing practitioner, pharmacist or pharmacist’s authorized pharmacy technician from requesting controlled substance prescription information pursuant to this subsection.
(9) Prior to prescribing greater than a seventy-two-hour supply of any controlled substance to any patient, the prescribing practitioner or such practitioner’s authorized agent shall review the patient’s records in the electronic prescription drug monitoring program established pursuant to this subsection. Whenever a prescribing practitioner prescribes a controlled substance, other than a schedule V nonnarcotic controlled substance, for the continuous or prolonged treatment of any patient, such prescriber, or such prescriber’s authorized agent, shall review, not less than once every ninety days, the patient’s records in such prescription drug monitoring program. Whenever a prescribing practitioner prescribes a schedule V nonnarcotic controlled substance, for the continuous or prolonged treatment of any patient, such prescribing practitioner, or such prescribing practitioner’s authorized agent, shall review, not less than annually, the patient’s records in such prescription drug monitoring program. If such electronic prescription drug monitoring program is not operational, such prescribing practitioner may prescribe greater than a seventy-two-hour supply of a controlled substance to a patient during the time of such program’s inoperability, provided such prescribing practitioner or such authorized agent reviews the records of such patient in such program not more than twenty-four hours after regaining access to such program.
(10) (A) A prescribing practitioner may designate an authorized agent to review the electronic prescription drug monitoring program 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 C.F.R. § 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 § 21a-322.
(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 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 § 21a-322. The commissioner may inspect hospital records to determine compliance with written protocols approved in accordance with this section.
(C) A pharmacist may designate a pharmacy technician to access the electronic prescription drug monitoring program and patient controlled substance prescription information on behalf of the pharmacist only for the purposes of facilitating the pharmacist’s review of such patient information. The pharmacist shall ensure that any such pharmacy technician’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 pharmacist and any authorized pharmacy technician shall be subject to the provisions of 45 C.F.R. § 164.308, as amended from time to time, concerning administrative safeguards for the protection of electronic protected health information. A pharmacist may be subject to disciplinary action for acts of the authorized pharmacy technician.
(D) Prior to designating a pharmacy technician to access the electronic prescription drug monitoring program and patient controlled substance prescription information on behalf of the pharmacist, the supervising pharmacist shall provide training for the authorized pharmacy technicians. Such training shall designate a pharmacist as the person responsible for ensuring that the authorized pharmacy technician’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. A pharmacist designated as the person responsible for overseeing the pharmacy technician’s access to such program may be subject to disciplinary action for acts of the authorized pharmacy technician. The commissioner may inspect records to document pharmacy technician training, that pharmacy technicians have access to the program and that patient controlled substance prescription information has been limited in accordance with the provisions of this section.
(11) The commissioner shall adopt regulations, in accordance with chapter 54, concerning the reporting, evaluation, management and storage of electronic controlled substance prescription information.
(12) The provisions of this section shall not apply to (A) samples of controlled substances dispensed by a physician to a patient, or (B) any controlled substances dispensed to hospital inpatients.
(13) The provisions of this section shall not apply to any institutional pharmacy or pharmacist’s drug room operated by a facility, licensed under § 19a-495 and regulations adopted pursuant to said § 19a-495, that dispenses or administers directly to a patient an opioid agonist for treatment of a substance use disorder, unless the patient has signed a consent to disclose the patient’s records to a prescription drug monitoring program that is compliant with 42 C.F.R. § part 2 Subpart B. Each signed consent form shall be made available for review by the commissioner upon request. If consent is withdrawn by the patient, the institutional pharmacy or pharmacist’s drug room operated by a facility shall immediately discontinue disclosing information about the specific patient who withdrew consent.
(14) The commissioner may provide controlled substance prescription information obtained in accordance with subdivisions (3) and (4) of this subsection to other state agencies, pursuant to an agreement between the commissioner and the head of such agency, provided the information is obtained for a study of disease prevention and control related to opioid abuse or the study of morbidity and mortality caused by overdoses of controlled substances. The provision of such information shall be in accordance with all applicable state and federal confidentiality requirements.
(15) Nothing in this section shall prohibit a prescribing practitioner or such prescribing practitioner’s authorized agent from disclosing controlled substance prescription information submitted pursuant to subdivisions (3) and (4) of this subsection to the Department of Social Services for the purposes of administering any of said department’s medical assistance programs.
(16) Each pharmacy, nonresident pharmacy, as defined in § 20-627, outpatient pharmacy in a hospital or institution, and dispenser shall report to the commissioner, at least daily, by electronic means or, if a pharmacy or outpatient pharmacy does not maintain records electronically, in a format approved by the commissioner information for all insulin drugs, glucagon drugs, diabetes devices and diabetic ketoacidosis devices prescribed and dispensed by such pharmacy or outpatient pharmacy, except such reporting requirement shall not apply to any veterinarian, licensed under chapter 384, who dispenses insulin drugs, glucagon drugs, diabetes devices and diabetic ketoacidosis devices for animal patients. Such pharmacy or outpatient pharmacy shall report such information to the commissioner in a manner that is consistent with the manner in which such pharmacy or outpatient pharmacy reports information for controlled substance prescriptions pursuant to subdivision (4) of this subsection. For the purposes of this subdivision, “insulin drug”, “glucagon drug”, “diabetes devices” and “diabetic ketoacidosis device” have the same meanings as provided in § 20-616.