SubTitle21a-254-1_21a-254-7. Record Keeping for Controlled Drugs, Title21a Consumer Protection, Regulations of Connecticut State Agencies

Regulations of Connecticut State Agencies (Last Updated: June 14,2023)

SubTitle21a-254-1_21a-254-7. Record Keeping for Controlled Drugs

Sec. 21a-254-1. Records

Latest version.

(a) In general, special and long-term hospitals there shall be a separate proof of use sheet as required in subsection (e) of section 21a-254 of the general statutes for controlled drugs which are not dispensed or administered directly to patients from the hospital's pharmacy but are administered or dispensed from each floor stock. Such proof of use record shall show the date of administering or dispensing, the name of the person to whom or for whose use the drug is administered or dispensed, the kind and quantity of drug, the time of administering or dispensing, the prescribing physician and the nurse administering or dispensing the drug.

(b) In general, special and long-term hospitals where controlled drugs are dispensed or administered directly to patients from the hospital's pharmacy in quantities not exceeding four days' supply, the hospital may use a duplicate copy of the patient's medication record to record the drug administration or dispensing in lieu of a separate proof of use record as required by said subsection (e) of section 21a-254. Such records and any unused drugs or portions thereof shall be promptly returned to the hospital pharmacy when no longer required by the patient.

(Effective July 27, 1984)

Sec. 21a-254-2. Definitions

Latest version.

As used in sections 21a-254-2 to 21a-254-7, inclusive, of the Regulations of Connecticut State Agencies:

(1) "Controlled substance" means "controlled substance" as defined in section 21a-240 of the Connecticut General Statutes;

(2) "Department" means the Department of Consumer Protection;

(3) "Pharmacy" means "pharmacy" as defined in section 20-571 of the Connecticut General Statutes, or a pharmacy located in a hospital, long term care facility or correctional facility; and

(4) "Practitioner" means "Prescribing practitioner" as defined in section 20-571 of the Connecticut General Statutes.

(Adopted effective August 1, 2007)

Sec. 21a-254-3. General requirements

Latest version.

A pharmacy that dispenses schedule II, III, IV, and V controlled substances shall transmit the prescription information for these controlled substances to the department. A hospital pharmacy, long term care facility pharmacy or correctional facility pharmacy shall transmit controlled prescription information for outpatients only.

(Adopted effective August 1, 2007)

Sec. 21a-254-4. Reporting

Latest version.

(a) A pharmacy that maintains prescription information electronically, and that dispenses a schedule II, III, IV, or V controlled substance to a person who is not an inpatient of a hospital, correctional institution or nursing facility, shall transmit electronically to the Drug Control Division of the department the information set forth in the most recent edition of the Electronic Reporting Standard for Prescription Monitoring Programs established by the American Society for Automation in Pharmacy. A pharmacy shall transmit to the department the fields listed in said reporting standard, including, but not limited to, the following:

(1) Drug Enforcement Administration Pharmacy number;

(2) Birth date;

(3) Sex code;

(4) Date prescription filled;

(5) Prescription number;

(6) New-refill code;

(7) Quantity;

(8) Days supply;

(9) National Drug Code number;

(10) Drug Enforcement Administration Prescriber identification number;

(11) Date prescription written;

(12) Number of refills authorized;

(13) Prescription origin code;

(14) Patient last name;

(15) Patient first name;

(16) Patient street address;

(17) State;

(18) Payment code for either cash or third-party provider; and

(19) Drug name.

(b) A copy of the Electronic Reporting Standard for Prescription Monitoring Programs may be obtained from the American Society for Automation in Pharmacy, 492 Norristown Road, Suite 160, Blue Bell, Pennsylvania 19422. Telephone: (610) 825-7783. Website: www.asapnet.org.

(c) A pharmacy that maintains prescription information electronically shall transmit the required information by means of one of the following methods:

(1) Electronic data transmission through a computer modem that can transmit information at a rate of 2400 baud or more;

(2) Computer disc; or

(3) Magnetic tape of the kind that is used to transmit information between computerized systems.

(d) A pharmacy that does not maintain prescription information electronically, and that dispenses a schedule II, III, IV, or V controlled substance to a person who is not an inpatient of a hospital, correctional institution or nursing facility, shall transmit to the Drug Control Division of the department the information set forth in subsection (a) of this section on a paper form provided by the department.

(e)

(1) A pharmacy shall transmit to the department the information required pursuant to this section not later than:

(A) The 20^th day of the month for all prescriptions dispensed on and between the 1^st and the 15^th days of the month; and

(B) The 5^th day of the following month for all prescriptions dispensed on and between the 16^th day and the last day of the month.

(2) If the reporting date falls on weekend or a holiday, a pharmacy shall transmit the required information by the next state of Connecticut workday.

(f) A pharmacy shall transmit the information required pursuant to this section in such a manner as to insure the confidentiality of the information in compliance with all federal and state statutes and regulations, including the federal Health Insurance Portability and Accountability Act of 1996.

(Adopted effective August 1, 2007)

Sec. 21a-254-5. Evaluation

Latest version.

Agents of the Drug Control Division of the department, and any department employee authorized to work with the Drug Control Division, shall evaluate the controlled substance prescription information received from pharmacies. The department shall evaluate the prescription information for the purposes of preventing controlled substance diversion, public health initiatives, and statistical reporting.

(Adopted effective August 1, 2007)

Sec. 21a-254-6. Management of information

Latest version.

The department may provide prescription information obtained from pharmacies to:

(a) Other regulatory, investigative or law enforcement agencies for disciplinary, civil, or criminal purposes;

(b) Practitioners, for the purpose of education in lieu of disciplinary, civil or criminal action;

(c) Practitioners and pharmacists, for the purposes of patient care, drug therapy management and monitoring of controlled substances obtained by the patient; and

(d) Public or private entities, for statistical, research, or educational purposes, provided that the privacy of patients and confidentiality of patient information is not compromised.

(Adopted effective August 1, 2007)

Sec. 21a-254-7. Storage of information

Latest version.

(a) The department shall ensure the privacy of patients and confidentiality of patient information transmitted or obtained pursuant to sections 21a-254-2 to 21a-254-6, inclusive, of the Regulations of Connecticut State Agencies, and shall ensure that the patient information collected, recorded, transmitted, and stored is maintained in accordance with applicable state and federal laws, rules and regulations.

(b) The department shall retain the prescription information collected pursuant to sections 21a-254-2 to 21a-254-6, inclusive, of the Regulations of Connecticut State Agencies,for a minimum of three years.

(Adopted effective August 1, 2007)