§ 20-617b — Compliance packaging. Requirements. Regulations.

(a)(1) A pharmacist or advanced pharmacy technician may, at the request of a patient, the patient's representative or the patient's prescribing practitioner, dispense to the patient compatible drugs in compliance packaging. (2) (A) If a patient's prescribing practitioner modifies the patient's prescription or prescriptions by, among other things, issuing any new prescription or discontinuing or deprescribing any drug that was previously dispensed to the patient in compliance packaging, the pharmacy that first dispensed such previously dispensed drug in such compliance packaging may, at the request of such patient, representative or prescribing practitioner and if such pharmacy documents such modification in writing, (i) accept such compliance packaging from such patient or representative, (ii) receive and remove any drugs from such returned compliance packaging and redispense such drugs to such patient, and (iii) dispense any newly prescribed and compatible drugs in the redispensed compliance packaging. (B) Any pharmacy that accepts any compliance packaging returned under this subdivision shall do so exclusively to (i) dispense to the patient any compatible drugs that are newly prescribed to such patient, and (ii) redispense to the patient any drugs contained in such returned compliance packaging in the same quantities that were contained in such returned compliance packaging when such pharmacy accepted such returned compliance packaging. (C) Each pharmacy that redispenses any drug contained in any compliance packaging returned under this subdivision shall redispense such drug to the patient in (i) compliance packaging that exclusively contains drugs currently prescribed to such patient, or (ii) a separate container that is labeled in accordance with the provisions of section 20-617 and subparagraph (D) of this subdivision. (D) If a pharmacy accepts any compliance packaging returned under this subdivision and such returned compliance packaging contains one or more drugs that have been deprescribed, discontinued or have otherwise been deemed to be inappropriate for inclusion in compliance packaging, as determined by the patient's prescribing practitioner or a pharmacist, the pharmacy shall redispense such drugs to the patient in one or more separate containers, each of which shall (i) include not more than one drug type or dosage, and (ii) bear a label that includes the patient's name, the original prescription serial number or serial numbers, the drug name or names, the dosage form or forms, the quantity or quantities redispensed and instructions for use or disposal, as applicable, which instructions shall disclose, at a minimum, (I) the procedures for any lawfully available means of destroying such drug or drugs at home, and (II) the nearest location where such drug or drugs may be deposited for destruction, including, but not limited to, the nearest retail location allowed to accept such drug or drugs under the regulations adopted pursuant to section 20-576a . (E) No pharmacy, pharmacist, pharmacy intern or advanced pharmacy technician shall return to a pharmacy's general inventory or regular stock any returned drug that was previously contained in any compliance packaging returned under this subdivision, unless accepting such drug for return to the pharmacy's general inventory or regular stock is otherwise permitted or required by law. (b) Compliance packaging shall: (1) Exclusively contain (A) individual compartments that are tamper-evident, and (B) drugs that (i) are currently prescribed to a single patient pursuant to an order or prescription by the patient's prescribing practitioner, and (ii) dispensed or redispensed to a single patient by a pharmacist or an advanced pharmacy technician; (2) Be labeled or relabeled by a pharmacist in accordance with the provisions of section 20-617 , except if the compliance packaging contains an opioid drug, as defined in section 20-14o , only one sticker or label shall be affixed to such compliance packaging pursuant to section 20-636 and not to each individual compartment contained in such compliance packaging; (3) Be child-resistant unless the pharmacy provides to the patient, and the patient acknowledges and returns to the pharmacy, a waiver explaining that the drugs contained in the compliance packaging are not in a child-resistant container; (4) Identify, on each individual compartment, the name and strength of the drug or drugs contained in such compartment; (5) Not contain more than a ninety-day supply of any drug, as prescribed, except as otherwise provided in any applicable state or federal law; and (6) Be compliant with all applicable provisions of the United States Pharmacopeia, as amended from time to time. (c) (1) An individual compartment of compliance packaging may contain multiple prescribed drugs, provided: (A) A pharmacist has determined that all drugs contained in such compartment are compatible drugs; (B) All drugs contained in such compartment are subject to the same instructions concerning time of administration; and (C) No drug contained in such compartment has instructions for use that permit such drug to be used on an as needed basis. (2) No controlled substance shall be contained in any compliance packaging that contains any other drug, unless such other drug is a controlled substance of the same drug type prescribed at a different dose. (d) A pharmacy that provides compliance packaging services shall: (1) Maintain an area dedicated to the preparation of drugs that are to be dispensed or redispensed in compliance packaging, which area shall include all equipment necessary to: (A) Ensure that all compliance packaging is accurately prepared; and (B) Prevent any contamination of such drugs; (2) Maintain standard operating procedures: (A) For the use of compliance packaging and associated equipment, which procedures shall include, at a minimum, provisions concerning (i) inspections of compliance packaging integrity, (ii) cleaning, (iii) labeling, (iv) dispensing and redispensing, (v) proper hand hygiene, (vi) quarantine, and (vii) handling of dispensed drugs that are removed from compliance packaging and redispensed to patients in the manner set forth in subdivision (2) of subsection (a) of this section; and (B) That specify which drugs (i) are not compatible drugs, (ii) are suitable to be dispensed or redispensed in compliance packaging, or (iii) require special consideration to be dispensed or redispensed in compliance packaging; and (3) Maintain the following records: (A) A record of all drugs that the pharmacy dispenses to a patient in compliance packaging, which record shall include at least the following for each such drug: (i) The patient's name and address; (ii) The identification number, if any, for the compliance packaging in which such pharmacy dispensed such drug, the date such compliance packaging was prepared, the initials of the individual who prepared such compliance packaging and the initials of the individual who performed a final verification for such compliance packaging; (iii) The name, strength, lot number and national drug code number for such drug; (iv) The serial number of the prescription for such drug; and (v) A visual description of such drug; (B) A record of all items of compliance packaging that the pharmacy accepts from a patient for return and redispensing to the patient in the manner set forth in subdivision (2) of subsection (a) of this section, which record shall include at least the following for each such item of compliance packaging: (i) The patient's name and address; (ii) The identification number, if any, for such item of compliance packaging; (iii) The date on which such pharmacy accepted such item of compliance packaging for return and redispensing in such manner; (iv) The name of the pharmacist or pharmacy technician who documented the return of such item of compliance packaging; and (v) The name, formulation and quantity of each drug contained in such item of compliance packaging when such pharmacy accepted such item of compliance packaging for return and redispensing in such manner, including a designation disclosing whether any such drug was deprescribed if the patient's prescribing practitioner has discontinued the prescription; (C) A record of all items of compliance packaging in which the pharmacy redispenses any drug to a patient in the manner set forth in subdivision (2) of subsection (a) of this section, which record shall include at least the following for each such item of compliance packaging: (i) The patient's name and address; (ii) The identification number, if any, for such item of compliance packaging; (iii) The date such item of compliance packaging was prepared for redispensing in such manner; (iv) The serial number of the prescription for each drug redispensed in such item of compliance packaging in such manner; (v) The name, formulation and quantity of each drug redispensed in such item of compliance packaging in such manner; (vi) The name or initials of the redispensing pharmacist; (vii) The initials of the individual who prepared such item of compliance packaging for redispensing in such manner; and (viii) The initials of the individual who performed a final verification for such item of compliance packaging for redispensing in such manner; and (D) A record of all drugs that the pharmacy redispenses to a patient in any container, other than compliance packaging, in the manner set forth in subdivision (2) of subsection (a) of this section, which record shall include at least the following for each such drug: (i) The patient's name and address; (ii) The date such drug was prepared for redispensing in such container in such manner; (iii) The serial number of the prescription for such drug; (iv) The name and formulation of such drug and the quantity of such drug that was redispensed in such container in such manner; and (v) The name or initials of the redispensing pharmacist. (e) Each pharmacy shall maintain all records that such pharmacy is required to maintain pursuant to this section for a period of at least three years. Not later than forty-eight hours after the department requests that a pharmacy disclose a copy of any record the pharmacy is required to maintain pursuant to this section, such pharmacy shall disclose such copy to the department in electronic form or, if such pharmacy is unable to disclose such copy in electronic form, in paper form. (f) The commissioner may adopt regulations, in accordance with the provisions of chapter 54, to implement the provisions of this section.

Legislative History

(P.A. 24-73, S. 4.)