§ 17b-363a — Return of unused prescription drugs dispensed in long-term care facilities to vendor pharmacies. Requirements. Regulations. Fines. Annual list of drugs in program.

Connecticut § 17b-363a

• Jurisdiction: Connecticut
• Title 17b: Social Services
• Ch. 319y: Long-Term Care

Text

(a) Each long-term care facility shall return to the vendor pharmacy which shall accept, for repackaging and reimbursement to the Department of Social Services, drug products that were dispensed to a patient and not used if such drug products are (1) prescription drug products that are not controlled substances, (2) sealed in individually packaged units, (3) returned to the vendor pharmacy within the recommended period of shelf life for the purpose of redispensing such drug products, (4) determined to be of acceptable integrity by a licensed pharmacist, and (5) oral and parenteral medication in single-dose sealed containers approved by the federal Food and Drug Administration, topical or inhalant drug products in units of use containers approved by the federal Food and Drug Administration or parenteral medications in multiple-dose sealed containers approved by the federal Food and Drug Administration from which no doses have been withdrawn. (b) Notwithstanding the provisions of subsection (a) of this section: (1) If such drug products are packaged in manufacturer's unit-dose packages, such drug products shall be returned to the vendor pharmacy for redispensing and reimbursement to the Department of Social Services if such drugs may be redispensed for use before the expiration date, if any, indicated on the package. (2) If such drug products are repackaged in manufacturer's unit-dose or multiple-dose blister packs, such drug products shall be returned to the vendor pharmacy for redispensing and reimbursement to the Department of Social Services if (A) the date on which such drug product was repackaged, such drug product's lot number and expiration date are indicated clearly on the package of such repackaged drug; (B) ninety days or fewer have elapsed from the date of repackaging of such drug product; and (C) a repackaging log is maintained by the pharmacy in the case of drug products repackaged in advance of immediate needs. (3) No drug products dispensed in a bulk dispensing container may be returned to the vendor pharmacy. (c) Each long-term care facility shall establish procedures for the return of unused drug products to the vendor pharmacy from which such drug products were purchased. (d) The Department of Social Services (1) shall reimburse to the vendor pharmacy the reasonable cost of services incurred in the operation of this section, as determined by the commissioner, and (2) may establish procedures, if feasible, for reimbursement to non Medicaid payors for drug products returned pursuant to this section. (e) The Department of Consumer Protection, in consultation with the Department of Social Services, shall adopt regulations, in accordance with the provisions of chapter 54, which shall govern the repackaging and labeling of drug products returned pursuant to subsections (a) and (b) of this section. The Department of Consumer Protection shall implement the policies and procedures necessary to carry out the provisions of this section until January 1, 2002, while in the process of adopting such policies and procedures in regulation form, provided notice of intent to adopt the regulations is published in the Connecticut Law Journal within twenty days after implementation. (f) Any long-term care facility that violates or fails to comply with the provisions of this section shall be fined not more than thirty thousand dollars for each incidence of noncompliance. The Commissioner of Social Services may offset payments due a facility to collect the penalty. Prior to imposing any penalty pursuant to this subsection, the commissioner shall notify the long-term care facility of the alleged violation and the accompanying penalty and shall permit such facility to request that the department review its findings. A facility shall request such review not later than fifteen days after receipt of the notice of violation from the department. The department shall stay the imposition of any penalty pending the outcome of the review. The commissioner may impose a penalty upon a facility pursuant to this subsection regardless of whether a change in ownership of the facility has taken place since the time of the violation, provided the department issued notice of the alleged violation and the accompanying penalty prior to the effective date of the change in ownership and record of such notice is readily available in a central registry maintained by the department. Payments of fines received pursuant to this subsection shall be deposited in the General Fund and credited to the Medicaid account. (g) The Commissioner of Social Services shall update and expand by June 30, 2003, and annually thereafter, the list of drugs that are included in the drug return program. Such list shall include the fifty drugs with the highest average wholesale price that meet the requirements for the program, as established in subsection (a) of this section.

Legislative History

(June Sp. Sess. P.A. 00-2, S. 37, 53; May 9 Sp. Sess. P.A. 02-1, S. 119; P.A. 03-116, S. 1; June 30 Sp. Sess. P.A. 03-6, S. 146(d); P.A. 04-169, S. 17; 04-189, S. 1; 04-258, S. 28; P.A. 11-25, S. 16.) History: June Sp. Sess. P.A. 00-2 effective July 1, 2000; May 9 Sp. Sess. P.A. 02-1 added new Subsec. (f) re imposition of fine for violation or failure to comply with section, effective July 1, 2002; P.A. 03-116 added Subsec. (g) re annual list of drugs included in program, effective June 18, 2003; June 30 Sp. Sess. P.A. 03-6 and P.A. 04-169 replaced Department of Consumer Protection with Department of Agriculture and Consumer Protection, effective July 1, 2004; P.A. 04-189 repealed Sec. 146 of June 30 Sp. Sess. P.A. 03-6, thereby reversing the merger of the Departments of Agriculture and Consumer Protection, effective June 1, 2004; P.A. 04-258 amended Subsec. (f) by changing amount of fine from $30,000 to “not more than” $30,000 and making technical changes, effective July 1, 2004; P.A. 11-25 amended Subsec. (g) by deleting provision re consultation with pharmacy review panel.