FIRST REGULAR SESSION
SENATE BILL NO. 559
91ST GENERAL ASSEMBLY
INTRODUCED BY SENATOR SINGLETON.
Read 1st time February 27, 2001, and 1,000 copies ordered printed.
TERRY L. SPIELER, Secretary.
1791S.01I
AN ACT
To amend chapter 208, RSMo, by adding thereto one new section relating to the return of pharmaceuticals, with an expiration date.
Section A. Chapter 208, RSMo, is amended by adding thereto one new section, to be known as section 208.554, to read as follows:
208.554. 1. Any long-term care facility serving Medicaid patients shall return to the vendor pharmacy, which shall accept for repacking and reimbursement to the department of social services, drug products that were dispensed to a Medicaid 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in multiple-dose sealed containers approved by the federal Food and Drug Administration from which no doses have been withdrawn.
2. Notwithstanding the provisions of subsection 1 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.
3. Each long-term care facility to which this section applies shall establish procedures for the return of unused drug products to the vendor pharmacy from which such drug products were purchased.
4. 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 director; and
(2) May establish procedures, if feasible, for reimbursement to non-Medicaid payors for drug products returned pursuant to this section.
5. The department of social services, shall adopt regulations, in accordance with the provisions of this chapter, which shall govern the repackaging and labeling of drug products returned pursuant to subsections 1 and 2 of this section. The department of social services shall promulgate rules to implement the policies and procedures necessary to carry out the provisions of this section until January 1, 2002. Any rule or portion of a rule, as that term is defined in section 536.010, RSMo, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536, RSMo, and, if applicable, section 536.028, RSMo. This section and chapter 536, RSMo, are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536, RSMo, to review, to delay the effective date or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2001, shall be invalid and void.