SP0538, LD 1661, item 1, An Act To Create the Drug Donation and Redispensing Program

An Act To Create the Drug Donation and Redispensing Program

Be it enacted by the People of the State of Maine as follows:

Sec. 1. 22 MRSA §2700, sub-§§3 and 4, as amended by PL 2013, c. 121, §1, are further amended to read:

3. Return of pharmaceuticals. The agency may create systems for the safe, effective and proper disposal of unused pharmaceuticals. The systems may include the use of prepaid mailing envelopes into which the unused pharmaceuticals are placed and returned to a single collection location. The prepaid mailing envelopes must be made available to the public at various locations, including, but not limited to, pharmacies, physicians' offices and post offices. The agency may randomly assess the toxicity of materials received under the program as long as the assessment results do not identify the patient, person who mailed the material, prescriber or pharmacy. The agency shall consult with the department to determine the suitability of unused pharmaceuticals for donation to the drug donation and redispensing program under section 2700-B and transfer suitable pharmaceuticals to the drug donation and redispensing program.

4. Disposal of pharmaceuticals. All Except for pharmaceuticals donated to the drug donation and redispensing program under subsection 3, all unused pharmaceuticals received under the program must be disposed of in a manner that is designed to be effective, secure and in compliance with local, state and federal environmental requirements, including the federal Resource Conservation and Recovery Act of 1976, as amended.

Sec. 2. 22 MRSA c. 606 is enacted to read:

CHAPTER 606

DRUG DONATION AND REDISPENSING PROGRAM

§ 2700-B. Drug donation and redispensing program

1. Program established. The department shall establish a drug donation and redispensing program, referred to in this chapter as "the program." For purposes of this chapter, "drug" means a prescription drug or legend drug under Title 32, section 13702-A, subsection 30.

2. Program components. To the extent authorized by federal law, components of the program include:

A. Any person, including a drug manufacturer, licensed physician, pharmacy, health care facility licensed under this Title or the Unused Pharmaceutical Disposal Program under section 2700, may donate a drug to the program;

B. A drug may be donated at:

(1) A donation site provided by the department under subsection 4, paragraph A;

(2) A take-back event approved by the United States Department of Justice, Drug Enforcement Administration; or

(3) A pharmacy, licensed health care provider's or professional's office or a licensed health care facility that elects to participate in the program and meets criteria established by the department under subsection 4, paragraph E;

C. The program may redispense a donated drug only if the drug is in the drug's original, unopened, sealed packaging or, if the outside packaging is opened or disturbed, the contents are one or more single-unit doses that are individually contained in unopened, tamper-evident packaging;

D. The program may not redispense a donated drug if the drug is within 2 months of the drug's expiration date, if the drug appears to be adulterated or misbranded or if the drug is a scheduled drug as defined in Title 17-A, section 1101, subsection 11;

E. The program shall inventory all drugs donated and deliver the drugs to a pharmacy that elects to participate in the program and meets criteria established by the department under subsection 4, paragraph F; and

F. A pharmacy shall dispense a drug under paragraph E to a qualified recipient under subsection 3 and may charge the recipient a handling fee.

3. Qualifications of recipients. A person is a qualified recipient and may receive a donated drug from a pharmacy under subsection 2, paragraph E if the person has a family income equal to or less than 350% of the federal poverty level, the person's family incurs unreimbursed expenses for drugs that equal 5% or more of family income or the person's total unreimbursed medical expenses equal 15% or more of family income. For purposes of this subsection, "federal poverty level" means that measure defined by the federal Department of Health and Human Services and updated annually in the Federal Register under authority of 42 United States Code, Section 9902(2).

4. Department duties. The department shall:

A. Provide donation sites in locations convenient to consumers throughout the State;

B. Implement by rule procedures for the documentation of all donated drugs;

C. Implement by rule procedures for the transfer to the Unused Pharmaceutical Disposal Program under section 2700 of all drugs determined unfit for redispensing;

D. Provide for public education of the availability of the program, including the location of donation sites and pharmacies that participate in the redispensing of the drugs;

E. Implement by rule procedures by which a person can participate as a donor in the program;

F. Implement by rule procedures by which a pharmacy can participate as a dispenser of donated drugs under the program; and

G. Administer the program.

5. Rules. The department may adopt rules to carry out the purposes of the program. Rules adopted pursuant to this subsection are routine technical rules as defined by Title 5, chapter 375, subchapter 2-A.

SUMMARY

This bill establishes the drug donation and redispensing program under the Department of Health and Human Services. The program collects donations of unused prescription and legend drugs from health care providers, health care facilities and other sources, including at drop-off locations throughout the State, and redispenses the drugs through participating pharmacies to qualified low-income persons.

SP0538 LD 1661	Session - 129th Maine Legislature		LR 2470 Item 1
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