Wyo. Code R. 048-0044-2
Effective Date: 05/25/2021 to Current
Rule Type: Current Rules & Regulations
Reference Number: 048.0044.2.05252021
Section 1. Authority. This Chapter is promulgated by the Department of Health pursuant to the Drug Donation Program Act, at Wyoming Statues §§ 35-7-1601 through 35-7-1606.
(a) This Chapter has been adopted to govern the process and procedures pertaining to the Wyoming Medication Donation Program (Program), including but not limited to, eligibility, site requirements, and donation criteria.
(b) The Department may issue manuals, bulletins, and/or forms to interpret the sections of this Chapter. Such manuals, bulletins, and forms shall be consistent with and reflect the rules contained in this Chapter. The provisions contained in manuals, bulletins, or forms shall be subordinate to the sections of this Chapter.
(a) Nothing in this Chapter shall be construed as providing an individual with an entitlement to this program.
(b) Donated medications shall be dispensed upon a valid prescription of a licensed health care practitioner.
(c) Hard or electronic copies of all prescriptions dispensed shall be maintained by the facility where the dispensing occurred.
(d) If a medication is recalled and there is no lot number on the label to differentiate between the recalled and non-recalled drug, it shall be assumed part of the recall and all such donated medications shall be destroyed and documented using standard procedures.
(e) Any location dispensing donated medications shall verify recipient eligibility and retain all records of eligibility for at least two (2) years and shall use application forms provided by the program.
(a) 'Central collection facility.' Refers to the program's main location where all donated medications are processed before being dispensed directly to a recipient or given to a participating dispensing site for dispensing.
(b) “Dispense.” Means to deliver a drug to an ultimate user by or pursuant to the lawful order of a practitioner, including the prescribing, administration, packaging, or labeling necessary to prepare the substance for that delivery.
(c) “Health care professional.” A person who holds a certification, license, or registration in a health care field of practice, including but not limited to, dentists, nurses, nurse practitioners, pharmacists, pharmacy technicians, medical assistants, practitioners, physician assistants, occupational therapists, and psychiatrists.
(d) “Practitioner.” A person licensed to offer health care services who is authorized to issue prescriptions.
(e) “Recipient.” Refers to an individual who receives donated medications.
(f) “Site.” Refers to a physician, pharmacy, or health care facility that participates in the program to collect donated medications (donation site) or dispense donated medications (dispensing site). Sites shall be located within Wyoming.
(a) A participating site may either be a donation site or a dispensing site, or both.
(b) A participating site may withdraw at any time upon written notification to the program and any contracts, agreements, or memorandum of understanding between the Department and the site shall be rendered terminated.
(c) It is the responsibility of the participating site to notify the program of any contact information changes, including but not limited to, primary contact person, site business name, address, telephone number, and e-mail (if available).
(d) Participating sites may register with the program and registration will be renewed annually in June.
(a) The medication packaging shall not have any physical signs of tampering.
(b) The expiration date of the medication shall be one (1) year from the original dispensed date, if no expiration date is listed on the medication.
(i) If no expiration date or original dispense date can be identified, the medication shall not be accepted for donation.
(c) Controlled substances, temperature sensitive medications, and compounded medications shall not be donated to the program, except when the program obtains the donated medication directly from the manufacturer.
(a) Participating donation sites shall collect donated medication and ensure that donor forms are completed. All acceptable donated medications shall be shipped to the central collection facility for processing.
(b) The participating donation site shall ensure that donated medications are kept separate from normal stock in a secure location.
(c) Identifying information on the medication label, such as patient name and prescription number, will be obliterated from the packaging by the participating donation site.
(i) Drug related information, including but not limited to, drug name and strength, expiration date and/or original dispensed date, lot number, NDC number, and quantity, shall remain visible on the medication packaging.
(d) Donated non-controlled substances that are not suitable for dispensing shall be destroyed or returned to the original donor.
(i) Destruction shall be performed by a health care professional and documented.
(ii) If accepted in error, controlled substances shall be destroyed or returned to the original donor. Two individuals (at least one health care professional) shall witness and document the destruction of any controlled substances.
(a) Participating dispensing sites shall be responsible for any costs associated with the dispensing process of donated medication stock received from the central collection facility.
(b) Sample medications shall be acquired from the central collection facility in its original packaging as required under federal law.
(c) Donated medication stock from the program that cannot be dispensed shall be destroyed or disposed of according to the site’s protocols.
(a) A recipient shall meet the following requirements to be eligible to receive donated medication from the program:
(v) Recipients shall notify the location that dispensed the recipient the donated medication of any changes to the following:
(A) Address or phone number.
(a) Sites shall keep records in conformance with the record keeping requirements of the program, and all applicable federal and state laws, rules, and regulations.
(b) Destruction forms shall be kept of unacceptable donated medications for two (2) years by the site.
(c) Any location that dispenses donated medications shall maintain records of recipient eligibility, prescriptions dispensed, and handling fees collected for two (2) years.
(i) Dispensing sites shall report statistical information to the program. Sites that do not report are subject to termination of participation as determined by the program.
(ii) Dispensing sites are subject to recipient applications, dispensed prescriptions, and handling fee record audits from the program upon the program's request.
(A) Audit requests shall be made in writing and the dispensing site shall have up to thirty (30) days from the date of the written request to produce items to the program for review.
(B) Failure to produce audit items may result in termination of participation as determined by the program.
(a) Forms will be provided by the program to be utilized by participating sites, donors, or recipients. This includes, but is not limited to, the following form types.
(a) Handling fee may be charged to the recipient to whom the donated medication is dispensed. The handling fee shall be determined by the program to cover dispensing or distributing costs per prescription.
(b) Donated medications and supplies may not be sold.
(c) Participating dispensing sites shall obtain approval from the program prior to collecting handling fees from recipients.
(a) Over-the-Counter medications may be accepted for donation.
(b) Medical supplies, including but not limited to, bandages, drainage bags, syringes, and medical tubing, shall not be accepted for donation to the program.
(a) The program shall establish and maintain a participating site registry.
(i) The registry shall include the participating site name, site type, address, and telephone number.
(ii) The registry shall be posted on the program's website for public view.