Kentucky Administrative Regulations
Title 201 - GENERAL GOVERNMENT CABINET
Chapter 2 - Board of Pharmacy
Section 201 KAR 2:240 - Special limited pharmacy permit - Charitable
Universal Citation: 201 KY Admin Regs Service 2:240
Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO: KRS 315.035
NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) authorizes the board to promulgate administrative regulations to prescribe the criteria for obtaining a pharmacy permit to dispense legend drugs and the procedures for the safe dispensing of legend drugs to citizens of the Commonwealth. This administrative regulation identifies the manner and procedure by which a charitable organization may obtain a pharmacy permit and dispense legend drugs in the Commonwealth.
Section 1. Definitions.
(1) "Charitable organization"
means an organization qualified as a charitable organization pursuant to
Section 501(c)(3) of the Internal Revenue Code,
26 U.S.C.
501(c)(3).
(2) "Legend drug sample" means an unopened
package of a manufacturer's legend drug product that has been distributed to
either a practitioner or the charitable pharmacy in accordance with the
provisions of the Prescription Drug Marketing Act of 1987, 21 C.F.R. Part
203.
(3) "Qualified indigent
patient" means a patient of the charitable pharmacy that has been screened and
approved by the charitable organization as meeting the organization's mission
of providing pharmaceutical care to those who are without sufficient funds to
obtain needed legend drugs.
(4)
"Special limited pharmacy permit" means a permit issued to a pharmacy that
provides specialized pharmacy services, such as dispensing legend drugs, and
counseling patients.
Section 2.
(1) A charitable pharmacy:
(a) Shall comply with all pharmacy permit
requirements except those specifically exempted by the board pursuant to
paragraph (b) of this subsection; and
(b) May petition the board in writing to be
exempted from those pharmacy permit requirements that do not pertain to the
operation of that charitable pharmacy.
(2) The charitable pharmacy only shall
dispense prescription legend drug samples or prescription legend drugs to
qualified indigent patients of the pharmacy.
(3) The charitable pharmacy shall not charge
any fee for the dispensing of prescription legend drug samples or prescription
legend drugs to qualified indigent patients of the pharmacy.
(4) A charitable pharmacy may accept
prescription legend drugs in their unbroken original packaging from pharmacies,
wholesalers, or manufacturers, provided appropriate records of receipt and
dispensing are maintained.
(5) A
charitable pharmacy shall not:
(a) Accept
controlled substances from pharmacies, wholesalers, or manufacturers;
or
(b) Dispense controlled
substances.
(6) A
pharmacy that requests a special limited pharmacy permit - charitable shall
submit to the board for prior approval, a plan describing the method by which
the charitable pharmacy and the pharmacy shall maintain a separate and distinct
prescription drug stock. The failure of either pharmacy to follow the plan
shall result in revocation of the special limited pharmacy permit - charitable
and the pharmacy permit.
Section 3. License Fees; Renewals. An applicant shall submit:
(1) An initial or renewal application for a
special limited pharmacy permit - charitable pharmacy on either the:
(a)
1.
Application for Resident Special Limited Pharmacy Permit - Charitable Pharmacy;
or
2. Application for Resident
Special Limited Pharmacy Permit - Charitable Pharmacy Renewal; or
(b)
1. Application for Non-Resident Special
Limited Pharmacy Permit - Charitable Pharmacy; or
2. Application for Non-Resident Special
Limited Pharmacy Permit - Charitable Pharmacy Renewal; and
(2) As appropriate, the:
(a) Initial application fee established by
201 KAR 2:050, Section 1(8);
or
(b) Renewal fee established by
201 KAR 2:050, Section 1(9) and
(10).
Section 4. Incorporation By Reference.
(1) The following material is incorporated by
reference:
(a) "Application for Resident
Special Limited Pharmacy Permit - Charitable Pharmacy", June 2023;
(b) "Application for Resident Special Limited
Pharmacy Permit - Charitable Pharmacy Renewal", June 2023.
(c) "Application for Non-Resident Special
Limited Pharmacy Permit - Charitable Pharmacy", September 2023; and
(d) "Application for Non-Resident Special
Limited Pharmacy Permit-Charitable Pharmacy Renewal", September 2023.
(2) This material may be
inspected, copied, or obtained, subject to applicable copyright law, at the
Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, Frankfort, Kentucky
40601, Monday through Friday, 8 a.m. to 4:30 p.m. This material is also
available on the board's Web site at
https://pharmacy.ky.gov/Businesses/Pages/Pharmacy.aspx .
STATUTORY AUTHORITY: KRS 315.020, 315.030, 315.035, 315.191(1)(a)
Disclaimer: These regulations may not be the most recent version. Kentucky may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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