Kentucky Administrative Regulations
Title 201 - GENERAL GOVERNMENT CABINET
Chapter 2 - Board of Pharmacy
Section 201 KAR 2:225 - Special limited pharmacy permit - Medical gas
Universal Citation: 201 KY Admin Regs Service 2:225
Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS 217.015(11), 315.010(9), 315.020, 315.035, 315.191(1)(a)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) authorizes the board to promulgate administrative regulations to regulate and control all matters set forth in KRS Chapter 315 relating to pharmacists and pharmacies. This administrative regulation establishes, consistent with the requirements of KRS 315.191(1)(a), minimum requirements for the permitting of those entities that distribute medical gases.
Section 1. Definitions.
(1) "Medical gases" means gases (including
liquefied gases) classified by FDA as drugs or devices that are used for
medical applications and which may be stored and administered through the use
of Medical Gas Related Equipment, which may or may not be required under
Federal or State law for the immediate container to bear the label, "Rx only"
or "Caution: Federal or State law prohibits dispensing without a
prescription."
(2) "Special limited
pharmacy permit" means a permit issued to a pharmacy that provides
miscellaneous specialized pharmacy service and functions.
Section 2. General Requirements.
(1)
(a) An
applicant for a special limited pharmacy permit for medical gases shall comply
with the requirements of
201 KAR 2:180, except Section 5
and 201 KAR 2:205, except that the
pharmacist-in-charge designated on the special permit shall be exempt from the
requirements of
201 KAR 2:205, Section
2(2).
(b) The pharmacist-in-charge
shall review the records and do an onsite visit of the special limited pharmacy
permit for medical gases not less than once each quarter.
(2) An applicant for a special limited
pharmacy permit for medical gases shall prepare and adopt a policy and
procedures manual that sets forth a detailed description of how the:
(a) Operation will comply with applicable
federal, state, or local laws or administrative regulations; and
(b) Licensee will maintain the premises so
that the medical gas remains secure and complies with applicable compendial
monographs of official pharmacopoeias.
(3) An applicant for a special limited
pharmacy permit for medical gases shall be inspected by the board prior to the
issuance of the license.
Section 3. Qualifications for License.
(1) The board shall consider the following in
reviewing the qualifications of an applicant for a special limited pharmacy
permit for medical gases:
(a) The applicant's
experience in the sale or distribution of prescription drugs, including
controlled substances;
(b) A felony
conviction of the applicant under federal, state, or local laws;
(c) The furnishing by the applicant of false
or fraudulent material in a previous application for:
1. A special limited pharmacy permit for
medical gases; or
2. A federal or
state medical assistance program;
(d) Suspension or revocation of an
applicant's license or permit by federal, state, or local government;
and
(e) Compliance with
requirements under a previously granted license or permit.
(2) The board shall deny an application for a
special limited pharmacy permit for medical gases, if an applicant has:
(a) Been convicted for a violation of
federal, state, or local laws relating to:
1.
The practice of pharmacy;
2. Drugs;
or
3. Federal or state medical
assistance programs.
(b)
Furnished false or fraudulent material in the application for a special limited
pharmacy permit for medical gases;
(c) Failed to maintain or make available
required records to the:
1. Board;
or
2. Federal, state, or local law
enforcement officials;
(d) Failed to comply with applicable federal,
state, and local laws and regulations relating to medical gas; or
(e) Failed to provide appropriate land,
buildings, and security necessary to properly carry on the business described
in his or her application.
Section 4. License Fees; Renewals. An applicant shall submit:
(1) An initial or
renewal application for a special limited pharmacy permit for medical gases on
either the:
(a)
1. Application for Special Limited Pharmacy
Permit - Medical Gas; or
2.
Application for Special Limited Pharmacy Permit - Medical Gas Renewal;
or
(b)
1. Application for Nonresident Special
Limited Pharmacy Permit - Medical Gas; or
2. Application for Nonresident Special
Limited Pharmacy Permit - Medical Gas 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).
Section 5. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) "Application for Special
Limited Pharmacy Permit - Medical Gas", June 2023; and
(b) "Application for Special Limited Pharmacy
Permit - Medical Gas Renewal", June 2023;
(c) "Application for Nonresident Special
Limited Pharmacy Permit - Medical Gas", September 2023; and
(d) "Application for Nonresident Special
Limited Pharmacy Permit - Medical Gas 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
40601-8204, 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, 315.035, 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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