Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
217.055(1),
217.065(7),
315.020(1),
315.035(6),
315.0351,
315.121,
315.191(1)(a),
(g),
21 U.S.C.
353A,
21 C.F.R.
216.23
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
315.020(1) requires the
owner of a pharmacy who is not a pharmacist to place a pharmacist in charge of
the owner's pharmacy.
KRS
315.035(6) authorizes the
board to promulgate administrative regulations to assure that proper equipment
and reference material is on hand considering the nature of the pharmacy
practice conducted at the particular pharmacy and to assure reasonable health
and safety standards for areas within the pharmacies, which are not subject to
these standards under CHFS.
KRS
315.191(1) authorizes the
board to promulgate administrative regulations necessary to regulate and
control all matters relating to pharmacists, pharmacist interns, pharmacy
technicians, pharmacies, wholesale distributors, and manufacturers. This
administrative regulation establishes the requirements for compounding
non-sterile and sterile preparations, and the preparation, compounding,
dispensing, and repackaging of radiopharmaceuticals in accordance with
21 U.S.C.
353A.
Section
1. Definitions.
(1) "API" means
active pharmaceutical ingredient.
(2) "Designated person" means one (1) or more
individuals assigned to be responsible and accountable for the performance and
operation of the facility and personnel as related to the preparation of
compounded non-sterile or sterile preparations or the preparation, compounding,
dispensing, and repackaging of radiopharmaceuticals.
(3) "Essential copy of a commercially
available drug product" is a compounded preparation in which:
(a) The compounded preparation has the same
API as the commercially available drug product;
(b) The APIs have the same, similar, or an
easily substitutable dosage strength; and
(c) The commercially available drug product
can be used by the same route of administration as prescribed for the
compounded preparations, unless a prescriber determines that there is a change,
made for an identified individual patient, which produces, for that patient, a
significant difference from the commercially available drug product.
(4) "Hazardous Drug" means any
drug identified by the National Institute for Occupational Safety and Health
with at least one (1) of the following criteria:
(a) Carcinogenicity, teratogenicity, or
developmental toxicity;
(b)
Reproductive toxicity in humans;
(c) Organ toxicity at low dose in humans or
animals;
(d) Genotoxicity;
or
(e) New drugs that mimic
existing hazardous drugs in structure or toxicity.
(5) "USP" means United States
Pharmacopeia.
Section 2.
Policies and Procedures.
(1) A policy and
procedure manual for non-sterile and sterile compounding shall be readily
available at a pharmacy for inspection purposes.
(2) The policy and procedure manual shall be
made available to the board upon request.
(3) The manual shall be reviewed and revised
on an annual basis.
Section
3. Standards.
(1) All non-sterile
compounded preparations shall be compounded pursuant to USP 795.
(2) All sterile compounded preparations shall
be compounded pursuant to USP 797.
(3) All preparation, compounding, dispensing,
and repackaging of radiopharmaceuticals shall be pursuant to USP 825.
(4) All non-sterile or sterile compounded
preparations containing hazardous drugs shall be compounded pursuant to USP
800, unless specified portions submitted by a pharmacy have been waived by the
board.
(5) Non-sterile and sterile
preparations compounded for human use shall:
(a)
1.
Comply with the standards of an applicable USP or National Formulary
monograph;
2. Be compounded from a
component of a human drug approved by the United States Food and Drug
Administration (FDA); or
3. Be
compounded from a component that appears on the FDA's list of bulk drug
substances established in 21
C.F.R. 216.23 that can be used in
compounding; and
(b) Not
be essential copies of a commercially available drug product unless authorized
by 21 U.S.C.
353(a).
Section 4. Designated Person.
(1) The designated person of a facility that
compounds non-sterile or sterile preparations or prepares, compounds,
dispenses, or repackages radiopharmaceuticals shall be knowledgeable in the
specialized requirements of preparing and dispensing compounded
preparations.
(2) The PIC shall
serve or appoint any designated person.
(3) The PIC shall ensure any compounded
preparation leaving the premises is shipped or delivered in a manner that
maintains the integrity and stability of the preparation.
Section 5. Dispensing and Labeling.
(1) The pharmacist shall receive a written,
electronic, facsimile, or verbal prescription, or medical order from a
prescriber before dispensing any compounded, non-sterile or sterile
preparation. These prescriptions or medical orders shall contain the following:
(a) Patient's name and species, if not
human;
(b) Patient's address on
controlled substances prescriptions or location (room number);
(c) Drug name and strength;
(d) Directions for use;
(e) Date;
(f) Authorized prescriber's name;
(g) Prescriber's address and DEA number, if
applicable;
(h) Refill or end date
instructions, if applicable; and
(i) Dispensing quantity, if
applicable.
(2) A
pharmacist dispensing compounded preparations for veterinary use shall follow
the order requirements of
201 KAR 2:311.
(3) Each compounded preparation dispensed to
patients shall be labeled with the following information:
(a) Name, address, and telephone number of
the licensed pharmacy, if preparation will leave the premises;
(b) Date;
(c) Identifying number;
(d) Patient's full name;
(e) Name of each drug, strength, and
amount;
(f) Directions for use,
including infusion rate;
(g)
Required controlled substances transfer warning, if applicable;
(h) Beyond use date;
(i) Identity of dispensing
pharmacist;
(j) Storage
requirements, if applicable; and
(k) Auxiliary labels, if
applicable.
(4)
Verification of a compounded preparation shall be completed by a pharmacist
after the preparation is compounded and prior to dispensing to the patient.
Documentation of the verification shall include notation of each pharmacist who
performs verification.
Section
6. Recordkeeping.
(1) The PIC
shall maintain access to and provide records and reports to the board or its
agents upon request. Records shall be maintained and readily available for no
less than five (5) years.
(2)
Records. Records shall include the following:
(a) Prescriptions, medical orders, or
requests for compounded preparations;
(b) Purchase records;
(c) Verification records; and
(d) Other records and reports as required by
USP 795, 797, 800, and 825.
Section 7. Violations. Violation of any
provision of this administrative regulation shall constitute unethical or
unprofessional conduct in accordance with
KRS
315.121.
Section 8. Waivers.
(1) All written waiver requests submitted by
a pharmacy shall be considered by the board at its next regularly scheduled
meeting.
(2) The board, upon a
showing of good cause and in balancing the best interest of the public health,
safety and welfare, may waive the requirement of any specified portion of USP
795, 797, 800 or 825 or any provision of this administrative regulation. Any
waiver issued shall identify with specificity the pharmacy to which is applies
and the provisions of law for which the waiver is applied.
Section 9. Enforcement Discretion.
(1) Effective January 1, 2026, the board
shall enforce the 2022 revisions to USP Chapters USP 795, 797, and 800. Until
January 1, 2026, the board shall enforce the 2014 revision of USP 795 and the
2008 revision of USP 797, and the board shall not enforce USP 800. Until
January 1, 2026, at the request of a permit holder, the board may inspect
pursuant to the 2022 revision of the USP Chapters 795, 797, and 800.
(2) The board shall not enforce the USP 795
standard that the addition of flavoring to a commercially available drug is
compounding, if the additive:
(a) Is
non-expired, inert, nonallergenic, and produces no effect other than the
instillation or modification of flavor; and
(b) Is not greater than five (5) percent of
the drug product's total volume.
Section 10. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) "USP 795, Revision Bulletin,
Official", November 1, 2022;
(b)
"USP 795, Revision Bulletin, Official", January 1, 2014;
(c) "USP 797, Revision Bulletin, Official",
November 1, 2022;
(d) "USP 797,
Revision Bulletin Official", June 1, 2008;
(e) "USP 825, Revision Bulletin, Official,
Official", December 1, 2020; and
(f) "USP 800, Revision Bulletin", December 1,
2020.
(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, State Office
Building Annex, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m.
through 4:30 p.m. This material is also available on the board's Web site at
https://pharmacy.ky.gov/statutesandregulations/Pages/default.aspx.
STATUTORY AUTHORITY:
KRS
315.020(1),
315.035(6),
315.0351,
315.191(1)(a),
(g)
