Louisiana Administrative Code
Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS
Part LIII - Pharmacists
Chapter 25 - Prescriptions, Drugs, and Devices
Subchapter C - Compounding of Drugs
Section LIII-2535 - General Standards
Universal Citation: LA Admin Code LIII-2535
Current through Register Vol. 50, No. 9, September 20, 2024
A. Compounding Practices. Compounded medications may be prepared using prescription medications, over-the-counter medications, chemicals, compounds, or other components.
1. A pharmacy shall have
written procedures as necessary for the compounding of drug preparations to
assure that the finished preparations have the identity, strength, quality, and
purity they are represented to possess.
2. All compounding shall be accomplished
utilizing accepted pharmacy techniques, practices, and equipment, and in
compliance with the Federal Food, Drug and Cosmetic Act of 1938 (FDCA) as
subsequently amended, the current edition of Title 21 of the Code of Federal
Regulations (CFR), and all relevant chapters of the United States
Pharmacopeia-National Formulary.
a. The
compounding of sterile preparations pursuant to the receipt of a
patient-specific prescription shall comply with the provisions of section 503A
of the FDCA and USP chapter 797.
b.
The compounding of non-sterile preparations pursuant to the receipt of a
patient-specific prescription shall comply with the provisions of section 503A
of the FDCA and USP chapter 795.
c.
The compounding of preparations for veterinary use shall comply with the
provisions of section 530 of Title 21 of the CFR.
d. The compounding of positron emission
tomography (PET) drugs shall comply with the provisions of section 212 of title
21 of the CFR.
3.
Products or duplicates of products removed from the market for the purposes of
safety shall not be used to compound prescriptions for human use.
B. Board Notification. An applicant or pharmacy permit holder who wishes to engage in the compounding of sterile preparations shall notify the board and shall receive approval from the board prior to beginning that practice.
C. Training and Education. All individuals compounding sterile preparations shall:
1.
obtain practical and/or academic training in the compounding and dispensing of
sterile preparations;
2. complete a
minimum of one hour of Accreditation Council for Pharmacy Education (ACPE)
accredited or board-approved continuing education, on an annual basis, related
to sterile drug preparation, dispensing, and utilization;
3. use proper aseptic technique in
compounding of all sterile preparations, as defined by the pharmacy practice
sites policy and procedure manual;
4. qualify through an appropriate combination
of specific training and experience to operate or manipulate any item of
equipment, apparatus, or device to which such persons will be assigned to use
to make and dispense sterile preparations; and
5. maintain in the pharmacy practice site a
written record of initial and subsequent training and competency evaluations.
The record shall contain the following minimum information:
a. name of the individual receiving the
training/evaluation;
b. date of the
training/evaluation;
c. general
description of the topics covered;
d. signature of the individual receiving the
training/evaluation; and
e. name
and signature of the individual providing the training/evaluation.
D. Anticipated Use Preparations. The pharmacist shall label any excess compounded preparation so as to reference it to the formula used and the assigned lot number and estimated beyond use date based on the pharmacists professional judgment and/or other appropriate testing or published data.
E. Veterinarian-Administered Compounds, also referred to as Pharmacy-Generated Drugs
1.
Upon receipt of a valid non-patient-specific medical order from a licensed
veterinarian, the pharmacy may compound a preparation intended for
administration to an animal patient by the veterinarian.
2. These preparations may not be distributed
to any other third party by the pharmacy, nor may these preparations be further
re-sold or distributed by the veterinarian ordering the preparation from the
pharmacy.
3. This authorization is
primarily intended to facilitate the preparation of medications needed for
emergency use in a veterinary office practice. Given the limited application of
this authorization, which allows these products to be prepared using less
rigorous standards applicable to compounding as opposed to the more rigorous
standards applicable to manufacturing processes, the compounding pharmacy
preparing these products shall be limited in the amount of such products they
can prepare.
a. No Louisiana-licensed
pharmacy may distribute any amount of practitioner-administered compounds in
excess of 5 percent of the total amount of drug products dispensed and/or
distributed from their pharmacy.
b.
The 5 percent limitation shall be calculated on a monthly basis and shall
reference the number of dosage units.
c. For those Louisiana-licensed pharmacies
located outside Louisiana, the total amount distributed and/or dispensed shall
reference the pharmacys total business within the state of Louisiana.
4. The provisions of this
Subsection E notwithstanding, pharmacists intending to engage in the
compounding of veterinary preparations pursuant to non-patient-specific medical
orders from veterinarians should be aware that federal law or rule may not
permit such activity by a licensed pharmacy, and further, such pharmacists
should be aware that the boards rules cannot legitimize an activity that is not
permitted under federal law or rule, and further, such pharmacists should be
aware that while this activity is permitted by the board, pharmacists engaging
in this activity remain subject to the full force and effect of federal law
enforcement.
F. Compounding Copies of Commercial Drug Products.
1. Copies of commercial drug products contain
the same active pharmaceutical ingredient(s) in the same, similar, or easily
substitutable dosage strength which can be used by the same route of
administration. Changes in strength of less than ten percent from the
commercial drug product shall not be considered significant enough to warrant
the preparation of a copy of a commercial drug product. In the event a
prescriber determines a change in the formulation of a commercial drug product
is necessary to produce a significant clinical difference for the patient and
that determination is documented on the prescription, the pharmacy may prepare
a variation of the commercial drug product, provided:
a. the prescriber's determination shall
identify both the relevant change requested and the clinically significant
difference the change will produce for the patient; and
b. the pharmacy does not prepare copies of
commercial drug products regularly or in inordinate amounts.
2. A pharmacy may prepare a copy
of a commercial drug product when that product has been discontinued and is no
longer marketed, or the product appears on the drug shortage list maintained by
the federal Food and Drug Administration, or the product is temporarily
unavailable as demonstrated by invoice or other communication from the
distributor or manufacturer.
G. Labeling of Compounded Preparations
1. For patient-specific compounded
preparations, the labeling requirements of
R.S.
37:1225, or its successor, as well as
§2527 of this Chapter, or its successor
shall apply.
2. For veterinarian
administered compounds, the label shall contain, at a minimum, the following
data elements:
a. pharmacys name, address,
and telephone number;
b.
veterinarians name;
c. name of
preparation;
d. strength and
concentration;
e. lot
number;
f. beyond use
date;
g. special storage
requirements, if applicable;
h.
identification number assigned by the pharmacy; and
i. name or initials of pharmacist responsible
for final check of the preparation.
AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.
Disclaimer: These regulations may not be the most recent version. Louisiana 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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