Arkansas Administrative Code
Agency 070 - Board of Pharmacy
Rule 070.00.01-001 - 07-02-0002 - Good Compounding Practices
Universal Citation: AR Admin Rules 070.00.01-001
Current through Register Vol. 49, No. 2, February 2024
A. This regulation describes the requirements of minimum current good compounding practice for the preparation of drug products by pharmacies or other facilities with permits issued by the Arkansas State Board of Pharmacy.
B. Definitions:
The following words or terms, when used in this regulation, shall have the following meaning, unless the context clearly indicates otherwise:
1. Compounding: means the preparation,
mixing, assembling, packaging, and labeling of a drug or device as the result
of a duly authorized practitioner's prescription drug order or initiative based
on the Practitioner/Patient/Pharmacist relationship in the course of
professional practice.
a. Compounding may also
be for the purpose of, or as an incident to, research, teaching, or chemical
analysis.
b. Compounding includes
the preparation of Drugs or Devices in anticipation of prescription drug orders
based on routine, regularly observed prescribing patterns.
c. Reconstitution of commercial products is
not considered compounding for the purposes of this
regulation.
2. Component:
means any ingredient used in the compounding of a drug product, including those
that may not appear in such product.
3. Manufacturing: means the production,
preparation, propagation, conversion, or processing of a drug or device, either
directly or indirectly by extraction from substances of natural origin or
independently by means of chemical or biological synthesis and includes any
packaging or repackaging of the substance(s) or labeling or re-labeling of its
container, and the promotion and marketing of such drugs or devices.
Manufacturing also includes any preparation of a drug or device that is given
or sold for resale by pharmacies, practitioners, or other persons. The
distribution of inordinate amounts of compounded products, without a
practitioner/patient/pharmacist relationship is considered
manufacturing.
4. Pharmacy
Generated Products (PGP: means a medical product that is prepared, packaged,
and labeled in a pharmacy that can be sold by the pharmacy without a
prescription.
C. Pharmacist Responsibilities:
1. All
pharmacists, who engage in drug compounding, shall be proficient in compounding
and shall continually expand their compounding knowledge by participating in
seminars and/or studying appropriate literature.
2. Every pharmacist engaging in drug
compounding must be familiar with all details of Good Compounding Practices and
should be familiar with FDAMA related patient regulation.
3. The pharmacist has the responsibility to:
a. Assure the validity of all
prescriptions;
b. approve or reject
all components, drug product containers, closures, in-process materials, and
labeling;
c. prepare and review all
compounding records and proceduresto assure that no errors have occurred in the
compounding process;
d. assure the
proper maintenance, cleanliness, and use of all equipment used in a
prescription compounding practice;
e. assure only personnel authorized by the
pharmacist in charge shall be in the immediate vicinity of the drug compounding
operation.
D. Drug Compounding Facilities:
1. Pharmacies
engaging in compounding shall have a specifically designated and adequate area
(space) for the orderly compounding of prescriptions, including the placement
or equipment and materials.
2. The
aseptic processing for sterile products shall be in an area separate and
distinct from the area used for the compounding of non-sterile drug
products.
3. The area(s) used for
the compounding of drugs shall be maintained in a good state of
repair.
4. Bulk drugs and other
chemicals or materials used in the compounding of drugs must be stored in
adequately labeled containers in a clean, dry area or, if required, under
proper refrigeration.
5. Adequate
lighting and ventilation shall be provided in all compounding areas.
6. Potable water shall be supplied under
continuous positive pressure in a plumbing system free of defects that could
contribute contamination to any compounded drug product.
7. These area(s) used for compounding shall
be maintained in a clean and sanitary condition.
8. If parenteral products are being
compounded, standards set out in Board Regulation 07-02-0001 must be
met.
E. Compounding Equipment
1. Equipment used in the compounding
of drug products shall be of appropriate design and capacity as well as
suitably located to facilitate operations for its intended use, cleaning, and
maintenance.
2. Compounding
equipment shall be of suitable composition so the surfaces that contact
components shall not be reactive, additive, or absorptive so as to alter the
purity of the product compounded.
3. Equipment and utensils used for
compounding shall be cleaned and sanitized immediately prior to use to prevent
contamination.
4. Equipment and
utensils must be stored in a manner to protect from contamination.
5. Automated, mechanical, electronic, limited
commercial scale manufacturing or testing equipment, and other types of
equipment may be used in the compounding of drug products. If such equipment is
used, it shall be routinely inspected, calibrated (if necessary), or checked to
ensure proper performance.
6.
Immediately prior to the initiation of compounding operations, the equipment
and utensils must be inspected by the pharmacist and determined to be suitable
for use.
7. When drug products with
special precautions (antibiotics, hazardous materials and cytotoxins) are
involved, appropriate measures must be utilized in order to prevent
cross-contamination and proper disposal procedures must be followed. These
measures include either the dedication of equipment for such operations or the
meticulous cleaning of equipment prior to its use for the preparation of other
drugs.
F. Component Selection Requirements:
1. Pharmacists shall
first attempt to use USP-NF drug substances for compounding that have been made
in an FDA inspected facility.
2. If
components are not obtainable from a FDA-inspected facility of if the FDA
and/or the company cannot document FDA inspection, pharmacists compounding
prescriptions shall use their professional judgement in first receiving,
storing, or using drug components that meet official compendia requirements or
another high quality source.
G. Control of Drug Products:
1. Drug product containers and closures shall
be handled and stored in a manner to prevent contamination and to permit
inspection and cleaning of the work area.
2. Containers and closures shall be suitable
material as to not alter the compounded drug as to quality, strength, or
purity.
H. Drug Compounding Controls:
1. There shall be
written procedures for the compounding of drug products to assure that the
finished products have the identity, strength, quality and purity they purport
or are represented to possess.
2.
Procedures shall include a listing of the components, their amounts (in weight
or volume), the order of component mixing, and a description of the compounding
process.
3. All equipment and
utensils and the container/closure system relevant to the sterility and
stability of the intended use of the drug shall be listed.
4. All written procedures shall be followed
in the execution of the compounding procedure.
5. Components shall be accurately weighed,
measured, or subdivided as appropriate. These operations should be checked and
rechecked by the compounding pharmacist at each stage of the process to ensure
that each weight and measure is correct as stated in the written compounding
procedures.
6. Written procedures
shall be established and followed that describe the tests or examination to be
conducted on the product compounded (e.g. degree of weight variation among
capsules) to assure reasonable uniformity and integrity of compounded drug
products.
a. Such control procedures shall be
established to monitor the output and to validate the performance of those
compounding processes that may be responsible for causing variability in the
final drug product.
b. Such control
procedures shall include, but are not limited to, the following (where
appropriate):
i. capsule weight
variation;
ii. adequacy of mixing
to assure uniformity and homogeneity; and
iii. clarity, completeness or pH of
solutions.
7.
Appropriate written procedures designed to prevent microbiological
contamination of compounded drug products purporting to be sterile shall be
established and followed. Such procedures shall follow accepted standards of
practice and/or include validation of any sterilization process.
8. Beyond use dates and storage requirements
(e.g. refrigeration) should be established. The USP-NF guidelines should be
used.
I. Labeling:
1. If a component is transferred from the
original container to another (e.g. a powder is taken from the original
container, weighed, placed in a container) and stored in another container) the
new container shall be identified with the:
a.
component name;
b. lot and
expiration date if available;
c.
strength and concentration; and
d.
weight or measure.
e. Route of
administration
2.
Products prepared in anticipation of a prescription prior to receiving a valid
prescription should not be an inordinate amount.
a. A regularly used amount should be prepared
based on a history of prescriptions filled by the pharmacy.
b. These products shall be labeled or
documentation referenced with the:
i. complete
list of ingredients or preparation name and reference;
ii. federal expiration date-up to one (1)
year;
iii. assigned beyond -use
date:
(a) based on published data,
or;
(b) appropriate testing,
or;
(c) USP-NF standards.
iv. storage under conditions
dictated by its composition and stability (e.g., in a clean, dry place or in
the refrigerator); and
v. batch or
lot number.
3.
Upon the completion of the drug preparation operation, the pharmacist shall
examine the product for correct labeling.
4. The prescription label shall contain the
following:
a. patient name;
b. prescriber's name;
c. name and address of pharmacy;
d. directions for use;
e. date filled;
f. beyond use date and storage (may be
auxiliary labels); and
g. an
appropriate designation that this is a compounded prescription, with reference
to active ingredients.
J. Records and Reports:
1. Any procedures or other records required
to comply with good compounding practices shall be retained for the same period
of time as required for retention of prescription records.
2. All records required to be retained under
good compounding practices, or copies of such records, shall be readily
available for authorized inspection.
3. Computer information and the hard copy of
the prescription should indicate that the prescription is to be
compounded.
4. Adequate records
must be kept of controlled substances (Scheduled drugs) used in
compounding.
K. Pharmacy Generated Product Requirements:
1. A Pharmacy
Generated Product (PGP) may be prepared from legend drugs, not to exceed
recommended strengths and doses.
2.
PGP will be labeled properly and will be sold with the public's health and
welfare in mind.
3. A PGP cannot be
bulk compounded to sell to a second entity for resale. This would require a
manufacturer's permit.
L. Compounding for a Prescriber's Office Use:
1.
Pharmacies may prepare compounded drug products for a duly authorized
prescriber's office use.
2. An
order by the duly authorized prescriber, indicating the formula and quantity
ordered, will be filed in the pharmacy.
3. The product is to be administered in the
office and not dispensed to the patient. The product shall be labeled "For
Office Use Only-Not for Resale".
4.
A record of the compounded drug product may be kept as a prescription record in
the pharmacy computer.
5. A label
may be generated and a number assigned by the pharmacy computer for the
compounded drug product.
6. Patient
specific prescriptions for controlled substances cannot be filled "for office
or medical bag use".
7. A retail
pharmacy is not precluded from making more that five percent (5%) of its annual
sales to licensed practitioners. The pharmacy must, however, obtain a State
Wholesale Legend Drug and/or Controlled Substance Distributor Permit.
M. Compounding Veterinarian Products:
1. Prescriptions for animals may be
compounded based on an order or prescription from a duly authorized
prescriber.
2. These prescriptions
are to be handled and filled the same as the human prescriptions.
3. Caution should be taken as to not violate
federal patent laws by duplicating an available product in inordinate
quantities.
4. Patient specific
prescriptions for controlled substances cannot be filled "for office or medical
bag use".
Disclaimer: These regulations may not be the most recent version. Arkansas 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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