Ariz. Admin. Code § R4-23-410 - Current Good Compounding Practices
A. This Section establishes the current good
compounding practices to be used by a pharmacist licensed by the Board, in a
pharmacy permitted by the Board, and in compliance with applicable federal and
state law governing the practice of pharmacy.
B. A pharmacy permittee shall ensure
compliance with the provisions in this subsection.
1. All substances for compounding that are
received, stored, or used by the pharmacy permittee :
a. Meet official compendium
requirements;
b. Are of high
quality, such as Chemically Pure (CP), Analytical Reagent (AR), certified
American Chemical Society (ACS), or Food Chemical Codex (FCC) grade;
or
c. Are obtained from a source
that, in the professional judgment of the pharmacist, is acceptable and
reliable.
2. Before
compounding a pharmaceutical product in excess of the quantity dispensed in
anticipation of receiving valid prescriptions for the pharmaceutical product, a
pharmacist, employed by the pharmacy permittee , shall establish a history of
compounding valid prescriptions for the pharmaceutical product.
3. Neither the pharmacy permittee nor a
pharmacist employed by the pharmacy permittee provides a compounded
pharmaceutical product to a pharmacy, medical practitioner, or other person for
dispensing or distributing except that a compounded pharmaceutical product may
be provided to a medical practitioner to administer to a patient of the medical
practitioner if each container is accompanied by the written list required in
subsection (I)(5) and has a label that includes the following:
a. The pharmacy's name, address, and
telephone number;
b. The
pharmaceutical product's name and the information required in subsection
(I)(4);
c. A lot or control
number ;
d. A beyond-use-date based
upon the pharmacist's professional judgment, but not more than the maximum
guidelines recommended in the Pharmacy Compounding Practices chapter of the
official compendium unless there is published or unpublished stability test
data that shows a longer period is appropriate;
e. The statement "Not For Dispensing;"
and
f. The statement "For Office or
Hospital Administration Only."
4. A pharmacy or pharmacist may advertise or
otherwise promote the fact that the pharmacy or pharmacist provides
prescription compounding services.
C. A pharmacy permittee shall ensure
compliance with the organization, training, and personnel issues in this
subsection.
1. Before dispensing a compounded
pharmaceutical product, a pharmacist:
a.
Inspects and approves or rejects, or assumes responsibility for inspecting and
approving or rejecting, components, pharmaceutical product containers and
closures, in-process materials, and labeling;
b. Prepares or assumes responsibility for
preparing all compounding records;
c. Reviews all compounding records to ensure
that no errors occur in the compounding process;
d. Ensures the proper use, cleanliness, and
maintenance of all compounding equipment; and
e. Documents by hand-written initials or
signature in the compounding record the completion of the requirements of
subsections (C)(1)(a), (b), (c), and (d).
2. A pharmacist engaged in compounding:
a. Complies with the current good compounding
practices and applicable state pharmacy laws;
b. Maintains compounding proficiency through
current awareness, training, and continuing education ; and
c. Ensures that personnel engaged in
compounding wear:
i. Clean clothing
appropriate to the work performed; and
ii. Protective apparel, such as coats,
aprons, gowns, gloves or masks to protect the personnel from chemical exposure
and prevent pharmaceutical product contamination.
D. A pharmacy permittee
shall ensure the security, safety, and quality of a compounded pharmaceutical
product by conforming with the following standards:
1. Implement procedures to exclude from
direct contact with components, pharmaceutical product containers and closures,
in-process materials, labeling, and pharmaceutical products, any person with an
apparent illness or open lesion that may adversely affect the safety or quality
of a compounded pharmaceutical product, until the illness or lesion, as
determined by competent medical personnel, does not jeopardize the safety or
quality of a compounded pharmaceutical product; and
2. Require all personnel to inform a
pharmacist of any health condition that may adversely affect a compounded
pharmaceutical product.
E. A pharmacy permittee shall provide
compounding facilities that conform with the standards in this subsection.
1. In addition to the minimum area
requirements of
R4-23-609,
R4-23-655, or
R4-23-673,
the compounding area:
a. Complies with the
requirements in R4-23-611; and
b.
Has sufficient space to permit efficient pharmacy practice, free movement of
personnel, and visual surveillance by a pharmacist.
2. If sterile pharmaceutical product or
radiopharmaceutical product compounding is performed, the compounding area
complies with the requirements of
R4-23-670,
R4-23-681,
and R4-23-682.
3. A clean, dry, and
temperature-controlled area and, if required, a refrigerated area, in which to
store properly labeled containers of bulk drugs, chemicals, and materials used
in compounding, that complies with state statutes and rules.
F. To protect pharmaceutical
product safety, identity, strength, quality, and purity, a pharmacy permittee
shall ensure that equipment and utensils used in pharmaceutical product
compounding are:
1. Of appropriate design,
adequate size, and suitably located for proper operation, cleaning, and
maintenance;
2. Made of material
that is not reactive, additive, or absorptive when exposed to components,
in-process materials, or pharmaceutical products;
3. Cleaned and protected from contamination
before use;
4. Inspected and
determined suitable for use before initiation of compounding operations;
and
5. Routinely inspected,
calibrated, or checked to make proper performance certain.
G. A pharmacy permittee shall ensure that the
pharmacist-in-charge establishes, implements, and complies with procedures to
prevent cross-contamination when pharmaceutical products that require special
precautions to prevent cross-contamination, such as penicillin, are used in a
compounding procedure. The procedures shall include either the dedication of
equipment or the meticulous cleaning of contaminated equipment before its use
in compounding other pharmaceutical products.
H. A pharmacy permittee shall ensure that the
pharmacist-in-charge establishes, implements, and complies with control
procedures for components and pharmaceutical product containers and closures,
either written or electronically stored with printable documentation, that
conform with the standards in this subsection.
1. Components and pharmaceutical product
containers and closures are:
a. Stored off the
floor,
b. Handled and stored to
prevent contamination, and
c.
Rotated so the oldest approved stock is used first.
2. Container closure systems comply with
official compendium standards.
3.
Pharmaceutical product containers and closures are clean and made of material
that is not reactive, additive, or absorptive.
I. A pharmacy permittee shall ensure that the
pharmacist-in-charge establishes, implements, and complies with pharmaceutical
product compounding controls that conform with the standards in this
subsection.
1. Pharmaceutical product
compounding procedures are available in either written form or electronically
stored with printable documentation:
a. To
ensure that a finished pharmaceutical product has the identity, strength,
quality, and purity it is purported or represented to possess, the procedures
include, for each pharmaceutical product compounded, a description of:
i. The components, their manufacturer, lot
number , expiration date, and amounts, the order of component addition, if
applicable, and the compounding process;
ii. The equipment and utensils used;
and
iii. The pharmaceutical product
container and closure system proper for the sterility and stability of the
pharmaceutical product as it is intended to be used.
b. To test the pharmaceutical product being
compounded, the procedures monitor the output and validate the performance of
compounding processes that may cause variability in the final pharmaceutical
product, including assessing:
i. Dosage form
weight variation;
ii. Adequacy of
mixing to ensure uniformity and homogeneity; and
iii. Clarity, completeness, and pH of
solutions, if applicable.
2. Components for pharmaceutical product
compounding are accurately weighed, measured, or subdivided. To ensure that
each weight, measure, or subdivision is correct as stated in the compounding
procedures, a pharmacist:
a. Checks and
rechecks, or assumes responsibility for checking and re-checking, the
operations at each stage of the compounding process; and
b. Documents by hand-written initials or
signature the completion and accuracy of the compounding process.
3. Compounding equipment and
utensils are properly cleaned and maintained.
4. In addition to the labeling requirements
of A.R.S. §
32-1968(D), the label contains:
a. A statement, symbol,
designation, or abbreviation that the pharmaceutical product is a compounded
pharmaceutical product, and
b. A
beyond-use-date as specified in subsection (B)(3)(d).
5. A written list of the compounded
pharmaceutical product's active ingredients is given to the patient at the time
of dispensing.
6. When a component
is removed from its original container and transferred to another container,
the new container label contains, in full text or an abbreviated code system,
the following:
a. The component
name,
b. The manufacturer's or
supplier's name,
c. The lot or
control number ,
d. The weight or
measure,
e. The beyond-use-date as
specified in subsection (B)(3)(d), and
f. The transfer date.
J. A pharmacy permittee shall
ensure that the pharmacist-in-charge stores any quantity of compounded
pharmaceutical product produced in excess of the quantity dispensed in
accordance with subsection (B):
1. In an
appropriate container with a label that contains:
a. A complete list of components or the
pharmaceutical product's name;
b.
The preparation date;
c. The
assigned lot or control number ; and
d. A beyond-use-date as specified in
subsection (B)(3)(d); and
2. Under conditions, dictated by the
pharmaceutical product's composition and stability characteristics, that ensure
its strength, quality, and purity.
K. A pharmacy permittee shall ensure that the
pharmacist-in-charge establishes, implements, and complies with recordkeeping
procedures that comply with this subsection:
1. Pharmaceutical product compounding
procedures and other records required by this Section are maintained by the
pharmacy for not less than seven years, and
2. Pharmaceutical product compounding
procedures and other records required by this Section are readily available for
inspection by the Board or its designee.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.