Idaho Admin. Code r. 24.36.01.700 - COMPOUNDING DRUG PREPARATIONS
Any compounding that is not permitted herein is considered manufacturing. (3-28-23)
01.
Application. This rule applies to any person, including any
business entity, authorized to engage in the practice of non-sterile
compounding, sterile compounding, and sterile prepackaging of drug products in
or into Idaho, except these rules do not apply to: (3-28-23)
a. Compound positron emission tomography
drugs; (3-28-23)
b.
Radiopharmaceutics; (3-28-23)
c.
The reconstitution of a non-sterile drug or a sterile drug for immediate
administration; (3-28-23)
d. The
addition of a flavoring agent to a drug product; and (3-28-23)
e. Product preparation of a non-sterile,
non-hazardous drug according to the manufacturer's FDA approved labeling.
(3-28-23)
02.
General Compounding Standards. (3-28-23)
a. Active Pharmaceutical Ingredients. All
active pharmaceutical ingredients must be obtained from an FDA registered
manufacturer. FDA registration as a foreign manufacturer satisfies this
requirement. (3-28-23)
b.
Certificate of Analysis (COA). Unless the active pharmaceutical ingredient
complies with the standards of an applicable USP-NF monograph, a COA must be
obtained for all active pharmaceutical ingredients procured for compounding and
retained for a period of not less than three (3) years from the date the
container is emptied, expired, returned, or disposed of. The following minimum
information is necessary on the COA: product name, lot number, expiration date,
and assay. (3-28-23)
c. Equipment.
Equipment and utensils must be of suitable design and composition and cleaned,
sanitized, or sterilized as appropriate prior to use. (3-28-23)
d. Disposal of Compromised Drugs. When the
correct identity, purity, strength, and sterility of ingredients and components
cannot be confirmed (in cases of, for example, unlabeled syringes, opened
ampoules, punctured stoppers of vials and bags, and containers of ingredients
with incomplete labeling) or when the ingredients and components do not possess
the expected appearance, aroma, and texture, they must be removed from stock
and isolated for return, reclamation, or destruction.
(3-28-23)
03.
Prohibited Compounding. Compounding any drug product for human use
that the FDA has identified as presenting demonstrable difficulties in
compounding or has withdrawn or removed from the market for safety or efficacy
reasons is prohibited. (3-28-23)
04.
Limited Compounding.
(3-28-23)
a. Triad Relationship. A pharmacist
may compound a drug product in the usual course of professional practice for an
individual patient pursuant to an established prescriber /patient/pharmacist
relationship and a valid prescription drug order. (3-28-23)
b. Commercially Available Products. A drug
product that is commercially available may only be compounded if not compounded
regularly or in inordinate amounts and if: (3-28-23)
i. It is medically warranted to provide an
alternate ingredient, dosage form, or strength of significance; or
(3-28-23)
ii. The commercial
product is not reasonably available in the market in time to meet the patient's
needs. (3-28-23)
c.
Anticipatory Compounding. Limited quantities of a drug product may be
compounded or sterile prepackaged prior to receiving a valid prescription drug
order based on a history of receiving valid prescription drug orders for the
compounded or sterile prepackaged drug product. (3-28-23)
05.
Drug Compounding Controls.
(3-28-23)
a. Policies and Procedures. In
consideration of the applicable provisions of USP Chapter 795 concerning
pharmacy compounding of non-sterile preparations, USP Chapter 797 concerning
sterile preparations, Chapter 1075 of the USP-NF concerning good compounding
practices, and Chapter 1160 of the USP-NF concerning pharmaceutical
calculations, policies and procedures for the compounding or sterile
prepackaging of drug products must ensure the safety, identity, strength,
quality, and purity of the finished product, and must include any of the
following that are applicable to the scope of compounding practice being
performed: (3-28-23)
i. Appropriate packaging,
handling, transport, and storage requirements; (3-28-23)
ii. Accuracy and precision of calculations,
measurements, and weighing; (3-28-23)
iii. Determining ingredient identity,
quality, and purity; (3-28-23)
iv.
Labeling accuracy and completeness; (3-28-23)
v. Beyond use dating; (3-28-23)
vi. Auditing for deficiencies, including
routine environmental sampling, quality and accuracy testing, and maintaining
inspection and testing records; (3-28-23)
vii. Maintaining environmental quality
control; and (3-28-23)
viii. Safe
limits and ranges for strength of ingredients, pH, bacterial endotoxins, and
particulate matter. (3-28-23)
b. Accuracy. Components including, but not
limited to, bulk drug substances, used in the compounding or sterile
prepackaging of drug products must be accurately weighed, measured, or
subdivided, as appropriate. The amount of each active ingredient contained
within a compounded drug product must not vary from the labeled potency by more
than the drug product's acceptable potency range listed in the USP-NF monograph
for that product. If USP-NF does not publish a range for a particular drug
product, the active ingredients must not contain less than ninety percent (90%)
and not more than one hundred ten percent (110%) of the potency stated on the
label. (3-28-23)
c. Non-Patient
Specific Records. Except for drug products that are being compounded or sterile
prepackaged for direct administration, a production record of drug products
compounded or sterile prepackaged in anticipation of receiving prescription
drug orders or distributed in the absence of a patient specific prescription
drug order ("office use") solely as permitted in these rules, must be prepared
and kept for each drug product prepared, including: (3-28-23)
i. Production date; (3-28-23)
ii. Beyond use date; (3-28-23)
iii. List and quantity of each ingredient;
(3-28-23)
iv. Internal control or
serial number; and (3-28-23)
v.
Initials or unique identifier of all persons involved in the process or the
compounder responsible for the accuracy of these processes.
(3-28-23)
Notes
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