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drug product for human use that the FDA has identified as presenting demonstrable difficulties in compounding or has withdrawn or removed from the market for safety or efficacy reasons is prohibited.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

Idaho Admin. Code r. 24.36.01.700