NMBOP: 16.19.30 COMPOUNDING OF NON-STERILE PHARMACEUTICALS Flashcards
“Active pharmaceutical ingredient (API)”
“Active pharmaceutical ingredient (API)” any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body.
“Beyond-use date (BUD)”
the date after which a compounded preparation should not be used and is determined from the date the preparation was compounded.
“Component”
“Component” any ingredient intended for use in the compounding of a drug product, including those that may not appear in such product labeling.
Q: What is considered “compounding” and what are the exceptions?
A: “Compounding” includes the preparation, mixing, assembling, packaging, or labeling of a drug or device based on a practitioner’s prescription order, or preparing limited quantities of prescription orders within an established practitioner-patient-pharmacist relationship. Reconstitution of commercial products is not considered compounding. Additionally, adding a flavoring agent to a conventionally manufactured product is not considered compounding if the flavoring agent is inert, nonallergenic, does not alter the medication’s concentration beyond USP’s accepted level of variance, and is documented in the prescription record.
Q: What are the responsibilities of the pharmacist-in-charge regarding non-sterile compounding?
A: The pharmacist-in-charge is responsible for:
1. Ensuring all personnel involved in non-sterile compounding have the necessary education, training, and proficiency.
2. Ensuring that all personnel obtain continuing education appropriate for their compounding duties.
3. Ensuring that compounding equipment is properly maintained.
4. Maintaining an appropriate environment for non-sterile compounding.
5. Developing and following effective quality control procedures.
6. Providing access to current reference sources for the type of compounding conducted.
Q: What are the special requirements for pharmacists engaged in non-sterile compounding?
A: Pharmacists engaged in non-sterile compounding must:
1. Possess the necessary education, training, and proficiency for compounding duties and obtain continuing education for their compounding work.
2. Inspect and approve all components, drug product containers, closures, labeling, and other materials involved in compounding.
3. Review all compounding records for accuracy and conduct in-process and final checks to ensure no errors have occurred.
4. Be responsible for the proper maintenance, cleanliness, and use of all compounding equipment.
Q: What are the requirements for pharmacy technicians involved in non-sterile compounding?
A: Pharmacy technicians engaged in non-sterile compounding must:
1. Possess the necessary education, training, and proficiency for their compounding duties.
2. Obtain continuing education relevant to their compounding tasks.
3. Perform compounding duties under the direct supervision of a pharmacist.
Q: What is required for the training of personnel involved in non-sterile compounding?
A: All personnel involved in non-sterile compounding must:
1. Be trained in compounding procedures.
2. Participate in continuing relevant training programs.
Q: What are the general requirements for non-sterile drug compounding?
A: Non-sterile drug products may be compounded in licensed pharmacies under these conditions:
1. As a result of a practitioner’s prescription order based on the practitioner-patient-pharmacist relationship in professional practice.
2. Preparing limited quantities in anticipation of future prescription drug orders based on past valid prescriptions, with the beyond-use date based on USP Chapter <795> and labeling requirements including:
- Name and strength of the compounded medication or list of active ingredients.
- Facility’s lot number.
- Beyond-use date.
- Quantity or amount in the container.
3. Compounding commercially available products for individual patients only if:
- The product is not reasonably available from distribution channels in a timely manner.
- The prescribing practitioner requests compounding.
- The compounded product differs significantly from the commercial product, such as removal of a dye for medical reasons.
4. Compounding veterinary preparations:
- Based on a veterinarian’s order or prescription.
- Handled and filled like human prescriptions.
- In accordance with the Animal Medicinal Drug Use Clarification Act of 1994 or successor Act.
- May be compounded for office use under certain conditions, with restrictions on distribution and prohibitions on wholesaling and providing samples.
Q: What are the environmental standards for pharmacies engaging in non-sterile compounding?
A: Pharmacies must:
1. Have a designated and adequate area for safe and orderly compounding, or prepare an area prior to compounding for occasional activities.
2. Ensure only authorized personnel are in the immediate compounding area.
3. Provide a sink with hot and cold running water, separate from restroom facilities, and maintain it in a sanitary condition.
4. Use appropriate measures to prevent cross-contamination, including dedicating equipment or cleaning thoroughly.
Q: What equipment and supplies are required for non-sterile compounding?
A: Pharmacies must:
1. Have a Class A prescription balance or analytical balance and weights, properly maintained and subject to inspection.
2. Have equipment and utensils necessary for compounding that are:
- Appropriately designed and operated within limits.
- Non-reactive, non-additive, and non-absorptive.
- Cleaned and sanitized appropriately.
- Routinely inspected, calibrated, or checked for proper performance.
Q: What labeling requirements apply to compounded drug products?
A: Labels on compounded drug products must include:
1. Generic name(s) or designated name and strength of the preparation.
2. Quantity dispensed.
3. Date the product was compounded.
4. Lot or batch number.
5. Beyond-use date (BUD) with specific guidelines:
- Non-aqueous formulations: BUD is not later than the earliest expiration date of any API or six months.
- Non-aqueous oral liquids: BUD is not later than the earliest expiration date of any API or 90 days.
- Non-preserved aqueous formulations: BUD is not later than the earliest expiration date of any API or 14 days.
- Preserved aqueous formulations: BUD is not later than the earliest expiration date of any API or 35 days.
- BUDs can be exceeded with valid scientific stability information but must not exceed the expiration date of any component.
Q: What are the standards for drugs, components, and materials used in non-sterile compounding?
A: Standards include:
1. Using USP/NF grade substances manufactured in FDA registered facilities when possible.
2. Establishing and documenting stability and purity if USP/NF grade substances are not available.
3. Not compounding drug products withdrawn or removed from the market for safety reasons.
Q: What is required for the compounding process in pharmacies?
A: Pharmacies must:
1. Develop and follow written SOPs based on USP Chapter <795> to ensure accountability, accuracy, quality, safety, and uniformity in the compounding process.
Q: What are the quality control requirements for compounded drug products?
A: Quality control must include:
1. Monitoring for uniformity and consistency, including capsule weight variations, mixing adequacy, and solution clarity or pH.
2. Verifying compounding procedures according to written procedures, including checking calculations, weighing, measuring, mixing, and techniques.
3. Ensuring compounded preparations contain between 90% and 110% of the labeled quantity of active ingredient per unit volume or weight.
