Podcast
Questions and Answers
What is one of the reasons to compound medication?
What is one of the reasons to compound medication?
Which of the following is NOT a valid reason to compound a medication?
Which of the following is NOT a valid reason to compound a medication?
Who is the primary regulator of non-sterile compounding?
Who is the primary regulator of non-sterile compounding?
What standard must non-sterile compounding follow?
What standard must non-sterile compounding follow?
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When can a compounded preparation be made that is essentially a copy of an approved drug?
When can a compounded preparation be made that is essentially a copy of an approved drug?
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What is the primary purpose of the FDA's Drug Quality and Security Act (DQSA)?
What is the primary purpose of the FDA's Drug Quality and Security Act (DQSA)?
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What is the primary function of a wetting agent in a non-sterile compounded formulation?
What is the primary function of a wetting agent in a non-sterile compounded formulation?
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What is the main difference between o/w and w/o emulsions in compounding ointments and creams?
What is the main difference between o/w and w/o emulsions in compounding ointments and creams?
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What is the primary characteristic of an ointment in compounding?
What is the primary characteristic of an ointment in compounding?
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What is the minimum frequency for refresher training in compounding, as specified by USP Standards?
What is the minimum frequency for refresher training in compounding, as specified by USP Standards?
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Study Notes
Compounding Medications
- Compounding allows for tailored medications to meet specific patient needs, such as those with allergies to certain ingredients or requiring specific dosages.
- A valid reason to compound medication would be to create a medication with specific dosage forms not commercially available, while a non-valid reason might be to create a cheaper alternative to an existing drug.
Regulation and Standards
- The primary regulator of non-sterile compounding is the state pharmacy boards, often in conjunction with federal regulations.
- Non-sterile compounding must follow standards set by the United States Pharmacopeia (USP), particularly USP <795> for non-sterile preparations.
Production of Compounded Medications
- A compounded preparation can essentially copy an approved drug only in cases where there is a need based on patient-specific factors, and no commercially available alternative is suitable.
- The FDA's Drug Quality and Security Act (DQSA) aims to enhance the safety and quality of compounded drugs by establishing clearer standards and regulatory oversight.
Formulation and Emulsion Types
- Wetting agents are used in non-sterile compounded formulations to facilitate the dispersion of solid particles in liquids, improving the uniformity and stability of the preparation.
- The main difference between o/w (oil-in-water) and w/o (water-in-oil) emulsions affects their application; o/w is typically lighter and easier to spread, whereas w/o offers prolonged hydration but can feel greasier.
Ointments and Training
- The primary characteristic of an ointment is its semisolid nature that allows for barrier protection, occlusion, and local drug delivery.
- USP Standards specify that refresher training in compounding should occur at least every three years to ensure proper techniques and safety are maintained.
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Description
Learn the reasons to compound or not compound medications, including removing allergens, changing dosage forms, and unavailable combinations. Understand when compounding is not necessary, such as when medication is commercially available.
