Podcast
Questions and Answers
Which scenario exemplifies a situation where pharmaceutical compounding is most justified over using commercially available products?
Which scenario exemplifies a situation where pharmaceutical compounding is most justified over using commercially available products?
- A pharmacy aims to increase its revenue by offering a wider selection of readily available over-the-counter medications.
- A physician prefers prescribing medications with standard formulations to ensure consistent therapeutic effects across all patients.
- A hospital requires a large batch of a common antibiotic in a standard dosage for its general patient population to reduce costs.
- A patient needs a specific dose of medication that is not manufactured by pharmaceutical companies and requires a unique drug formulation. (correct)
In the context of pharmaceutical compounding, what is the primary role of organizations like the U.S. Pharmacopeia–National Formulary (USP-NF)?
In the context of pharmaceutical compounding, what is the primary role of organizations like the U.S. Pharmacopeia–National Formulary (USP-NF)?
- Establishing and publishing guidelines and standards for pharmaceutical compounding to ensure quality and prevent patient harm. (correct)
- Providing marketing and advertising support for pharmaceutical companies to increase drug sales.
- Lobbying for deregulation of drug manufacturing processes to reduce the cost of medications.
- Promoting the exclusive use of commercially manufactured drugs to avoid the risks associated with compounding.
A compounding pharmacist discovers that the pharmacy's standard operating procedures are not consistently followed, leading to variations in the strength of compounded medications. According to Good Compounding Practices (GCP), what is the most appropriate immediate action?
A compounding pharmacist discovers that the pharmacy's standard operating procedures are not consistently followed, leading to variations in the strength of compounded medications. According to Good Compounding Practices (GCP), what is the most appropriate immediate action?
- Implement a retraining program for all pharmacy personnel involved in compounding, emphasizing adherence to written procedures. (correct)
- Increase the frequency of internal audits while maintaining current production levels to catch errors before they reach patients.
- Report the issue to the pharmacy's insurance provider to mitigate potential liability.
- Continue dispensing the medications but increase monitoring of patient outcomes to detect any adverse effects.
A pharmacist is preparing a topical cream and fails to adequately clean the equipment, leading to microbial contamination of the final product. According to the information, which of the following potential consequences is of greatest concern?
A pharmacist is preparing a topical cream and fails to adequately clean the equipment, leading to microbial contamination of the final product. According to the information, which of the following potential consequences is of greatest concern?
How do pharmaceutical manufacturing and extemporaneous compounding differ in their approach to quality control and standardization?
How do pharmaceutical manufacturing and extemporaneous compounding differ in their approach to quality control and standardization?
How does the establishment of an expiration date by a manufacturer differ from the determination of a beyond-use date by a pharmacy?
How does the establishment of an expiration date by a manufacturer differ from the determination of a beyond-use date by a pharmacy?
A pharmacist is preparing a non-sterile compounded oral solution. No specific stability data is available for the active pharmaceutical ingredient (API). According to USP guidelines, what is the maximum beyond-use date (BUD) that should be assigned to this preparation, assuming appropriate storage at controlled cold temperatures?
A pharmacist is preparing a non-sterile compounded oral solution. No specific stability data is available for the active pharmaceutical ingredient (API). According to USP guidelines, what is the maximum beyond-use date (BUD) that should be assigned to this preparation, assuming appropriate storage at controlled cold temperatures?
Which factor is LEAST important when determining the beyond-use date (BUD) for a compounded topical cream?
Which factor is LEAST important when determining the beyond-use date (BUD) for a compounded topical cream?
A pharmacy technician is asked to cover a large label obscuring most of the original manufacturer's label. Which aspect of the original label is MOST critical to maintain visibility?
A pharmacy technician is asked to cover a large label obscuring most of the original manufacturer's label. Which aspect of the original label is MOST critical to maintain visibility?
A compounding pharmacist is preparing both a non-aqueous formulation and a water-containing oral formulation. Both lack specific stability data. What is the MOST significant difference in how their beyond-use dates (BUDs) should be determined?
A compounding pharmacist is preparing both a non-aqueous formulation and a water-containing oral formulation. Both lack specific stability data. What is the MOST significant difference in how their beyond-use dates (BUDs) should be determined?
Flashcards
Expiration Date
Expiration Date
The date a manufacturer guarantees a medication's strength and safety.
Beyond-Use Date (BUD)
Beyond-Use Date (BUD)
The date a compounded prescription should no longer be used, determined by the pharmacy.
BUD for Non-Aqueous Formulations
BUD for Non-Aqueous Formulations
For non-aqueous formulations, the BUD is no later than the earliest expiration date of any API or 6 months, whichever is earlier.
BUD for Water-Containing Oral Formulations
BUD for Water-Containing Oral Formulations
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BUD for Water-Containing Topical Formulations
BUD for Water-Containing Topical Formulations
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Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
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Extemporaneous Compounding
Extemporaneous Compounding
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Reasons for Compounding
Reasons for Compounding
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USP-NF in Compounding
USP-NF in Compounding
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Good Compounding Practices (GCP)
Good Compounding Practices (GCP)
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Study Notes
- Pharmaceutical manufacturing involves large-scale drug production for distribution and sale.
- Compounding is the preparation of prescriptions for individual patients, a traditional pharmacy practice.
Reasons for Increased Patient-Specific Medications
- Many patients need drug dosages or strengths that are not commercially available.
- Some patients require dosage forms like suppositories, oral liquids, or topical applications not commercially available.
- Patients may have allergies to excipients found in commercially available products.
- Pediatric medications often need to be prepared as flavored liquids to improve compliance.
- Some medications are unstable and need frequent preparation and dispensing.
- Home health and hospice care requires new approaches to pain management with higher drug concentrations and combinations.
Quality Standards for Compounded Products
- Since 1990, efforts have been made to ensure the quality of compounded drugs, with standards-setting agencies developing guidelines.
- Chapters and monographs related to pharmacy compounding are published in the U.S. Pharmacopeia–National Formulary (USP-NF).
- USP-NF provides tested, uniform formulations with valid beyond-use dating.
- USP-NF establishes conditions and practices to prevent harm from microbial contamination, bacterial endotoxins, variability in strength and composition, chemical and physical contaminants, and inappropriate ingredients.
Good Compounding Practices (GCP)
- The National Association of Boards of Pharmacy developed "Good Compounding Practices (GCP) applicable to Pharmacies" for state-licensed pharmacies.
- GCP addresses general provisions and definitions.
- GCP addresses organization and personnel.
- GCP covers drug compounding facilities.
- GCP includes information about equipment.
- GCP includes information about control of components, drug product containers, and closures.
- GCP includes written procedures to ensure finished products have proper identity, strength, quality, and purity, as labeled.
- GCP covers labeling, control of excess products, and records and reports.
Expiration Date vs. Beyond-Use Date
- Expiration Date is the date a manufacturer guarantees a medication's strength and safety.
- It is determined by the US Food and Drug Administration.
- Based on drug-specific testing under certain storage conditions like the type of containers, lighting, and temperature.
- Usually given in "years" for commercial products.
- Beyond-Use Date is the date a compounded prescription should no longer be used.
- It is determined by the pharmacy when filling a prescription.
- It is based on the drug type, how fast it degrades, dosage, container type, storage conditions, prescription length, and contamination likelihood.
- Generally given in days or months.
Maximum Beyond-Use Dates (BUDs) for Non-Sterile Compounded Drug Preparations
- Recommended maximum BUDs are for non-sterile compounded drug preparations without specific stability information.
- Non-aqueous formulations have a BUD of no later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier.
- Water-containing oral formulations have a BUD of no later than 14 days when stored at controlled cold temperatures.
- Water-containing topical/dermal and mucosal liquid and semi-solid formulations have a beyond-use date of no later than 30 days.
Proper Packaging, Labeling and Storage
- Proper packaging, labeling, and storage are crucial for maintaining product stability and efficacious use.
- Containers are important.
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Description
Pharmaceutical manufacturing involves large-scale drug production, while compounding is the preparation of prescriptions for individual patients. Patient-specific medications are needed due to unavailable dosages, allergies, or the need for specialized dosage forms. Quality standards ensure the safety and efficacy of compounded drugs.
