Podcast
Questions and Answers
What is the primary role of a pharmacist in the compounding process?
What is the primary role of a pharmacist in the compounding process?
- Manufacturing large quantities of drugs
- Preparing individualized medications (correct)
- Prescribing medications to patients
- Conducting clinical trials for FDA approval
Which of the following accurately describes the triad of compounding?
Which of the following accurately describes the triad of compounding?
- Physician, pharmacist, payer
- Physician, pharmacist, patient (correct)
- Pharmacist, patient, insurer
- Pharmacist, manufacturer, patient
In which scenario would the addition of flavors to a liquid medication be considered compounding?
In which scenario would the addition of flavors to a liquid medication be considered compounding?
- When it involves reconstituting an antibiotic
- When it alters the original product significantly (correct)
- When the flavor is already approved by the FDA
- When it is added by the manufacturer
What is NOT a characteristic of compounded medications compared to manufactured drugs?
What is NOT a characteristic of compounded medications compared to manufactured drugs?
What distinguishes the shelf-life data for compounded preparations from that of manufactured drugs?
What distinguishes the shelf-life data for compounded preparations from that of manufactured drugs?
Which of the following is a function of compounding that is specifically noted in the content?
Which of the following is a function of compounding that is specifically noted in the content?
Why is FDA approval not needed for compounded medications?
Why is FDA approval not needed for compounded medications?
What is the relationship termed when a physician prescribes and compounds a medication for a patient?
What is the relationship termed when a physician prescribes and compounds a medication for a patient?
What is the Beyond Use Date (BUD) for non-preserved aqueous dosage forms when stored in the refrigerator?
What is the Beyond Use Date (BUD) for non-preserved aqueous dosage forms when stored in the refrigerator?
Which factor is NOT directly influential in determining the BUD of a compounded preparation?
Which factor is NOT directly influential in determining the BUD of a compounded preparation?
What is the maximum BUD for preserved aqueous dosage forms?
What is the maximum BUD for preserved aqueous dosage forms?
Which of the following describes a requirement for assigning a BUD that exceeds USP recommendations?
Which of the following describes a requirement for assigning a BUD that exceeds USP recommendations?
Which of the following is a source of error in compounding?
Which of the following is a source of error in compounding?
What should be included in the meticulous calculations during compounding?
What should be included in the meticulous calculations during compounding?
Which guideline is recommended for the handling of hazardous medications according to USP?
Which guideline is recommended for the handling of hazardous medications according to USP?
During the compounding process, why is it important to verify critical processes like weighing and measuring?
During the compounding process, why is it important to verify critical processes like weighing and measuring?
What type of medications do NOT have a BUD established by USP guidelines?
What type of medications do NOT have a BUD established by USP guidelines?
What is a critical component of good compounding practice regarding personnel hygiene?
What is a critical component of good compounding practice regarding personnel hygiene?
What does the 'triple-check' method in accurate weighing and measuring entail?
What does the 'triple-check' method in accurate weighing and measuring entail?
Why should compounding be done one preparation at a time?
Why should compounding be done one preparation at a time?
What must be ensured when selecting containers for compounded preparations?
What must be ensured when selecting containers for compounded preparations?
Which element is NOT typically included on a compounded medication label?
Which element is NOT typically included on a compounded medication label?
What is emphasized when stating directions for use on medication labels?
What is emphasized when stating directions for use on medication labels?
When documenting a compounded preparation, which information is unique to the Compounding Record compared to the Master Formulation Record?
When documenting a compounded preparation, which information is unique to the Compounding Record compared to the Master Formulation Record?
Which of the following is NOT a requirement for a Material Safety Data Sheet (MSDS)?
Which of the following is NOT a requirement for a Material Safety Data Sheet (MSDS)?
What does the quality assurance program in compounding practice primarily ensure?
What does the quality assurance program in compounding practice primarily ensure?
What is the primary purpose of a Master Formulation Record?
What is the primary purpose of a Master Formulation Record?
Which area is NOT typically covered by Standard Operating Procedures (SOPs)?
Which area is NOT typically covered by Standard Operating Procedures (SOPs)?
Which of the following factors should pharmacists consider when adding information to directions for use?
Which of the following factors should pharmacists consider when adding information to directions for use?
What is the correct way to express strengths for topical preparations?
What is the correct way to express strengths for topical preparations?
During patient delivery and consultation, which aspect is essential to cover?
During patient delivery and consultation, which aspect is essential to cover?
When specifying frequency in directions for use, it is best to:
When specifying frequency in directions for use, it is best to:
What should be included when documenting the compounding process?
What should be included when documenting the compounding process?
Why is it important to express weights and volumes using metric units?
Why is it important to express weights and volumes using metric units?
Which detail is essential for quality control checks in a compounded preparation?
Which detail is essential for quality control checks in a compounded preparation?
What is a primary reason for compounding medications for pediatric patients?
What is a primary reason for compounding medications for pediatric patients?
Which patient group is specifically mentioned as benefitting from compounding for unique needs?
Which patient group is specifically mentioned as benefitting from compounding for unique needs?
What is one requirement for traditional compounding pharmacies under Section 503a?
What is one requirement for traditional compounding pharmacies under Section 503a?
What act addresses regulations for compounding pharmacies and established outsourcing facilities?
What act addresses regulations for compounding pharmacies and established outsourcing facilities?
Under Section 503b, outsourcing facilities are primarily focused on producing what type of preparations?
Under Section 503b, outsourcing facilities are primarily focused on producing what type of preparations?
What is one of the key differences between Section 503a and Section 503b pharmacies?
What is one of the key differences between Section 503a and Section 503b pharmacies?
Which of the following is NOT a requirement for bulk drug substances used in traditional compounding?
Which of the following is NOT a requirement for bulk drug substances used in traditional compounding?
What distinguishes compounding for hospice and palliative care from other types of compounding?
What distinguishes compounding for hospice and palliative care from other types of compounding?
What is the main purpose of USP standards for compounding?
What is the main purpose of USP standards for compounding?
What is the difference between 'beyond-use dating' and 'expiration dating'?
What is the difference between 'beyond-use dating' and 'expiration dating'?
Which of these is a characteristic of outsourcing facilities under Section 503b?
Which of these is a characteristic of outsourcing facilities under Section 503b?
Which of the following is a requirement for medications compounded in traditional pharmacies?
Which of the following is a requirement for medications compounded in traditional pharmacies?
What is a key aspect of the regulation of compounding pharmacies?
What is a key aspect of the regulation of compounding pharmacies?
What is the focus of Chapter 797 in USP standards?
What is the focus of Chapter 797 in USP standards?
Flashcards
Compounding
Compounding
The practice of combining and mixing drug ingredients to create customized medications for individual patients.
Compounding Triad
Compounding Triad
The relationship between a prescribing physician, the pharmacist preparing the medicine, and the patient receiving the compounded medication.
Compounding Diad
Compounding Diad
A relationship between a prescribing physician and the patient receiving the medication; where the physician also creates the prescription.
Compounding Preparation
Compounding Preparation
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Drug Product
Drug Product
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Reconstitution or Manipulation of Commercial Products
Reconstitution or Manipulation of Commercial Products
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Pharmacist Judgment
Pharmacist Judgment
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Beyond-Use Dates
Beyond-Use Dates
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Compounded Preparations
Compounded Preparations
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Why Compound?
Why Compound?
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Who Benefits from Compounding?
Who Benefits from Compounding?
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Who Regulates Compounding (Historically)?
Who Regulates Compounding (Historically)?
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FDA's Role in Compounding Regulation
FDA's Role in Compounding Regulation
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Why did the FDA increase its regulation in the compounding industry?
Why did the FDA increase its regulation in the compounding industry?
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Drug Quality and Security Act (DQSA)
Drug Quality and Security Act (DQSA)
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Section 503a and 503b in the DQSA
Section 503a and 503b in the DQSA
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Section 503a Compounding Pharmacies
Section 503a Compounding Pharmacies
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Section 503b Outsourcing Facilities
Section 503b Outsourcing Facilities
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Beyond-Use Date (BUD)
Beyond-Use Date (BUD)
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USP Standards for Compounding
USP Standards for Compounding
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USP Chapter 795: Non-Sterile Compounding
USP Chapter 795: Non-Sterile Compounding
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USP Chapter 797: Sterile Compounding
USP Chapter 797: Sterile Compounding
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Drug Degradation
Drug Degradation
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Dosage Form
Dosage Form
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Microbial Growth
Microbial Growth
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Container Interaction
Container Interaction
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Storage Conditions
Storage Conditions
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Duration of Therapy
Duration of Therapy
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Method of Preparation
Method of Preparation
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USP BUD Guidelines
USP BUD Guidelines
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Preserved Aqueous Dosage Forms BUD
Preserved Aqueous Dosage Forms BUD
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Non-preserved Aqueous Dosage Forms BUD
Non-preserved Aqueous Dosage Forms BUD
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Non-aqueous Oral Liquids BUD
Non-aqueous Oral Liquids BUD
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Other Non-aqueous Dosage Forms BUD
Other Non-aqueous Dosage Forms BUD
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Stability-indicating Assay
Stability-indicating Assay
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Prescription Evaluation
Prescription Evaluation
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What information is required on a compounded medication label?
What information is required on a compounded medication label?
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What are Standard Operating Procedures (SOPs)?
What are Standard Operating Procedures (SOPs)?
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What document is used as the starting point for creating a compounded preparation?
What document is used as the starting point for creating a compounded preparation?
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What document records the details of a compounded preparation for a specific patient?
What document records the details of a compounded preparation for a specific patient?
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What document is needed for each chemical used in compounding?
What document is needed for each chemical used in compounding?
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How should directions for use on a compounded medication label be written?
How should directions for use on a compounded medication label be written?
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What is a Standard Operating Procedure (SOP)?
What is a Standard Operating Procedure (SOP)?
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What document is used as a template for creating compounding records?
What document is used as a template for creating compounding records?
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What section of the Master Formulation Record details the ingredients and their quantities?
What section of the Master Formulation Record details the ingredients and their quantities?
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What critical information is included in the Material Safety Data Sheet (MSDS)?
What critical information is included in the Material Safety Data Sheet (MSDS)?
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What is the importance of patient counseling and information about compounded preparations during dispensing?
What is the importance of patient counseling and information about compounded preparations during dispensing?
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What is the significance of a Quality Assurance program in compounding practice?
What is the significance of a Quality Assurance program in compounding practice?
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What is the Beyond-Use Date on a compounded preparation?
What is the Beyond-Use Date on a compounded preparation?
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What is the purpose of Quality Control checks in compounding?
What is the purpose of Quality Control checks in compounding?
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What are some examples of areas covered by Standard Operating Procedures (SOPs) in a compounding pharmacy?
What are some examples of areas covered by Standard Operating Procedures (SOPs) in a compounding pharmacy?
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Study Notes
Compounding Pharmacy Overview
- Compounding involves combining drug ingredients to create customized medications for individual patients.
- Pharmacists, physicians, or outsourcing facilities can conduct compounding.
- Compounding tailors medications or devices based on a patient's needs.
- The compounding "triad" involves physician prescription, pharmacist preparation, and patient receipt.
- Physicians can compound, creating a "diad" patient-physician relationship.
- Compounding is primarily performed by pharmacists.
Scope of Compounding Activities
- Creates various dosage forms for human and animal use.
- Reconstitutes or modifies commercial products (e.g., antibiotic reconstitution).
- Adds flavorings to liquids—altering the original product.
- Prepares drugs or devices for research, teaching, and analysis.
Compounding vs. Manufacturing
- Compounding is tailored to individual patients and doesn't require FDA approval.
- Pharmacists use clinical and scientific expertise to evaluate safety/efficacy.
- Compounded products have beyond-use dates (BUDs) determined by various factors.
- Manufacturing follows FDA guidelines, requires pre-marketing studies, and yields mass-produced products.
Reasons for Compounding
- Addresses unique strength needs (e.g., pediatric doses).
- Improves patient compliance (e.g., flavored liquids, alternative routes).
- Addresses special population needs (pediatrics, geriatrics, specific needs).
- Addresses gender-specific needs (e.g., hormone therapy).
- Supports hospice/palliative care (symptom management).
- Serves veterinary medicine (animal considerations).
- Offers alternative routes of administration (topical pain management).
- Provides access to discontinued drugs.
- Fills gaps during drug shortages.
Regulation of Compounding
- State boards of pharmacy traditionally regulated compounding.
- FDA expanded its role after compounding-related incidents.
- HR 3204 (Drug Quality and Security Act) changed compounding regulations.
- This bill impacted both Section 503a and 503b compounding types.
Types of Compounding Pharmacies
Section 503a (Traditional Compounding Pharmacies)
- Primarily regulated by state boards of pharmacy.
- Subject to federal inspection if guidelines are violated.
- Patient-specific prescriptions are needed.
- Anticipatory compounding is allowed in limited cases.
- Compounded medications must comply with USP standards and FDA rules for bulk drug substances.
- FDA-withdrawn medications due to safety/efficacy concerns cannot be used.
- Cannot create near-identical copies of FDA-approved drugs unless significant benefits exist for patients.
- Demonstratively difficult-to-compound medications cannot be compounded.
Section 503b (Outsourcing Facilities)
- Focuses on producing large quantities of sterile preparations.
- Must register with the FDA.
- Doesn't require individual prescriptions.
- Supervised by a licensed pharmacist.
- Must comply with cGMP requirements, similar to drug manufacturers.
- Subject to regular FDA inspections.
USP Standards for Compounding
- USP/NF sets compounding standards, and FDA enforcement is involved.
- Important USP Chapters: 795 (non-sterile), 797 (sterile).
- USP Monographs provide guidelines for ingredients.
Beyond-Use Dating (BUD)
- The date after which a compounded preparation should no longer be used.
- Based on factors like degradation potential, microbial growth risk, and storage conditions.
- USP recommendations exist for determining BUD. Significant exceptions might necessitate more in-depth stability testing and a strong rationale.
Prescription Evaluation
- Pharmacists evaluate prescriptions for appropriateness (dosage, form, route).
Sources of Error in Compounding and Error Prevention
- Various errors are possible, from knowledge gaps to procedural mistakes.
- Prevention is crucial, including using meticulous calculations, careful compounding techniques, compliance with guidelines, and adhering to quality control measures.
Compounding Process Guidelines
- Authorized personnel, one preparation at a time, USP compliance, verifying critical aspects, and evaluating/packaging compounded items are key.
Labeling Requirements
- Compounded medication labels must meet state and federal regulations, including key information.
Directions for Use
- Clear, concise language for patients that avoid jargon is needed.
Drug Names, Weights, and Strengths
- Ensure correct and complete naming, weights, and strengths using universally understood terms.
Patient Delivery and Consultation
- Provide thorough patient counseling, document issues, and investigate any problems with the compounded preparation.
Quality Assurance in Compounding Practice
- Necessary for consistent high-quality preparations and practice using SOPs and monitoring procedures.
Standard Operating Procedures (SOPs)
- Detailed guidelines for compounding tasks, ensuring consistency, and addressing various aspects of compounding.
Master Formulation Record
- Provides step-by-step instructions for compounding a specific formulation (rather than individual patient).
Compounding Record
- Documents each patient's compounded preparation using information like ingredient details, calculations, dates, and personnel signatures.
Material Safety Data Sheet (MSDS)
- Provides detailed information to ensure safe handling, storage, and use of chemicals.
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Description
This quiz provides an overview of compounding pharmacy practices, detailing how customized medications are created to meet individual patient needs. Learn about the roles of pharmacists and physicians in compounding, the various dosage forms, and the key differences between compounding and manufacturing. Test your knowledge on this essential aspect of pharmacy.
