USP Chapters & Compounding Laws Overview Questions and Answers Already Passed Latest
Update 2025-2026
USP - AnswersSets federally recognized standards for identity, strength, quality, purity.
Federal Food, Drug, and Cosmetic Act (FDCA) - AnswersOne of the enforceable standards under
which USP operates.
USP General Notices - AnswersBroad rules on definitions, calculations, etc.
USP General Chapters - AnswersSpecific methods & standards (e.g. <795>, <797>, <800>,
<825>).
USP Monographs - AnswersDetailed identity & quality tests for specific drugs.
USP Compounding Compendium - AnswersCollection of over 200 compound monographs.
Enforcement of USP standards - AnswersDone by state boards of pharmacy, FDA, and
accrediting agencies.
503A Pharmacies - AnswersTraditional, patient-specific compounding.
503B Outsourcing Facilities - AnswersNot patient-specific, regulated by FDA, must follow
cGMPs.
Drug Quality and Security Act (DQSA) - AnswersSplit compounding rules into 503A vs 503B in
2013.
USP <797> - AnswersApplies to sterile compounding.
USP <795> - AnswersApplies to all nonsterile preparations: oral liquids, capsules, ointments,
creams, suppositories, etc.
Training & Competency for Compounding - AnswersAll compounders must be trained and
demonstrate competency initially and annually.
Competency includes - AnswersHand hygiene, measuring and mixing, labeling and
documentation, proper use of equipment.
Designated Person - AnswersResponsible for documenting competency in compounding.
Compounding Facilities Requirements - AnswersMust have a designated compounding area,
sink with hot & cold water, and dedicated area for hazardous drug compounding.
Personal Protective Equipment (PPE) - AnswersIncludes gloves for all compounding activities,
gowns, masks, shoe covers based on risk level.
Hand hygiene requirement - AnswersWash for at least 30 seconds before compounding.
, Cleaning & Sanitizing - AnswersMust be done routinely and when contamination is known or
suspected.
Compounding area requirements - AnswersMust include a sink, dedicated space, and access
limits.
Competency assessment frequency - AnswersEvery 12 months for nonsterile compounding.
Hand washing duration - AnswersMust wash hands for 30 seconds before compounding.
Standard Operating Procedures (SOPs) - AnswersRequired for preparation procedures,
equipment cleaning & calibration, quality control & verification steps, and handling hazardous
drugs if applicable.
Material Safety Data Sheets (MSDS) - AnswersMust be included for chemicals used in
compounding.
Compounding Record (CR) - AnswersMust be kept for each batch and include the name of the
compound & dosage form, ingredients used & quantities, date of prep, assigned BUD, names of
people involved, reference to Master Formulation Record (MFR), and results of quality control
tests.
Beyond-Use Dating (BUD) - AnswersDate after which the compound should NOT be used,
determined by stability, API degradation, and microbial contamination risk.
BUD for non-aqueous formulations - Answers180 days.
BUD for water-containing oral formulations - Answers14 days.
BUD for water-containing topical formulations - Answers30 days.
Purified Water USP - AnswersType of water that must be used in compounding, not tap water.
Certificate of Analysis (CoA) - AnswersRequired if an ingredient isn't USP grade.
Labeling Requirements for Compounds - AnswersEach compound must be labeled with
assigned internal identification number, active ingredient names and strengths, storage
conditions, BUD, route of administration, any special handling instructions, and pharmacy
contact info if dispensed outside the facility.
CSPs - AnswersCompounded Sterile Preparations must follow both USP <797> and USP <800>
for hazardous drugs.
Immediate-use CSPs - AnswersHave a 4-hour BUD.
Single-dose vials used outside ISO 5 - AnswersHave a 6-hour BUD.
Sterile Compounding Area Requirements - AnswersMust be cleanable & sanitized, maintain
Update 2025-2026
USP - AnswersSets federally recognized standards for identity, strength, quality, purity.
Federal Food, Drug, and Cosmetic Act (FDCA) - AnswersOne of the enforceable standards under
which USP operates.
USP General Notices - AnswersBroad rules on definitions, calculations, etc.
USP General Chapters - AnswersSpecific methods & standards (e.g. <795>, <797>, <800>,
<825>).
USP Monographs - AnswersDetailed identity & quality tests for specific drugs.
USP Compounding Compendium - AnswersCollection of over 200 compound monographs.
Enforcement of USP standards - AnswersDone by state boards of pharmacy, FDA, and
accrediting agencies.
503A Pharmacies - AnswersTraditional, patient-specific compounding.
503B Outsourcing Facilities - AnswersNot patient-specific, regulated by FDA, must follow
cGMPs.
Drug Quality and Security Act (DQSA) - AnswersSplit compounding rules into 503A vs 503B in
2013.
USP <797> - AnswersApplies to sterile compounding.
USP <795> - AnswersApplies to all nonsterile preparations: oral liquids, capsules, ointments,
creams, suppositories, etc.
Training & Competency for Compounding - AnswersAll compounders must be trained and
demonstrate competency initially and annually.
Competency includes - AnswersHand hygiene, measuring and mixing, labeling and
documentation, proper use of equipment.
Designated Person - AnswersResponsible for documenting competency in compounding.
Compounding Facilities Requirements - AnswersMust have a designated compounding area,
sink with hot & cold water, and dedicated area for hazardous drug compounding.
Personal Protective Equipment (PPE) - AnswersIncludes gloves for all compounding activities,
gowns, masks, shoe covers based on risk level.
Hand hygiene requirement - AnswersWash for at least 30 seconds before compounding.
, Cleaning & Sanitizing - AnswersMust be done routinely and when contamination is known or
suspected.
Compounding area requirements - AnswersMust include a sink, dedicated space, and access
limits.
Competency assessment frequency - AnswersEvery 12 months for nonsterile compounding.
Hand washing duration - AnswersMust wash hands for 30 seconds before compounding.
Standard Operating Procedures (SOPs) - AnswersRequired for preparation procedures,
equipment cleaning & calibration, quality control & verification steps, and handling hazardous
drugs if applicable.
Material Safety Data Sheets (MSDS) - AnswersMust be included for chemicals used in
compounding.
Compounding Record (CR) - AnswersMust be kept for each batch and include the name of the
compound & dosage form, ingredients used & quantities, date of prep, assigned BUD, names of
people involved, reference to Master Formulation Record (MFR), and results of quality control
tests.
Beyond-Use Dating (BUD) - AnswersDate after which the compound should NOT be used,
determined by stability, API degradation, and microbial contamination risk.
BUD for non-aqueous formulations - Answers180 days.
BUD for water-containing oral formulations - Answers14 days.
BUD for water-containing topical formulations - Answers30 days.
Purified Water USP - AnswersType of water that must be used in compounding, not tap water.
Certificate of Analysis (CoA) - AnswersRequired if an ingredient isn't USP grade.
Labeling Requirements for Compounds - AnswersEach compound must be labeled with
assigned internal identification number, active ingredient names and strengths, storage
conditions, BUD, route of administration, any special handling instructions, and pharmacy
contact info if dispensed outside the facility.
CSPs - AnswersCompounded Sterile Preparations must follow both USP <797> and USP <800>
for hazardous drugs.
Immediate-use CSPs - AnswersHave a 4-hour BUD.
Single-dose vials used outside ISO 5 - AnswersHave a 6-hour BUD.
Sterile Compounding Area Requirements - AnswersMust be cleanable & sanitized, maintain
