Compounding

Which USP chapters are enforceable as law under 26-4-86?

• USP chapters <1000

Which USP chapter covers non sterile compounding?

• USP 795

Which USP chapter covers hazardous drug compounding?

• USP 800

Does 26-4-86 allow practitioners to compound drugs for their own patients?

• yes, it allows practitioners to compound drugs for administering or dispensing to their own patients

What is the purpose of the rules and regulations under 26-4-86?

• to ensure compliance with USP standards

What type of compounding does 503A refer to?

• traditional compounding

Is bulk compounding allowed under 503A?

• no, only compounding pursuant to individual prescriptions is allowed

Must compounding under 503A be patient specific?

• Yes, it has to be patient specific

Who regulates 503A compounding facilities?

• state board of pharmacy

Does majority of compounding fall under 503A or 503B?

• the majority falls under 503A

What type of compounding facility is described under 503B?

• outsourcing facility

Is bulk compounding allowed under 503B?

• yes, bulk compounding is allowed

Are prescriptions required to be patient specific under 503B?

• No, 503B allows non patient specific compounding

What manufacturing standards must 503B facilities follow?

• current good manufacturing ractices (CGMP)

Who regulates 503B outsourcing facilities?

• FDA and state board of pharmacy

Can 503B facilities compound schedule II-V controlled susbtances?

• No, they cannot compound schedule II-V controlled substances

Who do 503B outsourcing facilities have to be registered with?

• FDA

Is a prescription required for compounds made in bulk for office use in 503B facilitities?

• No, prescriptions are not required

Who can compound?

• pharmacist

• technicians or interns ( under supervision)

• physicians

• other healthcare practitioners

What components make up a compound?

• active ingredients + excipients

Where can you find a list of ingredients acceptable for use in compounds?

• in USP-NF or food chemicals codex

How do you determine an expiration date for a component of a compound without an expiration date?

• pharmacist are allowed to assign expiration dates , but it has to be < 3 years from the date of receipt.

• the label has to contain: date of receipt and assigned expiration date

What are some types of inactive ingredients?

• fillers

• diluents

• sweeteners

• sustained release matrices

• coloring agents

• preservatives

Which inactive ingredients can cause adverse effects in some patients?

• phenylalanine with phenylketonuria

• sulfites ( sulfite sensitivity)

Cana compound product be a copy of a commercially available product?

• No, it cannot be a copy of a commercially available product

Can a product that is withdrawn or removed from the market by the FDA be comounded?

• No

Is non-patient specific compounding for office use by a practitioner allowed?

• No, non patient specific preparations cannot be distributed for office use

In GA, can pharmacists sell compounded preparations to veterinarias?

• Yes, for administration or emergency dispensing to their patients

What does emergency dispensing mean under GA veterinary compounding rules?

• no more than a 96 hour supply dispensed for urgent conditions

What is the maximum percentage of pharmacy’s compounded preparations that may be distributed to a veterinarian for office administration or emergency dispensing per calendar year?

• 5% of the pharmacy’s total compounded production

What type of agreement must a pharmacist have with a veterinarian before distributing compounded preparations for emergency dispensing or office use?

• a written agreement

What labeling phrase must be included on compounded preparations provided to veterinarians in GA?

• by purchase order, not by prescription

• for office use administration or emergency dispensing by a veterinarian only - not for resale

What is the role of the designated person in a compounding facility?

• they are responsible and accountable for the performance and operation of the facility and personnel in the preparation of compounded sterile products

Must the designated person be the pharmacist in charge?

• no they are likely the PIC but not required to be

USP 795 applies to which type of patients?

• both humans and animal patients

Who does USP 795 apply to?

• all compounders

What type of activities are considered non sterile compounding under USP 795?

• combining, admixing, diluting, pooling, reconstituting, to create a non sterile product

Which activities are not considered compounding under USP 795?

• repackaging, tablet splitting, manufacturer labeled reconstitution, or administration

What is the acceptable variability range for the strength of a non sterile compound product under USP 795?

• ± 10% from the intended product strength

List dosage forms included under USP795:

• solid oral medications

• liquid oral medications

• topicals

• rectal

• vaginal

• otic

• nasal/sinus sprays

How often must training be conducted and documented for compounding personnel?

• initially and every 12 months

What must be done with the documentation of traiining?

• myst be recorded and maintained

What types of clothing must compound personnel wear?

• clean clothing appropriate to the type of compounding performed: hair bonnets, gowns, gloves, masks, shoes, aprons

Why must compounding personnel wea proper garb?

• to protect themselves from chemical exposures and to prevent drug contamination

How log should hands and forearms be washed with soap and water?

• at least 30 seonds

Are alcohol based hand sanitizers alone sufficient for hand hygeine during compounding?

No, they are not sufficient on their own

After washing , how should your hands and forearms be dried?

• with disposable towels or wipes, and they must be completely dry before putting on gloves

Are gloves required for non sterile compouding?

• yes, gloves are required for all compounding activities

What is requires of the space used for compounding?

• it must be specifically designated for compounding and separated from areas not directly related to compounding

What materials must be cleanable and kept clean in a compounding area?

• ceiling, walls, floors, fixtures, shelving, counters, and cabinets

Is carpet allowed in a compounding area?

• no carpet is not allowed

Where must all components, equipment, and containers be stored?

• off the floor

What must compounding facilities establish and follow in regars to compounded non sterile products?

• written standard operating procedures

What must SOPs cover?

• all aspects of the compounding operation

What is the purpose of the master formulation record?

• it provides standardized recipe for compounding a preparation

What must be included regarding the name of the preparation?

• the official or assigned name, strength, and dosage form

What type of calculations must be included in the master formulation record?

• calculations needed to determine and verify quantities of components and doses of active ingredients

What must be included about ingredients in master formulation?

• a description of all ingredients and their quantities

What information must be provided about compatibility and stability in the master formulation?

• compatibility and stability information, including references when available

What equipment information must be listed on master formulation?

• equipment needed to prepare the preparation, when appropriate

What specific mixing instructions must be listed?

• equipment needed to prepare the preparation when appropriate

What specific mixing instructions should be included on master formulation?

• Order of mixing

• Mixing temperatures/environmental controls

• Duration of mixing

• Other replication-critical factors

What dispensing information must be included on master formulation?

• container used in dispensing

What storage instructions must be documented on master formulation?

• oackaging and storage requirements

What final preparation detail must be described?

• description of the final preparation

What must be included regarding quality control on the master formulation?

• quality control procedures and expected results

What is the purpose of the compounding record?

• to document the compounding of each compounded product

What document can serve as basis for the compounding record?

• master formulation record

How can the master formulation record be used to create a compounding record?

• a copy can be made with spaces for recording the compound specific data

What name information must be included in the Compounding Record?

• The official or assigned name, strength, and dosage of the preparation.

What document must the Compounding Record reference?

• The Master Formulation Record.

What component details must be included?

• Names and quantities, sources, lot numbers, and expiration dates of all components.

What quantity-related information must be documented?

• The total quantity compounded.

Who must be identified in the Compounding Record?

• The person who prepared the preparation

Who must be identified in the Compounding Record?

• The person who prepared the preparation

• The person who performed quality control

• The compounder who approved the preparation

What date-related information is required?

• The date of preparation.

What number must be assigned and included for tracking purposes?

• The control or prescription number.

What dating information must be included to ensure product stability?

• The assigned BUD (beyond-use date).

What labeling must be attached or included?

• A duplicate label as described in the Master Formulation Record.

What description must be provided about the compounded product?

• A description of the final preparation.

What results must be recorded from quality control procedures?

• Examples include weight range of filled capsules or pH of aqueous liquids.

What must be documented if there are any problems?

• Any quality control issues

• Adverse reactions

• Preparation problems reported by the patient or caregiver

Who must inspect the compounded product before release?

• A pharmacist (RPh).

What aspects of the preparation must be visually inspected during release testing?

• Physical appearance

• Labeling match with prescription/order and the compounding record

What unique identifier must be on the CNSP label?

• The assigned internal identification number (e.g., prescription or lot number).

What type of ingredient information must be on the label?

• The chemical and/or generic names and the amounts or concentrations of active ingredients.

What form of the preparation must be indicated on the label?

• The dosage form (e.g., capsule, solution, ointment).

What quantity information must be listed on the CNSP label?

• The total amount or volume of the compounded product.

What environmental information must be on the label?

• he storage conditions (e.g., room temp, refrigerated).

What dating information must be displayed on the label?

• The BUD (Beyond-Use Date).

What does BUD stand for?

• beyond use date

How does BUD differ from expiration date?

• The expiration date comes from the manufacturer and applies to commercial products; the BUD is assigned to compounded preparations and considers stability once mixed.

Can a BUD extend beyond the expiration date of a component?

• No, a BUD cannot exceed the expiration date of any component used in the compounded preparation.

What is the BUD for solid dosage forms (e.g., capsules or tablets) stored at controlled room temperature?

• 180 days

What is the BUD for preserved aqueous dosage forms stored at controlled room temperature?

• 35 days

What is the BUD for non-preserved aqueous dosage forms stored in a refrigerator?

• 14 days

What is the BUD for nonaqueous dosage forms stored at controlled room temperature?

• 90 days

What water activity (Aw) value classifies a dosage form as aqueous?

• Aw > 0.6

What are examples of aqueous formulations?

• Emulsions, gels, creams, solutions, sprays, and suspensions.

What water activity (Aw) value classifies a dosage form as non-aqueous?

• Aw < 0.6