usp 795 non-sterile compounding and consultation

Q: What does USP stand for?

A: United States Pharmacopeia.

Q: What does NF stand for?

A: National Formulary.

Q: What is USP <795>?

A: Standards for non-sterile compounding.

Q: Which USP chapters are required?

A: Chapters under 1000.

Q: Which USP chapters are informational?

A: Chapters 1000–1999.

Q: Which USP chapters are dietary supplements?

A: Chapters 2000 and above

Q: What is non-sterile compounding?

A: Combining, admixing, diluting, pooling, or otherwise altering a drug/bulk drug substance to create a non-sterile medication (outside manufacturer labeling).

A pediatric patient requires a liquid formulation of a drug that is only available in tablet form. What USP <795> considerations must be addressed before compounding this medication?

Must evaluate drug stability in liquid form, ensure accurate dosing, and document the compounding process. USP <795> requires appropriate beyond-use dating and labeling.

Q: What are some reasons to compound.

1. Pediatric doses require smaller doses of adult strength medication

2. Special flavoring to make medication palatable

3. Converting dosage forms: Patient requires oral solution or suspension

4. Sensitive to inactive ingredients: dyes, preservatives, flavoring agents

5. Hospice patients pain medication

6. Off label drug uses which are not available in required dosages

7. Medications not commercially available

8. Special dosing/dosage forms for animals

Q: What does USP <795> Standards aim to prevent?

A: excessive microbial contamination, variability in strength, physical and chemical incompatibility, physical and chemical contaminants, and use of poor-quality ingredients.

Q: What are some products of USP <795> ?

A: 1. Oral suspensions and solutions

2. Capsules, tablets, lozenges/troches (cough drop/gummy)

3. Topical (cream)

4. Suppositories

5. Rectal and vaginal

6. Nasal products

7. Otic (ear) products

Q: What is NOT considered products of USP <795> ?

A: 1. Reconstitution

2. Repackaging

3. Splitting tablets

4. Preparing a dose to be given within 4 hours

Q: Define beyond-use date (BUD).

A: The date/time after which a compounded preparation cannot be used and must be discarded. Determined from the date the preparation is compounded.

Q: What are exceptions for beyond-use date (BUD).

A: 1. If component had an expiration date or BUD earlier than the recommended BUD ; the earliest date MUST BE USED as the BUD

2. If there is a USP-NF monograph for the CNSP (compounding nonsteril product), the BUD must not excess what is stated on the monograph.

3. BUDs for aqueous and non-aqueous dosage forms may be extended up to a max of 180 days, IF there is stability information available using a stability indicating assay, CNSP formulation, and material of composition of the container closure that will be used

Q: What is the BUD for non-preserved aqueous dosage forms (e.g., gels, creams, suspensions)?

A: 14 days, refrigerated.

Q: What is the dosage form for a_w > 60 with a BUD of 14 days, refrigerated

A: Non-preserved aqueous

Q: What is the dosage form for a_w > 60 with a BUD of 35 days, controlled room temp or refrigerated

A: preserved aqueous

Q: What is the dosage form for a_w < 60 with a BUD of 90 days, controlled room temp or refrigerated

A: oral liquids (non-aqueous)

Q: What is the dosage form for a_w < 60 with a BUD of 180 days, controlled room temp or refrigerated

A: other non-aqueous

Q: What are examples of non-preserved and preserved aqueous dosage forms

A: gels, creams, sprays, solutions, suspensions

Q: What are examples of oral liquids (non-aqueous) dosage forms

A: fixed oil suspensions

Q: What are examples of other non-aqueous dosage forms

A: capsules, tablets, granules, powders, troches, suppositories, non-aqueous topical

Q: List the 5 stability parameters of CNSP.

A: Chemical, physical, microbiological, therapeutic, toxicological.

Q: What is Quality Assurance (QA)?

A: system of procedures, activities, and oversight that ensures that the compounding process consistently meets quality standards

Q: What is Quality Control (QC)?

A: Testing procedures to evaluate the quality of the compounded formulation.

Q: What are physical changes indicating instability within capsules

1. Change in physical appearance or consistency of capsule or its contents (example: hardening or softening of the shell)

2. Discoloration

3. Expansion or distortion of the gelatin capsule

Q: What are physical changes indicating instability within powders

1. Caking or discoloration instead of free flowing

2. Release or pressure on opening of container

3. Indicative of bacterial or other degradation

Q: What are physical changes indicating instability within solutions/elixirs, syrups

1. Precipitation

2. Discoloration

3. Haziness

4. Gas formation resulting from microbial growth

Q: What are physical changes indicating instability within emulsions (mixture of oil and water like medications)

1. Breaking

2. Creaming

Q: What are physical changes indicating instability within suspensions

1. Caking

2. Difficulty in re-suspending

3. Crystal growth

Q: What are physical changes indicating instability within ointments

1. Change in consistency and separation of liquid

2. If contained and formation of granules or grittiness

3. Drying

Q: What are physical changes indicating instability within creams

1. Emulsion breakage

2. Crystal growth

3. Shrinkage caused by evaporation of water

4. Grows microbial contamination

Q: What are physical changes indicating instability within suppositories

1. Excessive softening

2. Drying

3. Hardening

4. Shriveling

5. Evidence of oil stains on packaging

Q: What are physical changes indicating instability within gels

1. Shrinkage

2. Separation of liquid from the gel

3. Discoloration

4. Microbial contamination

Q: What are physical changes indicating instability within gels

1. Softening or hardening

2. Crystallization

3. Microbial contamination

4. Discoloration

Q: What are physical changes indicating instability within sterile products

1. Discoloration

2. Haziness

3. Precipitation

Q: What is a Master Formulation Record?

Detailed record of procedures that describes how the CNSP to be prepared. Must be CREATED for each unique formulation.

1. Name, strength, and dosage of CNSP

2. Name & amounts of all components

3. Container-closure system(s)

4. Complete instructions for preparation

5. Physical description of CNSP

6. BUD & storage requirements

7. Calculations (if any)

8. Labeling requirements (auxiliary label info)

9. Quality control procedures

10. Any other information regarding compounding process

Q: What is a Compounding Record?

Documentation of the compounding of each CNSP. Must be COMPLETED each time a product is compounded.

1. Name, strength or activity, and dosage form

2. Date and time of preparation

3. Identifying number (ex: prescription #)

4. Names of persons involved in compounding and verifying

5. Name, manufactur, lot #, expiration date of each ingredient

6. Amount used of each ingredient

7. Total quantity compounded

8. Assigned BUD & storage requirements

9. Any calculations

10. Physical description

11. Quality control results (ex: pH)

12. Master formulation record reference

A pharmacy technician is preparing a banana-flavored oral suspension of amlodipine for a pediatric patient. The pharmacy has compounded this same preparation multiple times in the past using a standardized recipe. Today, the technician is preparing a single batch for one patient.

Which record(s) must be used in this situation?
A. Only a Master Formulation Record
B. Only a Compounding Record
C. Both a Master Formulation Record and a Compounding Record
D. Neither record is required

C. Both a Master Formulation Record and a Compounding Record
Explanation:

• The Master Formulation Record is required because the pharmacy uses a standardized recipe for repeated compounding.

• The Compounding Record is required because the technician is preparing a specific batch for a patient today, and USP <795> mandates documentation of each compounding event.

What are some compounding methods for CNSP?

trituration

spatulation

levigation

geometric diluation

Q: What is trituration?

A: Dry grinding to reduce particle size.

Q: What is spatulation?

A: Mixing powders with a spatula, often on an ointment slab.

Q: What is levigation?

A: Wet grinding

- Used to reduce the particle size of a powder by triturating it with a solvent in which the ingredient is insoluble (ex: using mineral oil or glycerin)

- Reduces grittiness of the final formulation

- Typically done before the drug is incorporated into suspension, ointment, or suppository base

- Levigating agents:

1. Glycerin

2. Propylene glycol

3. Mineral oil

Q: What is geometric dilution?

A: - Used to mix two powders of different quantities

- The smaller amount of the powder is diluted in steps by additions of the larger amount of powder

- Smaller amount is triturated with an approximate equal portion of the larger amount of powder in a mortar → then, this triturate is mixed with an approximately equal portion of the remaining larger amount → process continued until all of the powders have been mixed

Q: why compound for oral solutions/syrups

A: Useful for patients with difficulty swallowing solid dosage forms

Help to prevent patients from “cheeking” tablets or capsules

Q: things to know about compounding oral solutions/syrups

1. Small particles dissolve faster than large particles

2. Stirring increases the dissolution rate of a drug

3. Viscous liquids will decrease the dissolution rate of a drug

4. Increase in temperature leads to an increase in the solubility of a drug

5. pH adjustments can increase solubility

6. addition of an electrolyte can increase or decrease the solubility of a nonelectrolyte drug

Q: things to know about compounding suspensions

A: Two phased system consisting of a finely divided solid dispersed in a solid, liquid, or gas.

Suspensions are appropriate when the drug to be incorporated is not sufficiently soluble in an ordinary solvent or co-solvents system.

A good suspension ensures that the drug is uniformly dispersed throughout the vehicle. Also, can be re-suspended easily, not too thick, doesn’t care.

Q: what are the compounding steps for a suspension

A:

1. Prepare by reducing particle size of active ingredient as much as possible (trituration)

2. Thoroughly wet insoluble material before mixing with vehicle

3. Use the minimal amount of wetting agent required to make paste (levigation)

4. Once thick paste created, add vehicle with constant stirring (geometric dilution??)

Q: what are some acceptable flavor aspects

A: - immediate flavor identity

• rapid full flavor development

• acceptable mouth feel

• short aftertaste

• no undesirable sensations

Q: what are some flavoring techniques

A: - blending: using a flavor the blends drug taste

• overshadowing: use of a flavor with greater intensity and longer residence time in the mouth than the original preparation

• physical methods: formulation of an insoluble compound; use of effervescent additives; emulsification of oils; use of high-viscosity fluids

• chemical methods: absorbing or complexing the drug with an ingredient that eliminates the undersirable taste

• physiological methods: use of densitizers to provide cooling sensation, anesthetic effects, or mild pain reaction

Q: what is the purpose of compounding topicals

A: Protect injured area from environment and permit skin to rejuvenate

Provide skin with hydration or to produce an emollient effect

To convey a medication to the skin for a specific effect, topically or systemically

Q: what special labeling and patient counseling should be considered for CNSP?

A:

• labeling should include a statement indication medication is compounded

• include any special storage and handling information

• instruct patients to report any adverse events

  • instruct patients to observe and report any changes in the physical characteristics of the compound

Q: Potassium Bromide Capsules (a_w < 0.60)

-potassium bromide powder, exp 12/25

-lactose, exp 9/26

what will be the BUD

A: BUD is 12/25

Q: Can I compound this product?

Clients mother is in a nursing home and cannot safely swallow tablets or capsules. the mothers blood pressure medication only comes in a tablet form that cannot be crushed. the physician wrote a prescription for an oral suspension of her blood pressure medication.

A: yes you can compound this product. her condition is met under USP <795>; pt cannot safely swallow the medication and it cannot be crushed so must be compounded into an oral suspension.

Q1:
A pharmacist compounds an oral aqueous suspension of an antibiotic without preservatives. What is the BUD?

A: 14 days, refrigerated

A pharmacist compounds an oral solution on October 1st. It is a non-preserved aqueous preparation. What date should be assigned as the BUD?

A: October 15th (14 days refrigerated).

what are the pharmacist patient care process - dispensing

collect

assess

plan

implement

follow-up: monitor and evaluate

collaborate

communicate

document

what are board requirements for consultations

• must provide consultations

• pt may refuse consultation - must document this

• mail order (for pt/agent not present) - provide written notice for a right to a consultation, and give phone unmber for pt to call

what must the pharmacy consultations contain

directions for usage

storage

importance of compliance

warnings/precautions - side effects, interactions, rx

what are some of the basic requirements for pharmacy consultation

• name and description of mediation

• route, dosage form, dosage, duration of therapy

• special directions for use and storage

• precautions for preparation and administration by pt

• monitoring parameters

• refill information

• therapeutic contraindications

• how to avoid/handle interactions and side effects

  • what to do if a dose is missed

what are some kind of questions to avoid in pharmacy consultations

• close-ended questions: yes/no questions

  • ask open ended questions that require more of an answer

what are the prime questions in drug consultations

• what did your physician tell you this medication is for?

• how did your physician tell you to take this medication?

• what did your physician tell you to expect when you take this medication?

what must be included in the closing of a consultation

• ask if pt has any questions

• address any issues or concerns pt may have

• have pt repeat information back to you to confirm understanding

• assess need for follow up