Compounding Best Practices

What is a Beyond-Use Date (BUD)?

The time a compounded medication remains stable & effective. Different from manufacturer expiration dates

What are Standard Operating Procedures (SOPs) in compounding?

Written instructions that outline consistent methods and processes to ensure safety, accuracy, and quality in compounding.

What is a Compounding Record (CR)?

A record of an individual compounded preparation, documenting date, quantity, lot numbers, BUD, personnel, and verification.

What is a Master Formulation Record (MFR) in compounding?

A detailed recipe for a compounded preparation, including ingredients, quantities, equipment, instructions, and quality control steps.

How are BUDs different from expiration dates?

BUDs apply to compounded meds and depend on risk level & storage. Expiration dates are set by manufacturers for unopened products.

How are BUDs determined?

By risk level of compounding and storage conditions (room temp, fridge, freezer). Cannot exceed the earliest expiration date of any ingredient.

What is the USP <795> BUD for non-aqueous formulations (capsules, oils)?

6 months

What is the USP <795> BUD for oral formulations containing water?

14 days refrigerated

What is the USP <795> BUD for topical formulations with water (e.g., creams, ointments)?

What are the USP <797> BUDs for Immediate Use products?

Room temp: 1 hour | Fridge: N/A | Freezer: N/A

What are the USP <797> BUDs for Low Risk (12-hour) products?

Room temp: 12 hours | Fridge: 12 hours | Freezer: N/A

What are the USP <797> BUDs for standard Low Risk products?

Room temp: 48 hours | Fridge: 14 days | Freezer: 45 days

What are the USP <797> BUDs for Medium Risk products?

Room temp: 30 hours | Fridge: 9 days | Freezer: 45 days

What are the USP <797> BUDs for High Risk products?

Room temp: 24 hours | Fridge: 3 days | Freezer: 45 days

What information must be included on a compounded medication label?

• Pharmacy name, address, phone

• Patient name

• Prescription & compounding date

• Prescriber name

• Medication name, additives, directions, BUD

• Pharmacist & technician ID

How should compounded products be inspected?

Check for incompatibilities (precipitates, coring). Use a lightbox with black & white backgrounds. Discard & notify pharmacist if incompatibility found.

What records must be kept for compounding documentation?

Master formulation record

• Compounding record

• SOPs

• Ingredient records & safety data sheets

What details must documentation capture for each compounded product?

- Name, strength, dosage form, route

• Date, quantity, BUD

• Preparer & checker

• Ingredients, calculations, equipment, method

• Quality control procedures