CPJE Secrets 2026: Drug Compounding Regulations

Compounding Facts

Compounding: the act of combining/altering ingredients to create medicines to meet unique medical needs of individual patients. Includes altering dosage form, combining components or active ingredients.

• No drug preparation shall be compounded prior to receipt of a valid Rx (AKA “you can’t just make drugs for yourself in your garage”)

• Anticipatory Compounding: Pharmacies can compound in advance of receipt of patient-specific prescription (in limited amounts) to ensure continuity of care and for prescriber’s office use only.

• Compounded drug is NOT a copy of something on the market unless the product is in short supply and medical need exists

• Before compounding, a master formula document must be written. Include in/active ingredients, equipment, BUD, compounding steps, quality reviews, post-compounding procedures, storage and handling.

• Review policies and procedures annually by PIC.

Areas and Air Quality

Compounding aseptic isolators (CAI) and compounding aseptic containment isolators (CACI) are now simply called Restricted Access Barrier Systems (RABS) and they must be placed in the cleanroom suite to get Category 2 BUDs.

Cleanroom Suite: Per 2019 USP 797, must contain anteroom and buffer room

Anteroom: ISO Class 8 or better air quality, adjacent to cleanroom, for hand hygiene (has sink), garbing, staging of components

Buffer Area: ISO Class 7 or better air quality, between Anteroom and PEC

Primary Engineering Control (PEC): device that provides ISO Class 5 or better quality for sterile compounding

Sterile Compounding: each ISO area certified every 6 months and certification records kept for at least 3 years

USP Compounding Standards

Goal Temperatures

Controlled Fridge: 2-8 ^oC

Freezer: -25 to -10 ^oC

Room: 20-25 ^oC

USP Chapters

<800>: Hazardous Drugs (antineoplastics, carcinogens)

<825>: Radiopharmaceuticals (nuclear pharmacy)

<795>: Nonsterile Compounding

<797>: Sterile Compounding

USP <795> Nonsterile Compounding BUD/Storage Guidelines

Aqueous Dosage Forms (aw 0.6 or higher) - emulsions, gels, creams, solutions, sprays, suspensions

Non-preserved aqueous: 14 days in fridge

Preserved aqueous: 35 days in fridge/room temp

Nonaqueous Dosage Forms (aw 0.6 or less)

Oral liquids (nonaqueous): 90 days in fridge/room temp

Other Forms (caps, tabs, powders, etc.): 180 days in fridge/room temp

USP <797> Sterile Compounding BUD/Storage Guidelines

IVs, irrigations, eyedrops, eardrops on perforated eardrums, inhalers, repackaging, allergenic extracts.

Immediate Use/For-Administration Formulations

Can be prepped in ambient air.

Mixed by nurses, anesthesia staff, paramedics, nuclear med techs, imaging techs

Requires aseptic technique. Administer within 4 hours of mixing and can only have max 3 sterile components

Allergenic Extracts and Radiopharmaceuticals

Prep in special areas.

• AEs in AE Compounding Areas (AECA) per <797>

• RPs in Segregated RP Processing Area (SRPA) per <825>

Category 1 CSPs

Prepared in segregated compounding area (SCA).

• Hazardous in Containment SCA, follow facility requirements

• Non-hazardous in regular SCA at room temperature (low humidity)

BUDs: 12 hours at room temperature and 24 hours in fridge

Category 2 CSPs

Prepared in a cleanroom suite (anteroom + buffer area)

• Hazardous: positive anteroom and negative buffer, ISO 7 or better

  • BUDs: 4 days room temp | 10 days fridge | 45 days freezer

• Nonhazardous: positive anteroom and positive buffer, ISO 8 or better

  • BUDs: 24 hours room temp | 4 days fridge | 45 days freezer

Category 3 CSPs exist, but must be prepped in a cleanroom suite with special pressure requirements.

Recordkeeping

Keep ALL records for at least 3 years

• Master Formula Document

• Compounding Log

  • QA, Certification records, staff training

Compound Labelling

All Preparations

Name of compounding and dispensing pharmacy (if different)

Active ingredient/s (brand/generic)

Strength/volume/weight of final preparation

Lot #

BUD

If space permits, storage, how to handle/admin, infusion rate, date compounded

Sterile Formulations

Telephone # of pharmacy (not required for inpatient administration)

Instructions for storage, handling, admin

Hazardous Formulations

“Chemotherapy- Dispose of Properly” OR “Hazardous- Dispose of Properly”

Sterile Compounding Procedure

Microbial Air and Surface Monitoring

Air sample every 6 months

Sufrace sample every month

Cleaning and Disinfecting

Use a germicidal agent and sterile water. A sporicidal agent only needs to be used monthly.

Clean all ISO Class 5 surfaces and cleanroom floor daily. Clean walls, doors, ceilings, storage monthly.

• Think “daily surfaces clean daily”. Structure is cleaned monthly.

Disinfect PEC Class 5 at beginning of shift, every 30 minutes or before each lot, after each spill or when surface is contaminated

Personal Protective Equipment (PPE)

Gown, head cover, face mask, facial hair cover, shoe covers (double for hazardous compounding)

Garb Order

1. Shoe covers, head/face covers and masks

2. Wash hands and forearms for 30 seconds w/soap and water

3. Gown

4. Glove (after alcohol-based agent wash).

Routinely disinfect glove with sterile 70% isopropyl alcohol

Quality Assurance Program

MUST include cleaning procedures, how to respond to drug recalls, justification of selected BUD, etc.

Staff Training

• Didactic education every 12 months

• Requalification

  • Category 1 and 2: every 6 months

  • Category 3: every 3 months

• Observation of hand hygiene and garbing

• Media-fill test

• Gloved fingertip and thumb sample

• Surface sample

Sterility and Pyrogens Testing

Batch sterile preparations compounded from non-sterile ingredients must be tested for sterility and pyrogens. Exceptions:

• Self-administered eyedrops for a single patient for 30 DS or less per Rx

• Self-administered inhalation for a single patient for 5 DS or less per Rx

• Topical ophthalmic, inhalation preparations do NOT require pyrogen testing.