Video summary

USP 795 Updates: New Non-Sterile Compounding Standards

Main summary

Key takeaways

Educational

Main ideas, concepts, and lessons conveyed

Purpose and scope of USP <795>

  • USP <795> sets standards for non-sterile compounded preparations (CNSPs) for human and animal use.
  • The goal is to compound the safest CNSPs by reducing risk of:
    • Excessive microbial contamination
    • Incorrect ingredients
    • Products being outside 10% of intended strength
    • Physical/chemical incompatibilities and contaminants
    • Use of appropriate quality ingredients
  • Where it applies (compounding):
    • When pharmacists/technicians mix drugs and ingredients to create what is dispensed.
    • Applies to multiple dosage form routes, including oral, rectal, vaginal, topical, nasal, and otic.
  • Where it does not apply (repackaging):
    • Repackaging is outside USP <795> when the chemical composition is not altered, such as:
      • Unit-dose packaging (e.g., bubble packing)
      • Splitting tablets
      • Reconstituting per manufacturer label
      • Preparing a single dose for a single patient to be used within 4 hours (e.g., opening a capsule, crushing a tablet)
  • Regulatory/implementation touchpoints mentioned:
    • Included in federal law via FDA under FD&C Act §503A (patient-specific compounding).
    • Surveyable by Joint Commission and other accrediting agencies.
    • Wisconsin incorporation: USP <795> into Wisconsin FAR 15 in 2025 (speaker corrects a typo earlier saying 2026).

October 2024 update—learning objectives

After the session, learners should be able to:

  • Identify new requirements in the October 2024 update of USP <795>.
  • Explain challenges, strategies, and tips for implementing standards in:
    • Hospital pharmacies
    • Community pharmacies

Detailed requirements and implementation guidance (as presented)

1) Compounding facility design and workflow controls

  • Create a designated area for non-sterile compounding where no other activities occur at the time of compounding.
  • Ensure enough space to arrange components in an orderly fashion to prevent mix-ups.
  • Use surfaces that are easily cleaned (no fabric/carpet).
  • Include a storage area that is:
    • Off the floor
    • Temperature monitored
  • Include a sink with hot/cold water.
    • Strongly recommended: reverse osmosis (RO) water hookup for rinsing.
  • Include an area to perform compounding itself.

2) Closed system processing devices (controlling airborne particles)

USP <795> discusses using closed system processing devices to protect employees from airborne particles.

  • Examples (from simplest to most complex):
    • Single-use containment bag
      • Used for powder/particle containment during crushing (bag traps vapors/airborne powder).
    • CVE / “powder hood” (containment ventilated enclosure)
      • Uses airflow to move airborne contaminants away from the compounder.
    • Biological safety cabinet (externally vented)
      • Uses airflow to direct particles away from the compounder.
  • If you choose not to use a device, you must evaluate/document the rationale for surveyor review.
  • Equipment certification reports should be saved for surveyors.

3) Cleaning and sanitation requirements (with frequency)

  • Surfaces/equipment must be cleaned with:
    • a cleaning agent followed by a sanitizing agent, OR
    • a combined cleaning/sanitizing agent (example mentioned: “Preempt”)
  • Equipment/utensils:
    • Clean with cleaning agent (e.g., soap/water)
    • Perform a final rinse with purified water
    • RO water is emphasized to reduce excessive use of sterile water for rinsing.

Cleaning frequency (conceptual comparison to USP <797>):

  • Work surfaces: clean at the start and end of each shift
  • Equipment: clean at start of shift and between different CNSPs
  • Storage shelves: clean every 3 months
  • Floors: clean daily
  • Walls/ceilings: clean only if there is known or suspected contamination

Rationale stated:

  • Non-sterile compounding generates more particles, so work surface cleaning is more frequent.

4) Garbing and hand hygiene

  • Remove personal outer garments and items:
    • jewelry, headphones/earbuds, etc.
  • White coat can remain.
  • Wash hands with soap and water for 30 seconds, then dry completely.
  • Put on clean non-sterile gloves.
  • Change or wipe gloves between preparations using different ingredients.
  • Replace gloves if damaged or soiled.

5) Training/competencies and documentation systems

  • USP <795> requires annual staff competencies.
  • USP <795> requires use of:
    • Master Formulation Records (MFRs)
    • Compounding Records (CRs)

Definitions:

  • MFR: the “recipe”/instructions compounding personnel follow for a product.
  • Compounding Record: documentation of everything done for a specific compounded product.

Key MFR emphasis:

  • Include a reference supporting the assigned Beyond Use Date (BUD).

Key CR documentation emphasis:

  • Document every relevant lot/expiration date and the people involved in:
    • compounding
    • checking
  • Provide a reference showing which MFR was used.

Beyond Use Dates (BUDs): how to determine them

  • BUDs depend on maintaining chemical and physical stability while limiting excessive microbial growth.
  • Stability data may require a shorter BUD than USP <795> maximums.
  • USP <795> assumes storage in tight, light-resistant containers when using listed BUD maximums.
  • Consider product classification:

A) Aqueous vs. non-aqueous (water activity)

  • USP uses water activity (a_w):
    • If water activity ≥ 0.6 → aqueous
    • If lower → non-aqueous
  • A table exists (not reproduced fully in the transcript) to determine classification.

B) Preserved vs. non-preserved

  • If ≥ 50% of the base is preserved, the entire product is considered preserved.
  • Example given: crushing tablets and placing into a preserved vehicle (“Ora Plus”) means the product is treated as preserved.

C) Oral vs. topical (different microbial limits)

  • The speaker indicated oral products have lower microbial limits than topical, which affects the applicable maximum BUD.

Maximum BUDs mentioned (summary values)

  • Non-preserved aqueous: 14 days, refrigerated
  • Preserved aqueous: 35 days, room temperature allowed
  • Oral non-aqueous: 90 days, room temperature or refrigerated
  • Topical non-aqueous: 180 days, room temperature or refrigerated

Extending BUDs beyond USP maximums

You may extend beyond maximums only if:

  • a USP monograph supports it, or
  • a stability study includes antimicrobial effectiveness data

Reinforced learning point: USP monograph can extend BUDs; stability study alone is not sufficient without antimicrobial effectiveness data.

Special case: open containers of commercial ingredients

  • For unopened/opened commercial ingredients:
    • USP <795> allows using opened containers until the manufacturer expiration date.
  • Exception:
    • If manufacturer labeling requires a shorter time after opening (example mentioned: lorazepam oral concentrate).
  • Example noted: extends even to sterile water for irrigation and non-preserved products when no manufacturer exception exists.

Hazardous drug intersection (USP <800> + USP <795>)

  • Hazardous non-sterile compounding overlaps with USP <800>.
  • NYOSH categories mentioned:
    • Table 1: known carcinogens
    • Table 2: possible carcinogens and/or reproductive toxins
  • Compounding expectations described:
    • Table 1 antineoplastics must follow all USP <800> precautions
    • Table 1 non-antineoplastics and Table 2 drugs may be risk assessed to possibly reduce some USP <800> requirements

Hazardous drug cleaning sequence (explicitly described)

  1. Use a deactivating agent (renders hazardous drug inert)
  2. Use a decontamination agent (removes hazardous drug residue)
  3. Then use normal cleaning (e.g., soap and water)

Hospital implementation examples (Children’s Wisconsin) — strategies and practical tactics

Closed system device selection based on frequency

  • Choose device based on how often powder-generating activities occur:
    • Rarely crushing tablets → containment bag may be enough
    • Frequently crushing daily → powder hood more suitable
    • Crushing hazardous drugs → biological safety cabinet in a negative pressure room
  • Document equipment evaluation if not using devices.

Competency management

  • Use train-the-trainer approach to avoid overwhelming staffing schedules.
  • Use electronic learning modules and videos to teach technique.
  • Use software tracking (or Excel) for:
    • completion dates
    • next due dates

Cleaning documentation workflow

  • Combine:
    • electronic tracking
    • physical reminders such as a whiteboard listing required cleaning tasks
  • Record last cleaning date/time on the board to prompt correct prep before compounding.
  • Store cleaning supplies near the work area to encourage compliance.

Templates and recordkeeping improvements

  • Create templates for MFRs to ensure all required elements are consistently included.
  • Store documents electronically for ease of access.
  • Fill literature gaps by dividing work (e.g., alphabetically among students/residents), with a final compliance review.
  • Use tech advantages for compounding records:
    • barcode scanning to prevent product mix-ups
    • electronic records to ensure all required info appears in recordkeeping and labeling.

Hazardous non-sterile compounding layout and workflow

  • Separate hazardous and non-hazardous supplies/equipment via:
    • designated areas
    • clear labeling
  • Example workflow:
    • technician prepares hazardous oral liquids in hazardous area
    • a card/workflow cue is given to pharmacist to reduce transfer steps (reduce spill opportunities)
  • Risk assessment template approach:
    • evaluate NYOSH category
    • evaluate who manipulates
    • evaluate manipulation types
    • evaluate possible routes of exposure
    • perform literature review to estimate exposure risk/dose likelihood
    • determine PPE/engineering controls
    • emphasize using a “gut check” to ensure staff safety is not underprotected.

Community implementation considerations (Michelle Ferrell) — “what/where/who/resources/why”

Community pharmacists are encouraged to think in terms of:

  • What must be done
  • Who will do it
  • Where it will be done
  • Why (patient safety/quality)
  • What resources are available

Compliance focus beyond “formulas”

Verify:

  • whether there is an actual formula/standard (not “magic mouthwash” without documentation)
  • consistent processes
  • trained personnel
  • quality ingredients and component maintenance through receiving → reviewing → storage

Example community pharmacy practices (as described)

  • Convert an appropriate area into the primary compounding area (space and workflow control).
  • Identify designated compounding/supervisory personnel for tasks like:
    • compounding
    • supervising cleaning
    • receiving and storing components
  • Document processes:
    • store templates in a pharmacy management system (PMS)
    • store formulas on Google Drive for sharing/review
    • use Google Drive Forms for cleaning documentation
  • Leverage PMS capabilities:
    • build/copy/modify MFRs
    • document who modified
    • link documents to compounding records
    • substantiate BUDs
    • use ingredient barcode verification + lot/expiration tracking
    • provide patient compounded summary sheets
    • ensure adequate pharmacy system support/tech support
    • confirm how the scale integrates (if applicable).

Flavoring exception discussed for community pharmacies (Wisconsin FAR15 reference)

  • Community pharmacists may encounter more frequent “flavoring” additions.
  • A rule/exception described includes:
    • flavoring must be ≤ 5% of the product total volume
    • pharmacist must label the flavoring prescription with a BUD no longer than 14 days if stored in a refrigerator
    • pharmacist must document the addition of flavoring in the record
    • documentation should include details like:
      • type of flavoring agent
      • manufacturer
      • lot number
      • expiration date
  • Mentioned as incorporated by reference into USP <800> and USP <825>.

Learning assessment questions (answers reinforced)

  1. BUD determination: considered factors include water activity, preservatives, and oral/topical use
    • Correct answer indicated: D (all of the above).
  2. Work surface cleaning frequency:
    • Correct answer indicated: C (start and end of each shift when compounding occurs).
  3. Extending BUDs beyond USP maximums:
    • Correct answer indicated: B (USP monograph)
    • Stability study alone is insufficient without antimicrobial effectiveness data.
  4. Wisconsin FAR15 exception for flavoring (timed question):
    • Options included ensuring ≤ 5% flavoring volume, labeling BUD ≤ 14 days refrigerated, and documenting addition (including required detail).
    • The transcript cuts off the exact final statement of the selected option, but the “all of the above”-type content is implied as correct.

Speakers / sources featured (identified in the transcript)

Speakers

  • Megan Oce (session host)
  • Michelle Ferrell (presenter; described as lead luminary of CPESN Wisconsin; past PSW president; owner of Bosabel Pharmacy and Center Pharmacy in Wisconsin’s Driftless region)
  • Holly Sheldon (presenter; described as pharmacy compliance coordinator at Children’s; focus on regulatory compliance and opioid stewardship)

Sources/Standards/Entities referenced

  • USP <795> (and October 2024 update)
  • USP <797>
  • Wisconsin FAR 15
  • FDA via FD&C Act §503A
  • Joint Commission and other accrediting agencies
  • USP <800>
  • USP <825>
  • NYOSH (drug categorization “Table 1” and “Table 2”)
  • USP monographs (basis to extend BUD)
  • Medisca (example of manufacturer providing stability + antimicrobial effectiveness study data)
  • Children’s Wisconsin
  • CPESN Wisconsin
  • PSW (Pharmacy Society of Wisconsin)

Original video