Compliance to USP 797- Pharmacy Compounding Consulting

Compliance to USP 797:

Compliance to USP 797 regarding Pharmacy Compounding is always an important issue for all compounding pharmacies to address as quickly as possible. HCC reported to all specialty compounding pharmacies last year that actions proposed by the Michigan legislature may have been just the beginning of things to come. Directly related to the 2012 meningitis outbreak that has been linked to the now defunct New England Compounding Center (NECC), many states now are considering legislation for additional compliance regulations for compounding pharmacies that even include increased criminal penalties for many violations.

To help our clients and anyone involved in a Pharmacy Compounding business, HCC would like to share the following Risk Level Assessment guide that recently was published in the United States Pharmacopoeia—National Formulary (USP-NF) entitled “USP Tests and Assays Chapter 797, Pharmaceutical Compounding, Sterile Preparations.” This deals with new requirements for the compounding, preparation, and labeling of sterile drug preparations and applies to health care institutions, pharmacies, physician practices, and other facilities that prepare or compound sterile preparations.

Pharmacy Compounding–USP <797> Risk Level Assessment
Risk Category Requirements, Guidance & Examples
Immediate-Use
  • For emergent use, or situations where low-risk compounding would add risk due to delays
  • No storage or batch compounding
  • Continuous compounding process lasting less than one hour
  • Aseptic technique utilized
  • Administer less than 1 hour after preparation begins, or discard
  • Simple transfer of sterile nonhazardous drugs or diagnostic radiopharmaceuticals
Low-Risk Level
  • Simple admixtures compounded using closed system transfer methods
  • Prepared in ISO Class 5 LAFW
  • Located in ISO Class 7 buffer area with ISO Class 8 ante area
  • Examples include reconstitution of single-dose vials of antibiotics or other small-volume parenterals, preparation of hydration solutions
Low-Risk Level with <12 Hour Beyond Use Date
  • Simple admixtures compounded using closed system transfer methods
  • Prepared in ISO Class 5 PEC
  • Compounding area is segregated from non-compounding areas
  • Administration must start no later than 12 hours after preparation
Medium-Risk Level
  • Admixtures compounded using multiple additives and/or small volumes
  • Batch preparations (e.g., syringes)
  • Complex manipulations (e.g., TPN)
  • Preparation for use over several days
  • Prepared in ISO Class 5
  • Located in ISO Class 7 buffer area with ISO Class 8 ante area
  • Examples include pooled admixtures, parenteral nutrition  solutions using automated compounders, batch-compounded preparations that do not contain bacteriostatic components
High-Risk Level
  • Non-sterile (bulk powders) ingredients
  • Open system transfers
  • Prepared in ISO Class 5
  • Located in ISO Class 7 buffer area with separate ISO Class 8 ante area
  • Examples include CSPs prepared from bulk, nonsterile components or final containers that are nonsterile and must be terminally sterilized

 

Various studies to date have shown that many compounding pharmacies have been slow to react to the guidelines of US797 regarding compliance. The most often cited reasons include:

– Leadership’s lack of knowledge &/or support
– Financial and budgetary restrictions
– Physical plant limitations
– Lack of available training & competency resources
– Time required to implement changes

If you are a compounding pharmacy, the time to get into compliance is now! Do not let small issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding the requirements to the USP 797 guidelines. Healthcare Consultants has been helping pharmacies since 1989. Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.


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