Do the Right Thing: Best Practices for Sterile Compounding

Do the Right Thing: Best Practices for Sterile Compounding

i-syringeDoes your compounding pharmacy take adequate steps to ensure your sterile preparations are safe and effective? A recent survey of FDA issued 483 warning letters found many compounding pharmacies are being cited for inadequate facilities and procedures relating to their sterile preparations. Reputable compounding pharmacies never have these issues and is the reason why it is important to ensure the safe and accurate preparation of your prescription.

After the unfortunate and preventable 2012 outbreak of fungal meningitis related to NECC (New England Compounding Center) in Massachusetts, the US public became aware the role of compounding pharmacies and the lapses in regulatory oversight. Not surprisingly, the FDA responded punitively, to news that 64 people had died and hundreds more had been sickened due to the lax practices at the NECC facility. Fourteen people were arrested with connections to this pharmacy. Two company executives face murder and racketeering charges in several states. All of this could have been prevented by following proper procedures with adequate safety controls.

Since the NECC incident in 2012, the FDA has issued numerous warning letters to compounding pharmacies for serious deficiencies relating to sanitary and safety problems. About two-thirds of these were related to sterility issues, many of which led to drug recalls along with the subsequent loss of revenue and reputation. After the NECC incident, scrutiny for sterile operations at compounding pharmacies has sharply increased.

Navigating the Regulatory Guidance Documents

In the wake of the NECC related deaths and apparent deficiencies in regulatory oversight the FDA has enacted regulation that would close these gaps in oversight. Implementation of the regulations under Drug Quality and Safety Act (DQSA) clarified the FDA’s authority to oversee compounding pharmacies. In the last year, a trio of guidance documents has been released relating to compound pharmacies. Specifically, the guidance entitled “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act” provides current thinking on how to approach sterile preparations. The guidance calls out USP chapter <797> for sterile compounding which is referenced in the pharmacy compounding chapter <795>. The FDA is also working with state regulatory bodies to report adverse events related to sterile compounding and better tracking for issues related to sterile compounding. Knowing and understanding the content of these documents is particularly important for new compounding pharmacies intending to prepare compounded sterile preparations or CSPs.

Implementing USP <797>

USP <797> provides basic guidelines for compound sterile preparations (CSPs). The complexity of facility setup, airflow and procedures requires in-depth knowledge often best dealt with by employing a reputable consultant. Clean room procedures, cleaning and decontamination procedures, airflow must all be validated and regularly monitored and documented. Re-certifications need to occur on a regularly scheduled basis. Responsibilities of compounding personnel are spelled out in this guidance. The required SOPs and suggested documentation are described as well.

To evaluate how well a new compounding pharmacy is complying and accurately interpreting USP <797> it is best to perform a gap analysis to determine deficiencies. There are consultants who will work with you to find areas that need to be improved so that your pharmacy does not receive a 483 warning letter. Often it is best to get an outside observer who can see the errors your personnel have become blind to. As a starting point, there are helpful checklists available online to guide you step by step through the process of evaluating your facility and procedures.

Best Practices for Sterile Compounding

Another helpful document in interpreting USP <797> can be found at the website. Following these guidelines will help a new facility gain the required accreditation and set up processes and procedures to ensure safe and accurate preparation of CSPs. Below are a few highlights from this document.

  • All sterile processes must be validated. Facilities, equipment, cleaning, storage, along with analytical methods must all be validated.
  • Facilities must re-certified on a regularly scheduled basis by certified professionals.
  • All aspects of cleaning and disinfecting procedures must be validated and include challenge tests to verify effectiveness of these procedures.
  • Use qualified, reputable vendors to provide bulk reagents. Using a reliable provider like PNA will ensure safe source materials for your compounds.
  • Expiration and beyond-use dating must be verified and tested. Determining the risk of compounds made from sterile and non-sterile ingredients needs to be evaluated and BUD determined based on intended storage conditions.
  • Personnel involved in sterile compounding must be trained and qualified in all aspects of sterile preparation from hygiene and garbing to procedures performed in clean areas.
  • Packaging and labeling procedures must be well documented and adhere to the regulatory requirements that may include specific state requirements not mentioned in USP <797>.
  • Personnel competency needs to be assessed for a variety of procedures listed in this document. Verifying and documenting your staff can perform procedures relevant to the work you intend to perform is a regulatory requirement and ensures your staff know what they are doing.
  • SOPs documenting all aspects of your facility and procedures need to be accurate and up to date.
  • A solid quality assurance program needs to be in place to your personnel training and assessments, environmental monitoring and equipment calibration and maintenance. Consult USP <797> and state requirements to ensure all aspects of your processes are covered.

This is a very small list of what is required for a compounding pharmacy intending to prepare compounded sterile preparations (CSPs). Following the regulatory guidelines and consultant recommendations will help new lab attain accreditation and to operate safely. Having adequate, well-documented procedures and practices using validated methods will help ensure your pharmacy provides safe sterile product for the patients who need it.

Along with proper setup of your facility, you’ll need the best ingredients for your compounded preparations. Pharmaceutica North America would like to be the supplier of high-quality products for your pharmaceutical compounding needs. Our staff is well-trained and prepared to provide our clients with high-quality ingredients for all their pharmaceutical compounding needs. Contact us today and speak with our knowledgeable customer service to learn more.


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