Summary of USP 797 for Compounding Sterile Preparations

States have the choice to implement exactly or to edit the standards into pharmacy regulations. Antineoplastic hazardous drugs. It is important that there is tight control at each step in this pathway, along with safeguards to prevent unintended consequences. The proposed chapter also places a larger emphasis on routine calibrations, dating certifications and qualifications of equipment and classified areas.

  • It also cautions firmly against the use of a pneumatic tube system to transport any liquid hazardous drug and any antineoplastic hazardous drug due to breakage and contamination risks.
  • The United States Pharmacopeial Convention.
  • It is not possible to use a manufacturer's expiration date and extrapolate or estimate a beyond use date for a compounded formulation.
  • The use of a central pharmacy offers a number of advantages over immediate-use compounding in a patient area.

USP Key Considerations and Changes for Health Systems


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  1. Non-antineoplastic hazardous drugs and drugs that pose a reproductive risk.
  2. Expiration dates are required on commercially manufactured products and are determined after extensive study of the product's stability.
  3. Containment requirements guide.

This is an area for future improvement. Many times the published references do not evaluate exactly the same formulation, or the study did not examine the stability for a long enough period of time. The only thing that stays the same is that everything changes. Preparation Characteristics.

USP Key Considerations and Changes for Health Systems

Because of compelling patient-care needs, a pharmacist may be unable to stay within the approved labeling and product guidelines stated in the package insert. In these instances, pharmacists should consult with the drug's manufacturer to establish a beyond use date. When this is not possible, a pharmacist ideally consults with the manufacturer to establish a beyond use date. Beyond use dates should be in accordance with the manufacturer's approved labeling. Pharmacists should obtain a letter from the manufacturer certifying the beyond use dating period provided.

Leaders are looked to for guidance in times of change. American Society for Healthcare Engineering. When a hazardous drug is in transit, it must be clearly labeled so as to be easily identifiable as such, at all times. However, reliable, published stability information is sometimes lacking for many types of drugs. Joining a Pharmacy Organization Yields Benefits.

It is important to make modifications in such a way as to minimize interruptions to ongoing pharmacy operations, as it is important to continue to provide care to patients. If the sterile drug is an antineoplastic that requires manipulation, it must be stored in a negative pressure buffer area anyway. Open in a separate window. Tadalafil is now free of patents, dating free and compounding pharmacies have some opportunities to use this drug in various customized medications. Author information Copyright and License information Disclaimer.

The section on hazardous drugs is aimed at protecting handlers from exposure to certain drugs during preparation. Support Center Support Center. Practices that increase pharmacy presence in patient care areas and decrease time to administration of medications compounded in the pharmacy decrease the need for immediate-use compounding.

This requirement can present challenges, as a dedicated space for unpacking that meets these requirements has to be found. Conduct a gap analysis Prioritize projects according to feasibility, ease of execution, and resource sharing amongst departments. The recommendations in this section provide a broad scope of guidance and do not offer in-depth recommendations on the areas listed above. Additionally, the proposed chapter requires that calibrated chart recorders are used to monitor each cycle for sterilization and depyrogenation in autoclaves and dry heat ovens. Jeff Gloyer is an engineer I with Eagle.

The authors of the study point out that multiple medical personnel were used to draw up syringes, with varying levels of adherence to aseptic technique. Prioritize projects according to feasibility, ease of execution, and resource sharing amongst departments. State boards of pharmacy usually regulate the compounding practices of the organizations within their jurisdiction.

Questions about Multi-dose vials

Beyond Beyond Use Dating Revisions - Pharmacy Inspection

The process by which a hazardous drug is delivered to an institution until that drug is safely administered to a patient consists of many steps. Notify me of new posts by email. Vitamin D Is the New Hormone. These devices are more expensive than traditional needle and syringe compounding equipment. This point should be emphasized with all compounding personnel.


Want to learn more about testing and compliance? Constipation Frustrates Patients and Providers. This is in contrast to incompatibilities that can be visually observed. Form partnerships among departments within the health system Form partnerships among nearby hospitals Consider the possibility of outsourcing. Additionally, not all changes have to be implemented at once.

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Highly particulate generating materials, like lead containers, are required to be used for the protection of handlers. Prepare for change management Maintain staff morale Manage expectations Foster teamwork. It is under review by numerous others. Injection practices among clinicians in United States health care settings. If an organization upholds standards throughout the entire process except for one step, then that entity can be considered noncompliant.

This involves tracking of personnel via assessments and documentation of symptom complaints, physical findings, and laboratory values in order to assess deviations from norms and changes over time. Storage requirements guide. Opened single-dose ampuls must be discarded and may not be stored for any time period.


Pharmacists should serve as champions to educate staff on proper utilization of immediate-use compounding, including the use of single- and multi-dose vials in patient care areas. Of course, waste disposal should be according to state and federal regulations. In other words, the evidence is not from a product-specific experiment. Follow containment requirements per manufacturer or conduct an internal assessment of risk to determine if alternative containment strategies are necessary. Do not require further manipulation other than counting dosage forms.

Challenges Ensuring appropriate beyond use dating and stability of products compounded outside of the pharmacy poses a number of challenges. Hazardous drug exposures in health care. Airflow and balance testing are required at installation site. These standards are important and, when upheld, can mitigate serious patient harm. History of sterile compounding in U.

Outside the Hood

Hazardous drugs that must be stored separately from other nonhazardous drugs. This standard will require many key operational changes for health systems and will have a far-reaching impact for maintaining patient care standards and health care employee safety and protection. Until the standard becomes official, it is important for pharmacists to become familiar with the latest draft, identify potential barriers to compliance, and strategize a plan to overcome barriers.

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