Frequently Asked Questions (FAQs) about USP <797>
Specific Questions about USP <797> – Exemption
Are there exceptions for rural hospitals?
No. USP <797> applies to all places that prepare and dispense sterile drugs. USP <797> requirements apply equally to all settings, including pharmacies, hospitals, clinics, and medical offices. The rationale for this requirement is that sterile drugs must be of appropriate quality, regardless of their location of preparation.
Are nuclear medicine departments "exempt" from complying with USP <797> if they use only unit doses supplied by commercial nuclear pharmacies?
Yes, if they administer only the unit dose. If, however, the unit dose is manipulated (e.g., normal saline is added to the syringe to dilute the contents), then USP <797> standards do apply. Note: nearly all such manipulations can likely fall under the immediate-use exemption.
Are mobile nuclear medicine trucks "exempt" from complying with USP <797> if they use only unit doses supplied by commercial nuclear pharmacies?
Yes, if they administer only the unit dose. If, however, the unit dose is manipulated (e.g., normal saline is added to the syringe to dilute the contents), then USP <797> standards do apply. Note: nearly all such manipulations can likely fall under immediate-use exemption.
Can 99mTc in vitro RBCs (UltraTag™) be prepared under the immediate-use exemption?
Yes, if a special standard operating procedure (SOP) is developed and followed whereby the number of needle puncture entries into the reaction vial is limited to two. Also remember that USP <797> requires that blood manipulations be clearly separated from routine procedures and that they be controlled by specific SOPs to avoid cross contamination.
Is changing a needle on a unit dose syringe exempt from USP <797>?
If a unit dose syringe contains too much activity, can some of the contents be squirted out without invoking USP <797>?
Is adding lidocaine to a unit dose syringe of 99mTc-sulfur colloid for lymphoscintigraphy exempt from USP <797>?
No, this is considered compounding under USP <797>. However, this addition can likely fall under the immediate-use exemption.
If I make a kit of Tc-99m MAA or Tc-99m MDP and inject multiple patients from that vial all within one hour of preparation does this fall within the immediate use category?
USP <797> does not clearly articulate that the immediate use exemption is limited to single doses. Our interpretation of the USP <797> Immediate-Use provision is that it applies to single-dose containers (i.e., products without antimicrobial preservatives, including these radiopharmaceuticals). A kit of Tc-99m MAA or a kit of Tc-99m MDP could be prepared under the immediate use exemption and used for immediate patient injection within 1-hour of preparation, but the remaining contents in the vial must be discarded after that hour.
If I receive a bulk vial of Tc-99m pertechnetate from my USP 797 compliant pharmacy, can I withdraw from that vial multiple times throughout the day as long as what I am compounding is used within one hour?
No. In a non-controlled air quality environment, a kit using Tc-99m withdrawn from the Tc-99m sodium pertechnetate vial could be prepared under the immediate use exemption and used for immediate patient injection within one hour of preparation, but the remaining contents in both the kit vial and the sodium pertechnetate vial must be discarded after that hour. Multiple uses (more than two needle punctures or a second needle puncture beyond one hour of the first) of the Tc-99m sodium pertechnetate vial constitutes low-risk level compounding and therefore must be performed in an ISO Class 5 environment (e.g., laminar flow hood) located in an ISO Class 7 buffer area or segregated compounding area.
If a drug requires a 2-hour infusion, can it be administered under the immediate use rule as long as the dose is drawn up and the infusion started within one hour?
Yes. Under the Immediate-Use provisions, administration must BEGIN within one hour following the START of the preparation of the CSP. Thus, if the infusion is begun within one hour of the start of the preparation, it can be allowed under Immediate Use even though the infusion continues over a longer time. But if the prepared CSP for the infusion has an expiration of less than two hours post preparation, this compounded drug is not suitable for the 2-hour infusion even though it meets the Immediate-Use provisions under USP <797>.
If the only compounding activities performed in a nuclear medicine department involve Immediate-Use products, does the department need to have policies and procedures for aseptic training and daily cleaning?
No. As stated in FAQ # 54 on the USP website (see: http://www.usp.org/audiences/pharmacist/797FAQs.html), immediate use compounding is exempt from all requirements of the chapter. Nonetheless, it would be professionally appropriate to have some very basic training and policies and procedures regarding the criteria for Immediate-Use CSPs, adherence to the 1 hour BUD and aseptic technique, proper hand hygiene, and avoidance of touch contamination.
These FAQs reflect the authors' views only. They have not been provided or endorsed by the USP Convention or the USP Expert Committee on Sterile Compounding, nor do they necessarily reflect the views of the authors' institutions, SNM, or any other entities. This document is provided for informational purposes only and is not intended as legal advice. It should not be used to replace the advice of your own legal counsel.