Table 1.

Standard operating procedure for UCSD research pharmacy repackaging procedures for co‐encapsulated IS‐Rifamate dispensed to patients

Upon arrival of the patient, collect the prescription and follow the procedures below:

1. Make sure the working counter is clutter free.

2. Assemble all the materials needed for repackaging: • Empty opaque white, size 00EL Capsugel capsules • Rifamate 300/150 mg capsules • Proteus Ingestible Sensors (ISs) ‐ use ISs from a sealed bottle or from a partial bottle opened within the same calendar day. Destroy partial bottles the next day. • HDPE bottle • Repackaging worksheet and log • Prescription labels • Polylined Sterile Field • Sterile gloves / hair cover / lab coat (disposal gown and mask‐optional) • Isopropyl alcohol and gauzes • Pill counter tray and spatula

3. Place on hair cover and mask (optional).

4. Wash your hands.

5. Place on lab coat (or disposable gown).

6. Wipe down the repackaging area as well as the pill counter tray and spatula with gauzes saturating with isopropyl alcohol.

7. Remove a disposable Polylined Sterile Field and place it on the dry, clean surface of the counter.

8. Using the pill tray and spatula, count out the appropriate number of empty gelatin capsules, ISs, and Rifamate, and place them on the sterile field in separate piles.

9. Wash your hands again.

10. Place the sterile gloves on and begin to assemble the capsules.

11. Open the empty gelatin capsule.

12. Place the IS in the body of the capsule.

13. Place a Rifamate on top of the IS in the body of the capsule.

14. Close the gelatin capsule with the top until it snaps firmly in place.

15. Once all capsules are completed, visually inspect each capsule to make sure all the components are in place. The IS and Rifamate can be readily identified through the white opaque capsule.

16. There should be no left over components (i.e. Rifamate, ISs, or empty gelatin capsules) once the repackaging is complete. If there are, all capsules will need to be reassembled, inventory evaluated, and procedure repeated.

17. Place the Co‐encapsulated IS‐Rifamate capsules in the HDPE container and close the HDPE container.

18. Dispose of the sterile field and gloves in the trash.

19. Fill out the repackaging worksheet and logs.

20. Place the following labels on the HDPE container: • Prescription label • AVRC lot and exp: date label (35 days from when the IS bottle is open) • Label explaining the storage conditions of the product • Label stating the drug has been repackaged by the UCSD Research Pharmacy.

21. Fill out the drug accountably log.

22. File a copy of the repackaging worksheet in the study log book. File the original in the UCSD Research Pharmacy Repackaging Log Book.

23. Dispense the finished prescription to the patient or study coordinator.