FAQ re USP <797> 
 

The U.S. Pharmacopeia’s Revised General Chapter <797> Pharmaceutical Compounding - Sterile Preparations, which sets practice standards to help ensure that compounded sterile preparations are of high quality, became official on June 1, 2008. Since that time APIC has received many questions regarding this standard. APIC submitted the following questions to the USP<797> Sterile Compounding Expert Committee and prepared this FAQ to assist you in the  interpretation of the standard. 
 

I.  Issue: Time for spiking IV bags (indirectly relates to 1 hour usage)

Question:  "I have a same day surgery department within my hospital for which I have infection control oversight. I have been asking them for the past year to not spike all their IV bags in the morning but have never been able to find any reference material or documentation to support my thoughts on this practice. Do you know of any resources that support this explicitly?"

USP Answer.  No.

Addendum: This question was also posed to the American Society for Healthcare Pharmacists (ASHP) and it was their judgment that good medication practice would not support this practice. The following ASHP Best Practice information and CSP Recommendations were offered:

A. ASHP Policy and ASHP Author Recommendation on Assembling Doses Hours Before Administration 
 

ASHP guidelines on quality assurance for pharmacy prepared sterile products (Best Practices 2008 edition, p. 63) (Official ASHP policy):

RL 1.11: Handling of Sterile Products Outside the Pharmacy. 
 

Pharmacists should participate in developing procedures for the safe use (e.g., stability, sterility) of sterile products once they are distributed outside the pharmacy. How the product is transported from the pharmacy, how it is stored outside the pharmacy, and methods for return, recycling, and disposal should be addressed in written policies and procedures. (15, 83) Sterile products should be transported so as to be protected from extremes of temperature outside their range of stability and from light if they are photosensitive. Storage containers and packaging verified as suitable for protection during transport should be specified. Transit time and conditions should also be specified and controlled. Delivery personnel should be instructed on special handling procedures. Once delivered to the end user, sterile products should be appropriately stored before use. Pharmacists should ascertain that the user has appropriate locations and equipment for storage (e.g., a refrigerator with a suitable thermometer). Special instructions for storage should be a part of the label or a separate information sheet (e.g., instructions for cleanliness, proper storage, interpretation of the expiration date and how to look for signs of product deterioration). The pharmacist should be notified if storage conditions do not remain suitable so that the pharmacist can give advice as to the disposition of the sterile products and remedies for storage problems. Pharmacists should participate in training end users on the proper care and storage of sterile products, either directly or through written instructional materials.

American Society of Health-System Pharmacists. ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products. Am J Health-Syst Pharm. 2000; 57:1150–69. 
 

B. Compounding Sterile Preparations, 2nd ed, Buchanan and Schneider (p. 122) (Recommendation from authors in book published by ASHP): 
 

Compounded sterile preparations should be issued in limited quantities and organized in the refrigerators so that nursing staff avoid the practice of assembling multiple doses for patient hours before scheduled medication administration. 
 
 

II Issue: 1 hour use-time

Question in 3 parts:  
 

(a)"Is it correct and consistent with current USP-797 that a single dose product, e.g., manufacturer supplied normal saline flush syringe, Versed, Fentanyl, etc., is only good for 1 hour when opened outside of an ISO Class 5 environment?"

USP Answer:  No. 
 

(b) "Is my rendered “opinion” below in conflict with USP-797 and any suggestions on how to address if challenged?" 
 

In our NICU a syringe containing NS flush is attached to a microbore tubing and loaded into a syringe pump.  Because of this population, only a small portion of the contents are infused, for example, prior to giving an IV med, and then soon thereafter.  Practice is that the syringe remains connected to the IV access system or is capped off for subsequent doses of meds as needed.  Historically, our IC system position was that unpreserved meds can be used for up to 24 hours.  For the situation described, I opined that the syringe is in the active phase of intermittent administration and I feel it’s acceptable to use up to 24 hours (the tubing and syringe are labeled and dated so personnel know how long it can be in active use).  Alternatively, if there is no interpretive allowance with USP-797, am I correct that in the situation above the syringe would have to be discarded at 1 hour period? 
 

USP Answer: Yes. Once the syringe has been filled, the extension set attached and loaded into the syringe pump, your use throughout the day is acceptable.  From the perspective of USP Chapter <797> there is no further compounding or manipulation of the syringe itself (or its contents). 
 

(c) "Parallel situation: Many OR/Cath lab procedures progress far beyond 1 hour.  It is common practice for Anesthesia to draw up Versed, Fentanyl, and other products for a procedure on a patient that extends beyond one hour.  If this is the case, do you think we can use the drawn up medications on that patient for as long as needed-or do we need to “time out” at 1 hour point and obtain new medications?  Obviously, they could only be used on the patients for which they were intended (e.g., not the next case), but should they be discarded after an hour? We feel one should finish the case with what it is started--for analgesics I suspect there would be additional headaches with a controlled substance if one had an ample amount of drug left and then had to waste it and then get new drug." 
 

USP Answer: Because of other issues (i.e. controlled substances record keeping, wastage, etc.) described in the above scenario, it would be appropriate to keep that dose and use anytime during the procedure.  What might be suggested is that if for some reason, the dose or syringe is not used during the procedure, the syringe is sent for sterility sampling (per USP <71>).  Routine sampling and testing could be used to establish a longer beyond-use-date (BUD) that works for the organization.