Responding to shortages of certain medications to treat COVID-19 patients, the U.S. Food and Drug Administration (FDA) outlined rules, allowing healthcare to use products beyond their “in-use time,” states an FDA press release. The “in-use time” is the maximum amount of time allowed before administering a sterile drug product after penetrating its container-closure system or a lyophilized drug product after it has been reconstituted.
The FDA said healthcare facilities should not use these products more than four hours beyond their “in-use time” if in refrigerated storage or more than two hours beyond their “in-use time” if in room-temperature storage. The guidance applies to 10 products:
· Cisatracurium besylate EQ 2 mg base/mL, EQ 10 mg base/mL
· Phenylephrine hydrochloride 0.1 mg/mL, 10 mg/mL (10 mg/mL), 50mg/5mL (10 mg/mL), 100 mg/10mL (10 mg/mL)
· Bumetanide 0.25 mg/mL
· Midazolam hydrochloride EQ 1 mg base/mL, EQ 5 mg base/mL
· Succinylcholine chloride 20 mg/mL
· Famotidine 10 mg/mL
· Hydromorphone 0.2 mg/mL, 1 mg/mL, 2 mg/mL, 4 mg/mL, 10 mg/mL
· Rocuronium bromide 50 mg/5 mL (10 mg/mL), 100 mg/10mL (10 mg/mL)
· Epinephrine EQ 1mg base/mL (EQ 1 mg base/mL) and EQ 30 mg base/mL (EQ 1 mg base/mL)
· Heparin sodium 1,000 units/mL, 5,000 units/mL, 10,000 units/mL (NDCs: 0069-0058-01, 0069-0059-01, 0069-0059-03, 0069-0137-03, 0069-0043-01)
• When an injectable drug product is prepared for administration per labeling instructions, and where FDA-approved labeling describes an in-use time for that drug product, the Agency has not necessarily evaluated data to support a longer in-use time. Use of these drug products beyond the labeled in-use times can raise important concerns related to product safety.
• Therefore, the agency is providing the following information to minimize the likelihood of physicochemical degradation or microbial proliferation during use in situations where a provider is considering use beyond the labeled in-use time for the above-listed products. If there is a need to use these products beyond the labeled in-use time to help ensure access to the drug for patients, it is important that this period be as short as possible, and for a maximum of:
o four (4) hours for a refrigerated storage condition (if any), or
o two (2) hours for any labeled room temperature in-use time (if any)
for the specific drugs listed above.
This extended use applies to either the refrigerated or the room temperature in-use storage condition and not both storage conditions even if both refrigerated and room temperature in-use lifetimes are provided in the labeling.
Information for Drug Manufacturers:
• Application holders who wish to extend the in-use time described in their FDA-approved drug labeling should submit a supplement to their application(s). Questions about the appropriate supplement type or data to be included may be sent to [email protected].
