Systems and Methods for Compounding Injectable Therapeutic Agents

A method for compounding a therapeutic agent for intravenous administration, comprising:

• providing a vial comprising a puncturable closure and containing the therapeutic agent dissolved in a carrier at a dose or concentration that is therapeutically effective for a particular patient but is not commercially available at the therapeutically effective dose or concentration or is on the U.S. FDA drug shortage list, disinfecting the closure and optionally disinfecting a port comprising a spike and connected to a container containing a diluent, connecting the vial to the port such that the spike punctures the closure, adding the therapeutic agent dissolved in the carrier to the diluent through the port, and verifying that the vial is depleted of the therapeutic agent dissolved in the carrier;
• provided that the therapeutic agent is not dissolved in the carrier by drawing the carrier into a syringe, injecting the carrier from the syringe into the vial containing the agent in powder form and mixing the carrier with the agent to obtain a reconstituted preparation of the agent, removing the reconstituted preparation of the agent from the vial, and combining the reconstituted preparation of the agent with another reconstituted preparation of the agent, provided that no diluent is removed from the container prior to allowing the therapeutic agent dissolved in the carrier to flow into the diluent via the port, and provided that the volume of the agent dissolved in the carrier is less than 10% of the volume of the diluent in the container.

A method for compounding a therapeutic agent for intravenous administration, comprising:

• providing a vial comprising a puncturable closure and containing the therapeutic agent dissolved in a carrier at a dose or concentration that is therapeutically effective for a particular patient but is not commercially available at the therapeutically effective dose or concentration or is on the U.S. FDA drug shortage list, disinfecting the closure and disinfecting a port comprising a spike, connecting the vial to the disinfected port such that the spike punctures the closure, and connecting the port to a container containing a diluent, adding the therapeutic agent dissolved in the carrier to the diluent through the port, and verifying that the vial is depleted of the therapeutic agent dissolved in the carrier;
• provided that the therapeutic agent is not dissolved in the carrier by drawing the carrier into a syringe, injecting the carrier from the syringe into the vial containing the agent in powder form and mixing the carrier with the agent to obtain a reconstituted preparation of the agent, removing the reconstituted preparation of the agent from the vial, and combining the reconstituted preparation of the agent with another reconstituted preparation of the agent, provided that no diluent is removed from the container prior to allowing the therapeutic agent dissolved in the carrier to flow into the diluent via the port, and provided that the volume of the agent dissolved in the carrier is less than 10% of the volume of the diluent in the container.