Controlled access mixing vial

A controlled access mixing vial, for use with first and second pharmaceutical components, the second component being a liquid component, comprising:

• a mixing container having first and second ends with openings at the first and second ends;
• a septum mounted to and sealing the first end of the mixing container;
• a breachable seal at the opening at the second end of the mixing container, the first component being within a mixing region between the seal and the septum;
• a supplemental container;
• the mixing and supplemental containers being coaxially translating containers with the second end of the mixing container sealably positioned within the supplemental container, the second component being within a variable volume region defined by the mixing and supplemental containers;
• a first rotary drive element associated with and covering the first end of the mixing container, the first rotary drive element including a first housing having a central opening opposite the septurn;
• a second rotary drive element associated with the supplemental container;
• thread means for rotationally coupling the first and second rotary drive elements so that rotating the first and second drive elements in a first rotary direction from an initial rotary orientation to a final rotary orientation drives the mixing container into the supplemental container from a pre-mixed condition to a post-mixed condition to force the second component past the breachable seal and into the mixing region causing the first and second components to mix to create a mixed pharmaceutical;
• a first rotary lock operably coupling the first and second rotary drive elements when in the initial rotary orientation and preventing rotary movement except in the first rotary direction when in the initial rotary orientation;
• and
• a second rotary lock operably coupling the first and second drive elements when in the final rotary orientation and preventing any relative rotary movement therebetween when in the final rotary orientation;
• a safety shield mounted to the first housing and covering the central opening;
• means for automatically dislodging the safety shield from covering the central opening upon movement of the mixing and supplemental containers to the post-mixed condition so to provide user access to the portion of the septurn;
• and
• a user-actuated septurn shield movably mounted to the first housing for movement between a septurn-exposed position and a septurn-covered position, the septurn shield including a cut-out which overlies the central opening when in the septurn-exposed position.