Pressure-regulating vial access devices and methods

An apparatus for accessing contents of a medicinal container, the apparatus comprising:

• a fluid exchange connector comprising a flange to aid in coupling the apparatus with an exchange device or instrument used in extracting fluid from or injecting fluid into the medicinal container;
• a housing comprising an engagement assembly configured to be coupled to the medicinal container, wherein the engagement assembly comprises at least one of a cap connector, an adhesive, or tape;
• an insertion assembly comprising:
• a piercing member having an extractor aperture;
• an insertion member comprising the piercing member at a distal end of the insertion member;
• an insertion member channel having a proximal end;
• and
• a locking ring configured to engage with a protrusion at the proximal end of the insertion member channel,
• wherein the insertion member is configured to slide along the insertion member channel, and the piercing member is configured to pierce a septum of the medicinal container;
• an extractor channel configured to connect the extractor aperture to the fluid connector;
• and
• a regulator channel configured to regulate pressure within the medicinal container while extracting fluid from or injecting fluid into the medical container;
• wherein the engagement assembly is configured to prevent the insertion member from sliding along the insertion member channel until the apparatus is coupled to the medicinal container;
• wherein the engagement assembly engages the locking ring when the insertion member is moved into a fully inserted position;
• and
• wherein the engagement assembly is configured to prevent the piercing member from piercing the septum of the medicinal container until the apparatus is coupled to the medicinal container.