Storage area can be locked. Investigational drug is stored separately from other compounds. Non-dispensed drug is stored separately from returned dispensed drug. Inventory control procedures are used. Any environmental controls are maintained.
Access is limited to study staff.
According to the Minnesota Statutes and Rules, only a licensed practitioner or pharmacist is authorized to compound or dispense legend drugs. This applies to legend drugs used in a research project and to those drugs not yet approved by the Food and Drug Administration. A physician assistant or advanced practice registered nurse must have a written agreement with a physician defining the scope of the delegated responsibilities related to the prescription, dispensing and administration of drugs. The label or labeling of an investigational new drug shall not bear any statement that is false or misleading in any particular and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated. In the case of combining premanufactured drug products, the manufactured drug products, the names of the products, or a category of use name shall suffice.