A. Any manufacturer located outside the Commonwealth who ships prescription drugs into the Commonwealth shall be registered with the Board. The nonresident manufacturer shall renew such registration annually on a date determined by the Board in regulation and shall notify the Board within 30 days of any substantive change in the information previously submitted.
B. The nonresident manufacturer shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located or current registration as a manufacturer or repackager with the federal Food and Drug Administration and shall furnish proof of such upon application and at each renewal.
C. Records of prescription drugs distributed into the Commonwealth shall be maintained in such a manner that they are readily retrievable from records of shipments into other jurisdictions and shall be provided to the Board, its authorized agent, or any agent designated by the Superintendent of the Department of State Police upon request within seven days of receipt of such request.
2016, c. 221.
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