Current through Register 1533, October 25, 2024
Section 700.007 - Inspection of Premises(A)Inspections and Investigations. The Department may visit the registered site of a registrant at any time without prior notice and inspect it, its staff, activities and records to determine compliance with state law, 105 CMR 700.000, 105 CMR 721.000: Standards for Prescription Format and Security in Massachusetts and 105 CMR 722.000: Dispensing Procedures for Pharmacists upon stating his or her purpose, and presenting his or her appropriate credentials.(B)Statement of Deficiencies. After every inspection conducted pursuant to 105 CMR 700.007(A) in which any violation of law or regulation is observed, the Department shall prepare a deficiency statement citing every violation observed, a copy of which shall be sent to the registrant.(C)Plans of Correction. A registrant shall submit to the Department a written plan of correction of each violation cited in a deficiency statement prepared pursuant to 105 CMR 700.007(B) within 30 business days after the deficiency statement is sent. Every plan of correction shall set forth, with respect to each deficiency, the specific corrective step(s) to be taken, a timetable for such steps, and the date by which compliance with the relevant section of law or regulation will be achieved. The timetable and compliance dates shall be consistent with achievement of compliance in the most expeditious manner possible. A plan of correction which does not meet the requirements of the relevant section of law or regulation shall be considered unacceptable by the Department and returned to the registrant.(D)Investigations of Drug Incidents and Complaints. When the Department is investigating a possible drug diversion or tampering matter, or a drug related complaint, registrants shall provide the Department with timely access to potential witnesses and records, including, but not limited to, controlled substance, medical, employee and security records. Access to documents may be provided by production of copies of the relevant records to the Department, unless the Department requests access to the original record.(E)Interference with Investigations. Whoever hinders, obstructs or in any way interferes with a Department inspector in the performance of such inspector's official duty, shall, for the first offense be punished by a fine of not more than $50.00 for each day the violation continues. Each subsequent offense may be punished by a fine of not more than $100.00 for each day the violation continues.Amended by Mass Register Issue 1338, eff. 5/5/2017.Amended by Mass Register Issue 1377, eff. 11/2/2018.Amended by Mass Register Issue 1488, eff. 2/3/2023.