Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.006 - Requirements for Records, Inventories, and Reports

Current through Register 1525, July 5, 2024
(A)
Records Required,
			 Generally
. Every person registered with the Commissioner shall
			 keep records, maintain inventories, and make reports in conformance with the
			 requirements of the Federal
Comprehensive Drug Prevention and Control
			 Act of 1970
and the Federal Food, Drug and Cosmetic Act, and
			 105
			 CMR 700.006.
(B)
Time for Keeping
			 Records
. A registrant shall keep for at least two years from the
			 date of preparation, every report, inventory and record they are required to
			 keep by
			 105 CMR
			 700.000.
(C)
Central Record
			 Keeping
. Any registrant may keep central records if they hold a
			 valid permit to keep central records issued by the DEA and notifies the
			 Commissioner thereof. The registrant must keep records in a manner that makes
			 them easily available for inspection upon request of the
			 Commissioner.
(D)
Exemptions from Record Keeping
. A registered
			 practitioner who uses any controlled substance in research or teaching at a
			 registered health care facility or health care entity which maintains records,
			 is exempt from the requirement to keep their own records, if they have notified
			 the DEA and the Commissioner of the name, address and registration number of
			 the institution registered by the DEA, which maintains their records; and a
			 registered chemical analyst employed by a analytical laboratory which maintains
			 records, is exempt from the requirement to keep their own records if they have
			 notified the Commissioner of the name, address and registration number of the
			 analytical laboratory which maintains their records.
(E)
Inventory
			 Requirements
. Every registrant shall take an initial inventory and
			 biennial inventories thereafter.
(1) Every
			 registrant required to take inventories under federal law and regulations shall
			 follow those requirements, which are deemed to include Schedules I, II, III,
			 IV, and V only.
(2) Every
			 registrant shall take an initial inventory of all their controlled substances
			 in Schedules II through V on the day they first engage in the manufacture,
			 distribution, or dispensing of controlled substances.
(3) Every registrant shall take a new
			 inventory of all stocks of controlled substances in Schedules II through V
			 every two years following the date on which either the Federal or State initial
			 inventory was taken, as applicable:
(a) On the
			 day of the year on which the initial inventory was taken;
(b) On the registrant's regular physical
			 inventory date, if any, which is nearest to and does not vary by more than six
			 months from the biennial date and which would otherwise apply; or
(c) Any other fixed date which does not vary
			 by more than six months from the biennial date which would otherwise
			 apply.
(4) A registrant
			 who elects to take their biennial inventory on their regular general physical
			 inventory date or another fixed date, shall inform the Commissioner of this
			 election and of the date on which they will take his biennial inventory upon
			 request.
(5) Whenever the
			 Commissioner by regulation adds to any schedule a controlled substance which
			 was not immediately prior to that date listed in a schedule on which a
			 registrant was required to keep records, a registrant who possesses that
			 substance shall:
(a) Take, on the effective
			 date of the regulation, an inventory of all stocks of that substance on hand
			 and;
(b) Thereafter, include such
			 substance in each inventory made by such registrant.