Current through Register 1518, March 29, 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.
(F)
Additional Records
and Inventories Required of Practitioners. All practitioners and
pharmacists shall maintain records and inventories in accordance with
105 CMR
700.000, for each location where they are registered
to receive or store controlled substances. Such records must be kept regarding,
all controlled substances in Schedules II through V which they dispense or
administer in any manner, any exemptions for individual practitioners in
Federal law and regulations notwithstanding. Such records must be accessible at
the location reflected in the records.
(1) All
practitioners shall include in their inventories of controlled substances that
they dispense or administer in any manner, in Schedules II through V, the
following information:
(a) For each controlled
substance in finished form:
1. The name of the
substance; and
2. The size of each
finished form in metric weight or volume; and
3. The number of units or volume of each
finished form.
(b) For
each controlled substance not in finished form:
1. The name of the substance; and
2. The total quantity of the substance to the
nearest metric unit of weight.
(2) Records maintained by practitioners and
pharmacists shall be closed to the public, and shall not be used in the
criminal prosecution of any person in connection with their treatment as a
patient by such practitioner or pharmacist nor shall they be admissible in
evidence against any such patient in connection with such treatment in any
criminal, civil, legislative or administrative proceeding.
(3)
Records for Schedules II
through V. A practitioner and pharmacist shall maintain on a
current basis, separately for each registration they possess, a complete and
accurate record of each substance in Schedules II through V received,
distributed, administered, dispensed, and otherwise disposed of as follows:
(a) The name of the substance and the form of
the substance; and
(b) The size of
each finished form in metric weight or volume; and
(c) The number of units or volume of each
finished form received from other persons; the date received; and the name,
address, and DEA registration number of the person from whom the substance was
received; and
(d) The name, dosage
and strength per dosage unit of each controlled substance administered or
dispensed; the name and address of the person for whom the controlled substance
was administered or dispensed and whether administered or dispensed by delivery
or dispensed by prescription; the date of the administration or dispensing, and
the written or typewritten name or initials of the person who administered or
dispensed the substance; and
(e)
The number of units or volume of such finished forms disposed of in any other
way by the registrant, including the date and manner of disposal.
(4)
Records for
Schedule VI. A registered practitioner who dispenses, other than
by prescribing and administering, Schedule VI sample medications shall maintain
a record, which may be kept in the patient's medical record, of the following
information:
(a) the name, dosage and strength
of the substance dispensed;
(b) the
volume of units dispensed;
(c) the
date of the dispensing; and
(d) the
name and address of the person to whom the medication was dispensed.
(G)
Additional Reporting Required by Manufacturers. Each
registered manufacturer must make available to the Commissioner upon request
the reports accounting for all controlled substances appearing in Schedules I,
II, and III required by federal law and regulations.
(H)
Disposition upon
Discontinuance of Business or Professional Practice.
(1) Any registrant who desires to cease legal
existence or discontinues business or professional practice or moves their
principal place of business or professional practice from the Commonwealth
shall notify the Commissioner in writing at least 30 days before such
event.
(2) Any registrant whose
registration terminates pursuant to
105
CMR 700.004(J), or is voided
pursuant to
105
CMR 700.120, shall inform the Commissioner
how the registrant proposes to dispose of all the controlled substances in the
registrant's possession associated with the discontinued professional practice.
(a) For registrations terminating pursuant to
105
CMR 700.004(I), such
disposition plan must accompany the notice required under
105
CMR 700.006(H)(1).
(b) For registrations suspended, voided or
revoked pursuant to
105
CMR 700.110,
105
CMR 700.115, or
105
CMR 700.120, such disposition plan must be
filed with the Department within ten days of the mailing of the Department's
notice regarding voiding or revocation of the registration. If the Commissioner
does not notify the registrant by the date the registrant has proposed to
dispose of such substances that they should postpone or cancel such disposal,
they may proceed as they proposed to the Commissioner.
(c) Any registrant whose registration has
expired, the executor of the estate of any deceased person in possession of
controlled substances, any registrant in possession of controlled substances
which are safeguarded for or intended to be dispensed to any patient who has
died, or been transferred from the jurisdiction of the registrant without such
controlled substances being transferred, and any other person in possession of
controlled substances for which they are not registered shall dispose of all
controlled substances in their possession through one or more of the following
methods:
1. Under the authorization and
instructions of the Regional Director of the DEA by transfer to a person
registered to possess the controlled substances; or
2. By delivery to an agent of the DEA;
or
3. By delivery to an expressly
authorized agent of the Commissioner; or
4. By destruction of the substances in the
presence of an agent of the DEA; or
5. By destruction of the substances in the
presence of an expressly authorized agent of the Commissioner; or
6. By transfer of the substance to a
registered reverse distributer; or
7. By such other means as said Regional
Director may determine; and
(3) Persons transferring controlled
substances pursuant to
105
CMR 700.006(H)(2)(c) may
make such transfers without being registered to do so; and upon the completion
of such disposition, shall file with the Commissioner on a form approved or
provided by him a final report of such disposition.
(I)
Filing of Prescriptions by
Pharmacies in Registered Health Facilities. Every pharmacy located
in a health facility registered with the Commissioner shall file prescriptions
for controlled substances as follows:
(1)
Prescriptions for controlled substances listed in Schedules I and II shall be
filed separately from all other prescriptions of the pharmacy in a file
identified for controlled substances listed in Schedules I and II
only;
(2) Prescriptions for
controlled substances listed in Schedules III, IV, and V shall be filed
separately from all other prescriptions of the pharmacy in a file identified
for controlled substances listed in Schedule III, IV and V only; and
(3) Prescriptions for controlled substances
listed in Schedule VI and prescriptions for non-controlled substances shall be
filed separately from all other prescriptions of the pharmacy in a file
identified for controlled substances listed in Schedule VI and non-controlled
substances.
