Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 19 - DANGEROUS DEVICES AND SUBSTANCES
Chapter 10.19.03 - Controlled Dangerous Substances
Section 10.19.03.10 - Miscellaneous (21 CFR Section1307)
Universal Citation: MD Code Reg 10.19.03.10
Current through Register Vol. 51, No. 19, September 20, 2024
A. Distribution by Dispenser to Another Practitioner (21 CFR § 1307.11).
(1) A practitioner who is registered to
dispense a controlled dangerous substance may distribute (without being
registered to distribute) a quantity of the substance to another practitioner
for the purpose of general dispensing by the practitioner to the practitioner's
patients, if:
(a) The practitioner to whom
the controlled dangerous substance is to be distributed is registered under the
Act to dispense that controlled dangerous substance;
(b) The distribution is recorded by the
distributing practitioner in accordance with
21 CFR § 1304.22(c), and by the
receiving practitioner in accordance with
21 CFR § 1304.22(c);
(c) The substance is listed in Schedule I or
II, an order form is used as required in Criminal Law Article, §5-303(d),
Annotated Code of Maryland; and
(d)
The total number of dosage units of all controlled dangerous substances
distributed by the practitioner pursuant to this section and
21 CFR § 1301.25 during each calendar year in which
the practitioner is registered to dispense does not exceed 5 percent of the
total number of dosage units of all controlled dangerous substances distributed
and dispensed by the practitioner during the same calendar year.
(2) If, at any time during any
calendar year during which the practitioner is registered to dispense, the
practitioner has reason to believe that the total number of dosage units of all
controlled dangerous substances which will be distributed by the practitioner
pursuant to this regulation will exceed 5 percent of the total number of dosage
units of all controlled dangerous substances distributed and dispensed by the
practitioner during that calendar year, the practitioner shall obtain a
registration to distribute controlled dangerous substances.
B. Distribution to Supplier ( 21 CFR § 1307.12).
(1) Any person lawfully
in possession of a controlled dangerous substance listed in any schedule may
distribute (without being registered to distribute) that substance to the
person from whom the person obtained it or to the manufacturer of the
substance, provided that a written record is maintained which indicates the
date of the transaction, the name, form and quantity of the substance, the
name, address, and registration number, if any, of the person making the
distribution, and the name, address, and registration number, if known, of the
supplier or manufacturer. In the case of returning a controlled dangerous
substance listed in Schedule I or II, an order form shall be used in the manner
prescribed in 21 CFR § 1305, and be maintained as the written record of
the transaction. Any person not required to register pursuant to §§
302C or 1007(b)(1) of the Federal Act (21 U.S.C. § 822(c) or
957(b)(1)) shall
be exempt from maintaining the records required by this regulation.
(2) Distributions referred to in §B(1)
of this regulation may be made through a freight forwarding facility operated
by the person to whom the controlled substance is being returned, provided that
prior arrangement has been made for the return and the person making the
distribution delivers the controlled substance directly to an agent or employee
of the person to whom the controlled substance is being returned.
C. Distribution upon Discontinuance or Transfer of Business 21 CFR § 1307.21 .
(1) A registrant desiring to discontinue
business activities altogether, who has controlled dangerous substances in the
registrant's possession, may have these substances destroyed in accordance with
§D of this regulation. A registrant shall return the State certificate of
registration to the Division of Drug Control.
(2) A registrant desiring to discontinue
business activities altogether, or with respect to controlled dangerous
substances (by transferring those business activities to another person), shall
submit in person or by registered or certified mail, return receipt requested,
to the Secretary of the Department of Health and Mental Hygiene, Attention:
Division of Drug Control, at least 14 days before the date of the proposed
transfer (unless the Secretary waives this time limitation in individual
instances), the following information:
(a)
The name, address, registration number, and authorized business activity of the
registrant discontinuing the business (registrant-transferor);
(b) The name, address, registration number,
and authorized business activity of the person acquiring the business
(registrant-transferee);
(c)
Whether the business activities will be continued at the location registered by
the person discontinuing business, or moved to another location (if the latter,
the address of the new location should be listed);
(d) The date on which the transfer of
controlled dangerous substances will occur.
(3) Unless the registrant-transferor is
informed by the Secretary, before the date on which the transfer was stated to
occur, that the transfer may not occur, the registrant-transferor may
distribute (without being registered to distribute) controlled dangerous
substances in the registrant-transferor's possession to the
registrant-transferee in accordance with the following procedures:
(a) On the date of transfer of the controlled
dangerous substances, a complete inventory of all controlled dangerous
substances being transferred shall be taken in accordance with
21 CFR § 1304.11. This inventory shall serve as the
final inventory of the registrant-transferor and the initial inventory of the
registrant-transferee, and a copy of the inventory shall be included in the
records of each person. It is not necessary to file a copy of the inventory
with the Department unless requested by the Secretary. Transfers of any
substances listed in Schedule I or II shall require the use of order forms in
accordance with 21 CFR § 1305.
(b) On the date of transfer of the controlled
dangerous substances, all records required to be kept by the
registrant-transferor with reference to the controlled dangerous substances
being transferred, under 21 CFR § 1304, shall be transferred to the
registrant-transferee. Responsibility for the accuracy of records before the
date of transfer remains with the transferor, but responsibility for custody
and maintenance shall be upon the transferee.
(c) In the case of registrants required to
make reports pursuant to 21 CFR § 1304, a report marked "Final" shall be
prepared and submitted by the registrant-transferor showing the disposition of
all the controlled dangerous substances for which a report is required. An
additional report is not required from the registrant-transferor, if no further
transactions involving controlled dangerous substances are consummated by the
registrant-transferor. The initial report of the registrant-transferee shall
account for transactions beginning with the day next succeeding the date of
discontinuance or transfer of business by the transferor-registrant, and the
substances transferred to the registrant-transferee shall be reported as
receipts in the registrant-transferee's initial report.
D. Procedure for Disposing of Legally Obtained Controlled Dangerous Substances ( 21 CFR § 1307.21).
(1) Any registrant in possession of legally
obtained controlled dangerous substances and desiring or required to dispose of
any of these substances may ask the Division of Drug Control of the Department
of Health and Mental Hygiene for authority and instructions to dispose of this
substance. This does not eliminate the requirement on registrants under federal
regulations to report destruction of controlled dangerous substances.
(2) The request should be made as follows:
(a) If the registrant is required to make
reports pursuant to 21 CFR § 1304, the registrant shall list the
controlled dangerous substance or substances which the registrant desires to
dispose of and submit one copy of the request to the Division of Drug Control
of the Department of Health and Mental Hygiene.
(b) If the person is a registrant not
required to make reports pursuant to 21 CFR § 1304, the person shall list
the controlled dangerous substance or substances which the person desires to
dispose of on a form required by the Department, and submit a copy of that
report to the Division of Drug Control of the Department of Health and Mental
Hygiene.
(3) The
division of Drug Control shall authorize and instruct the registrant to dispose
of the controlled dangerous substance in one of the following manners, provided
complete records of the disposition are maintained by the registrant:
(a) By transfer to a person registered under
the Act and authorized to possess the substance;
(b) By destruction in the presence of an
agent of the Division of Drug Control or other authorized person;
(c) By forwarding to the District Office of
the Drug Enforcement Administration pursuant to the procedures of that
agency;
(d) In a facility
registered to administer only, two members of the professional staff
(administrator, nurse, pharmacist) may destroy controlled drugs on the
premises; a record of the disposal shall be recorded on a form to be supplied
by the Division of Drug Control, a copy of which is to be forwarded to the
Division within 10 days of destruction;
(e) Aforementioned procedures do not preclude
release of medication to discharged patients if so ordered in writing by the
attending physician;
(f) Unused
controlled dangerous substances dispensed by registered hospital pharmacies for
administration to in-patients shall be returned to the pharmacy for appropriate
disposition;
(g) By other means
that the Secretary may determine to assure that the substance does not become
available to unauthorized persons.
(4) If a registrant is required regularly to
dispose of controlled dangerous substances, the Special Agent in Charge of the
Federal Drug Enforcement Administration may authorize the registrant to dispose
of these substances, in accordance with 21 CFR § 1307.21(b), without prior
approval of the Drug Enforcement Administration in each instance, on the
condition that the registrant keep records of these disposals and file periodic
reports with the Special Agent in Charge summarizing the disposals made by the
registrant. In granting authority, the Special Agent in Charge may place
conditions that the Special Agent in Charge deems proper on the disposal of
controlled dangerous substances, including the method of disposal and the
frequency and detail of reports.
E. Disposal of Controlled Dangerous Substances by the Federal Drug Enforcement Administration (21 CFR § 1307.22). Any controlled dangerous substances delivered to the Federal Drug Enforcement Administration under 21 CFR § 1307.21, or forfeited pursuant to § 511 of the Federal Act (21 U.S.C. 881), may be delivered to any department, bureau, or other agency of the United States or of any state upon proper application addressed to the Administrator of the Drug Enforcement Administration, Department of Justice, Washington, D.C. The application shall show the name, address, and official title of the person or agency to whom the controlled dangerous substances are to be delivered, including the name and quantity of the substances desired and the purpose for which intended. The delivery of these controlled dangerous substances shall be ordered by the Administrator, if, in the Administrator's opinion, there exists a medical or scientific need for it.
F. Native American Church (21 CFR § 1307.31).
(1) The listing of peyote as a controlled
dangerous substance in Schedule I under Criminal Law Article, §5-402, Annotated Code of
Maryland, does not apply to the nondrug use of peyote in bona fide religious
ceremonies of the Native American Church, and members of the Native American
Church using peyote in this manner are exempt from registration.
(2) A person who manufactures peyote for, or
distributes peyote to, the Native American Church is required to obtain
registration every 2 years and to comply with all other requirements of
law.
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