10.19.03.10

.10 Miscellaneous (21 CFR §1307).

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 Health, 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 Maryland Department of Health 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 Maryland Department of Health.

(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 Maryland Department of Health.

(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.