[Federal Register Volume 61, Number 182 (Wednesday, September 18, 1996)]
[Proposed Rules]
[Pages 49086-49087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23816]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

RIN 1117-AA40, DEA Number 142N


Guidelines for Providing Controlled Substances to Ocean Vessels

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Advance Notice of Proposed Rulemaking.

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SUMMARY: DEA is considering whether to propose amending the regulations 
regarding the supply of controlled substances to ocean vessels to 
provide a means of supply more consistent with current industry 
practices for other materials. The decision on whether to propose 
amendments and the extent of any such amendments will be based on the 
information and comments submitted in response to this advance notice 
of proposed rulemaking and DEA's experience with the existing 
procedures and practices for supplying controlled substances to 
vessels.

DATES: Information and comments should be submitted on or before 
November 18, 1996.

ADDRESSES: Comments should be submitted in duplicate to the Deputy 
Assistant Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, D.C. 20537, Attn: Federal Register 
Representative/CCR.

FOR FURTHER INFORMATION CONTACT:
G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of 
Diversion Control, Drug Enforcement Administration, Washington, D.C. 
20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION: Title 21, Code of Federal Regulations (CFR), 
Section 1301.28 provides a mechanism for the transfer of controlled 
substances to ocean vessels for use in emergency

[[Page 49087]]

kits. Vessels may obtain controlled substances either through the 
services of a medical officer who is employed by the owner or operator 
of the vessel and is registered with DEA as a practitioner, or, in the 
absence of a medical officer, through the master or first officer of 
the vessel personally appearing before a distributor registrant and 
receiving the controlled substances directly.
    If a medical officer is ordering the controlled substances, he or 
she shall submit the order to a distributor or, when allowed pursuant 
to 21 CFR 1301.28(f), a pharmacy. When filling the order, the 
distributor or pharmacy must handle the transaction as a normal 
distribution subject to all of the requirements of the law and 
regulations regarding the distribution of controlled substances. If 
Schedule II controlled substances are being ordered, a properly 
completed and signed DEA Order Form (DEA Form-222) must be received 
prior to filling the order. Further, all controlled substances must be 
shipped directly to the medical officer at his or her registered 
address. The distributor or pharmacy may not ship the controlled 
substances to another person or address. The medical officer shall 
transfer the controlled substances to the vessel only at a location 
within the United States. The shipment of controlled substances to a 
foreign location can be accomplished only by a registered exporter 
pursuant to a valid export permit or declaration and authorization of 
the foreign government; to do so otherwise could be a criminal 
violation of the Controlled Substances Act (CSA) and U.S. International 
Treaty obligations.
    In the absence of a registered medical officer, the master or first 
officer of an ocean vessel may obtain controlled substances by 
appearing personally before a distributor or an authorized pharmacy 
registrant, and by presenting proper identification and a written 
requisition for the controlled substances. The requisition must be 
prepared on the vessel's official stationery or purchase form and must 
contain the information required by 21 CFR 1301.28(d)(2). The 
distributor or pharmacy shall record the distribution in the manner 
required by 21 CFR 1301.28(d)(4). The master or first officer of a 
vessel must appear personally before the registrant to receive the 
controlled substances.
    Issues regarding practical compliance with the regulations have 
arisen, including the use of contract practitioners, the shipping of 
controlled substances to other than a registered location, exporting 
controlled substances without an exporter registration and export 
permit or declaration, repacking or relabelling controlled substances 
in violation of the CSA, and, in the absence of a medical officer, 
shipping controlled substances to a vessel rather than requiring a 
personal appearance by the master or first officer.
    DEA has also received comments from wholesalers and owners/
operators of vessels expressing concerns regarding the regulations and 
the impact they have on the delivery of controlled substances to the 
vessels. The primary concern is the requirement that controlled 
substances ordered by a medical officer must be shipped to the medical 
officer's registered location by the distributor. The medical officer 
then must ship the controlled substances to the vessel. The commentors 
have objected that this requirement delays the delivery of the 
controlled substances to the vessel and increases the potential for 
diversion of the substances. Comments have also been received regarding 
the use of medical officers, the distribution of controlled substances 
to vessels in foreign ports, and the use of ship's agents to help 
effect the delivery of controlled substances to the vessels.
    In order to better understand the circumstances under which the 
maritime industry operates and to determine what regulatory adjustments 
might be possible to allow a more efficient and practical means to 
provide controlled substances to ocean vessels while maintaining 
controls against the diversion of controlled substances, DEA is 
requesting information and comments regarding the following:
    1. What industry standards or requirements are there regarding the 
acquisition, storage, and dispensing of controlled substances aboard 
ocean vessels? If there are standards or requirements, is there a 
mechanism for ensuring compliance and sanctioning those that fail to 
comply? Further, do the standards or requirements apply to all vessels, 
including foreign flag vessels, or do they apply only to U.S. flag 
vessels?
    2. Are there standardized procedures for delivering materials/
supplies to vessels when they are in port? What provisions are there 
for the safekeeping/security of sensitive materials/supplies prior to 
the actual delivery to the vessel?
    3. What duties do ship/port agents and ship chandlers perform? What 
legal responsibilities must they satisfy and to whom are they 
responsible? Are there specific guidelines or requirements that must be 
adhered to and a mechanism for enforcing compliance?
    In addition to developing background information concerning the 
operations of the maritime industry with respect to providing vessels 
with controlled substances, DEA is also seeking comments and proposals 
from interested parties regarding the impact of the current regulatory 
requirements and possible alternative procedures that might better 
serve the industry while preserving the necessary safeguards to prevent 
diversion. Areas of specific interest would include the use of contract 
medical officers, the shipment of controlled substances from the 
distributors to the vessels, and whether ship/port agents and chandlers 
can participate in the process. DEA also welcomes any comments and 
suggestions on related issues regarding the supply of controlled 
substances to ocean vessels.
    Interested persons may, on or before November 18, 1996, submit to 
the Deputy Assistant Administrator, Office of Diversion Control, Attn: 
Federal Register Representative/CCR (address above) two copies of the 
written information and comments regarding this advance notice of 
proposed rulemaking.

    Dated: August 19, 1996.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 96-23816 Filed 9-17-96; 8:45 am]
BILLING CODE 4410-09-M