[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