(Summary)
July 19, 1999
Patricia Good opened the meeting, noting that the
regulatory process is a two-way process that relies on the valuable
expertise of industry. Ms. Good introduced Bill Wolf, Special Assistant
to the Deputy Assistant Administrator.
National Methamphetamine Picture
Mr. Wolf reported on national
trends. Seventy "superlabs" represent 78% of United States
(U.S.)
methamphetamine production capability. Most other labs are tiny ( 95% of
clan labs account for the remaining 22% of production capability). This
means that meeting participants represent that segment of industry on
whose voluntary initiatives government depends for combating 95% of
clandestine labs. The Federal 24 gram retail sales limit
and industry’s voluntary efforts have been helpful in limiting
large scale production. These efforts have not been sufficient, however,
to prevent the continued increase in small (4 ounces or less)
clandestine labs. John Uncapher presented specific examples of the
trends which Mr. Wolf described.
Surveillance List/Chemical Mixtures
Special Surveillance List
Frank Sapienza explained the recently published Special Surveillance
List of chemicals and equipment which can be used in the illicit
production of controlled substances or listed chemicals. Additions or
deletions to the Special Surveillance List will be made by means of the
Federal Register notice process.
Chemical Mixtures
The only exempt chemical mixtures are those that cannot be used to
produce controlled substances and cannot be extracted from controlled
substances. By regulation the Drug Enforcement Administration (DEA) must identify exempted mixtures. DEA is
currently reviewing comments on a proposed rule before issuing a final
regulation. The proposed rule contains a three-tiered approach.
Registration
Frank Moreno reported that a Federal Register
notice on fees is being prepared. There will be a significant reduction,
but the new fee will exceed the current
$116 fee.
Policy, Legislative and Regulatory Issues
Mail Order Andy
McFaul explained that Internet sales are covered by the mail order
reporting requirement. Although Internet sales appear to be at the
retail level, sales in the electronic setting are not retail. The
face-to-face requirement that is a key element of the retail definition
is missing. Internet transactions are similar to written or telephone
orders -- the purchaser retains anonymity and the seller’s ability to
determine the legitimacy of the transaction is diminished.
CSA Registrant Exemption
Mr. McFaul spoke about the CSA registrant issue regarding freight
forwarding/cross docking. DEA is considering whether an exemption for
controlled substances justifies a similar exemption for
chemical sales.
Brokers/Internet
Mr. McFaul spoke about current situations where drug product suppliers
and Internet providers enter into partnerships. Due to the manner in
which the transactions are constructed, the Internet provider may have
to register as a distributor.
Suspicious Orders Task Force (SOTF) Mr.
Wolf reported that the Department of Justice (DOJ) has completed its review of the task force report
and that final clearance is anticipated in the near future. Many
companies involved in diversion are selling large quantities of drug
product as retailers. They do not meet the definition of retail
distribution. Although DEA does not expect wholesalers to become
policemen, they must be aware of where their products go.
Mr. Wolf then discussed the
Federal 24 gm retail limit and industry’s voluntary efforts to
establish even lower limits on all products including exempt safe harbor
products. Although these efforts have been helpful in limiting
methamphetamine production, they have not been sufficient to prevent a
continued increase in small (4 ozs or less) clandestine methamphetamine
labs. He asked industry to consider this issue and to suggest solutions
that would be practical for industry.
DEA is receiving fewer notifications of suspicious
orders than anticipated. Michael Stulberg of the American Wholesale
Marketers Association asked what DEA can do to provide feedback to
reporters of suspicious orders. He said that distributors who have
notified DEA of suspicious customers have subsequently lost sales to
competitors. Lacking feedback from DEA, they doubt the effectiveness of
the notification system. Mary Ann Wagner, Vice President for Pharmacy
Affairs for the National Association of Chain Drug Stores, agreed and
emphasized the importance of getting back to callers. Many members
report to her that they receive no follow-up calls. Mary Kate Whalen,
DEA Office of Chief Counsel, interjected that DEA is precluded from
disclosing investigative information. DEA
can, however, advise that action is being taken as a result of a report.
We can only tell industry that their tips do matter.
Pharmacy Curriculum
A participant noted that conversations with pharmacy school graduates in
several states revealed that little or no time is devoted to the
requirements of the MCA. It was recommended that DEA contact pharmacy
schools to request that the MCA requirements be added to the curriculum.
Summary Mr. Wolf
again raised the possibility of eliminating the 1000 count bottles and
moving to safe harbor packaging, as recommended in the Supplementary
Report of the Suspicious Orders Task Force. He noted that this could be
accomplished voluntarily.
He concluded by urging industry to consider
adopting several measures:
- Act on the SOTF recommendation to move to
smaller package sizes now.
- Implement the SOTF guidelines and indicators
now.
- Cut off customers who will not cooperate on
retail limits.
- In setting voluntary limits, review state
actions for useful benchmarks.
- Incorporate SOTF guidelines in codes of
conduct or good practices policies.
Conclusion
Ms. Good thanked the group for participating. The
next meeting will be in about six months.
Attendees
Name |
Association |
Corporation |
Mary
Ann Wagner |
National Association of Chain Drug Stores
(NACDS) |
|
James (Mickey) Carter |
NACDS |
Eckerd Corporation |
Kevin Kraushaar |
Consumer Healthcare Products Association |
|
Jacqueline Cohen |
American Wholesale Marketers Assoc (AWMA) |
|
Michael M. Stulberg |
AWMA |
Somody Supply Inc. |
John Thomas |
AWMA |
Luman, Lang & Wheeler |
Diane Goyette |
National Wholesale Druggists Association |
|
John Rector |
Natl Community Pharmacists Association (NCPA) |
|
Doug Hoey |
NCPA |
|
Paul Koerner |
NCPA |
|
Ty Kelley |
Food Marketing Institute |
|
Gale Prince |
Food Marketing Institute |
The Kroger Co. |
Jonathan Eisen |
Food Marketing Institute |
|
David Durkin |
Food Marketing Institute |
Olsson, Frank and Weeda, PC |
Lyle Beckwith |
Natl Assoc of Convenience Stores |
|
DEA: |
|
|
John H. King |
Deputy Asst. Administrator |
Office of Diversion Control |
William Wolf |
Special Assistant |
|
Michael Fredericks |
Chief, Chemical Operations |
|
John Uncapher |
Chief, Domestic Chem Inv. |
|
Patricia Good |
Chief, Liaison & Policy |
|
Frank Sapienza |
Chief, Drug & Chem Eval. |
|
Frank Moreno |
Chief, Data Proc & Analysis |
|
Mark Via |
Data Proc & Analysis |
|
Sharon Partlo |
Acting
Chief, Policy Unit |
|
Andrew McFaul |
Policy Unit |
|
Michelle Ferritto |
Policy Unit |
|
Denise Curry |
Chief, Liaison Unit |
|
Mike Leser |
Liaison Unit |
|
Rosemarie Greenlee |
Liaison Unit |
|
Sally Haskell |
Liaison Unit |
|
Mary Kate Whalen |
|
Office of Chief Counsel |
Serafina Lobsenz |
|
Office of Chief Counsel |
Full Report