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The Problem

You are a Summer Legal Intern at the Drug Enforcement Administration


(DEA). The agency has been noticing that many people have been attempting to
fill their prescriptions for the drug marijuana, a controlled substance, from online
pharmacies. Many of these pharmacies are new operations, and the DEA wants to
make sure that they are complying with the law. In particular, the Agency wants to
be sure these online pharmacies are in compliance with the registration procedures
and fees, as well as the Controlled Substances Act. Your supervisor asks you to
perform a bit of research on this issue.

Question 1

Your supervisor is fairly certain that the DEA has previously addressed the issue of
online pharmacies. She remembers there is a regulation on the issue from
April 2009 that specifically addresses requirements online pharmacies must meet
in order to be in compliance with the Controlled Substances Act. She thinks there
is something in there about applying to distribute controlled substances.

What must an already licensed online pharmacy do first in order to distribute a


controlled substance? Who is in charge of approval? Please cite the regulation in
the Federal Register in your answer (e.g. 62 Fed. Reg. 1394).
(Hint: Try looking through the Federal Register, start with the April 6, 2009 issue).
Question 2

Now that you have the cite for this regulation from the Federal Register, can you
find the final regulation in the CFR? Please include the citation to the CFR.

(Hint: The easiest place to find this is the CFR on FDsys, remember, the CFR is
arranged by date and then by Title. Try looking through the 2010 edition.)

Question 3

Since this regulation is a few years old, you realize youll likely need to update it
to make sure it is still in force. Try looking up the regulation, using the cite you
found from Question 2. Is it still good law? How do you know (describe your
research steps)?

(Hint: Use Westlaw for this portion, as it will be easier to update using
KeyCite. Also, be sure to mention how current the CFR database is).
Question 4

The DEA charges annual registration fees for pharmacies that are licensed to
distribute controlled substances. The Agency feels that raising registration fees
might help to curb the number of online pharmacies dealing in marijuana.

Your supervisor would like to know:


(1) The last time fees were raised
(2) How much the proposed "weighted-ratio option" would raise fees for
pharmacies, and
(3) Would like you to include a comment raised about why or why not the fee
should've been raised?

(Hint: Try an Advanced Search on Regulations.gov, search something like "online


pharmacies" and "controlled substances". Remember to filter your results to
proposed rules and to only DEA results)
Question 5

As you continue to research this issue, it suddenly occurs to you that you are
unsure what class of drug marijuana is. Your supervisor mentions to you that the
DEA's Diversion Control Division has a resource called "The Orange Book" which
lists such drugs.
You are also aware that each state treats medical marijuana use differently and
would like to know what other states, aside from Arizona, allow marijuana for
medical use only.
a. Try finding the list of controlled substances issued by the DEA and include
marijuana's classification and DEA Drug Code Number.
(Hint: Use the Diversion Control Division Website for Part I. Browse the
materials under "Resources" for a list of controlled substances. Notice there is
a link for "Drug Code Numbers".)

b. Then try looking through the DEA's statistics page to find how many states
allow "State Approved Medical" Marijuana use.
(Hint: Start with the DEA agency website, then go to the Resource Center on
the side for stats)

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