Memorandum: Proposed DEA Rule on Narcotic Prescription and Dispensing

This memorandum, addressed to Mickey Disney, a supervisor at the Drug Enforcement Administration (DEA), proposes a new rule concerning the prescription and dispensing of controlled drugs for narcotic-dependent individuals undergoing detoxification treatment. The proposal seeks to clarify the practice of using the "Do Not Fill Until" method for Schedule II controlled substances, addressing conflicts between prescription guidelines and insurance practices. The memorandum also explores the potential for negotiated rulemaking, analyzing factors such as the necessity of the rule, the number of affected parties, and the willingness to negotiate in good faith to reach a consensus. It references relevant sections of the Electronic Code of Federal Regulations and federal register notices to support its arguments and proposes a framework for implementing the new rule effectively.

MEMORANDUM
Memorandum
HYPOTHETICAL SCENARIO- DRUG ENFORCEMENT
ADMINISTRATION
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MEMORANDUM
To
Mickey Disney,
The Supervisor
Date: April 10, 2019
Sub:a Proposed rule allowing qualified practitioners to dispense and prescribe to narcotic
dependent persons certain controlled drugs that are approved by the FDA for detoxification
treatment, along withwhetherDEA can opt for negotiated rulemaking
Dear Mr. Disney
This is to inform you that, I have been assigned to draft a proposed rule for allowing qualified
practitioners to dispense and prescribe to narcotic dependent persons certain controlled drugs that
are approved by the FDA for detoxification treatment as mentioned under (Federal Register
Notices > Rules - 2005 > Authority for Practitioners To Dispense or Prescribe Approved
Narcotic Controlled Substances for Maintenance or Detoxification Treatment).
The proposed rule is for clarification for the practice of using “Do Not Fill Until ___” method
which is used for writing prescriptions required for prescribing the Schedule II controlled
substance. As the code of federal regulations under section 1306.05 states the manner for issuing
the prescriptions for controlled substances(Electronic Code of Federal Regulations- Title 21 →
Chapter II → Part 1306 →§1306.05 Manner of issuance of prescriptions), however, for
prescribing opioid under Schedule II controlled substance, the quantity of medications must be
divided in half, so, for each prescription the issuing date will be same, but in another it will
above- mentioned method. The patient with stable pain generally comes in a clinic in 2 months’
time, but insurance companies pay for the months' supply, and the practitioner does not want to
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MEMORANDUM
supply the medicine for more than 1 week, as mentioned under (Electronic Code of Federal
Regulations- Title 21 → Chapter II → Part 1306 →§1306.12 Refilling prescriptions; issuance of
multiple prescriptions)).
Therefore, I request the Drug Enforcement AdministrationDEA, address this problem and allow
the refilling of a prescription for a Schedule II controlled substance.
Again, the concept of Negotiated rulemaking is farmed in such a way that both the parties reach
the accord based on the newly proposed rule before the rulemaking process is implemented. So,
to answer whether, Drug Enforcement Administration DEA can devise the use for negotiated
rulemaking, it is important to understand the factors for negotiated rule-making, which considers
the necessity of the rule to be formulated, along with the number of parties who will be
significantly affected , whether a committee will be sufficient to represent significant interest of
the affected parties and also whether those parties will be able to negotiate in good faith.
Furthermore, to reach the reasonable consensus necessary resources must be provided so as not
to hamper the rule-making process, and most importantly, whether there is the willingness to
make use of the rule which is negotiated.
Thus, the above- mentioned factors if made applicable in this situation, then for reaching the
consensus, the significant interest must be gathered who will help in highlighting the importance
of the above- mentioned proposed rule, while keeping in mind the adherence and the willingness
to implement the proposed rule.
Thanks and Regards,
Mr. Authentic Paralegal
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MEMORANDUM
References
Electronic Code of Federal Regulations- Title 21 → Chapter II → Part 1306 →§1306.05
Manner of issuance of prescriptions. (n.d.). Retrieved from https://www.ecfr.gov/cgi-
bin/text-idx?
SID=455d1fb28b9af2f6a36fbcf85fa6d992&mc=true&node=se21.9.1306_105&rgn=div8
Electronic Code of Federal Regulations- Title 21 → Chapter II → Part 1306 →§1306.12
Refilling prescriptions; issuance of multiple prescriptions. (n.d.). Retrieved from
https://www.ecfr.gov/cgi-bin/text-idx?
SID=455d1fb28b9af2f6a36fbcf85fa6d992&mc=true&node=se21.9.1306_112&rgn=div8
Federal Register Notices > Rules - 2005 > Authority for Practitioners To Dispense or Prescribe
Approved Narcotic Controlled Substances for Maintenance or Detoxification Treatment.
(n.d.). Retrieved from
https://www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0623.htm
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