Hypothetical Scenario- Drug Enforcement Administration
To
Mickey Disney,
The Supervisor
Date: April 10, 2019
Sub: 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 with whether, DEA 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 are 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 pays for the months’ supply, and the practitioner do not want to 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 Administration DEA, 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 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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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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