Accordingly, the DEA declines to exempt manufacturers or distributors from the physical security requirements applicable to HCPs upon control in schedule II.
As stated, scheduling determinations are based on scientific determinations regarding the drug or other substance's potential for abuse, its potential for psychological and physical dependence, and whether the drug or other substance has a currently accepted medical use in treatment in the United States. A multi-pronged approach, one that includes education, treatment, monitoring, and law enforcement is needed to combat this epidemic. Likewise, two commenters suggested that cumbersome and slow ordering processes for schedule II substances will cause local shortages of HCPs, and thus practitioners will turn to prescribing other drugs.
According to representatives from 3 industry organizations, those decisions likely stem from issues with pharmacy quality and safety processes, payer reimbursement policies, and conflicting state laws.
For the reasons set out above, 21 CFR part 1308 is amended as follows: The State Attorney General and a U. Contrary to statements made by some ultimate users, even low doses of HCPs have the potential for adverse impacts on the public health and safety.
For example, in 2012 six nursing home employees in Oklahoma were charged with operating a drug ring out of the facility for whom they were employed. Establishment of a National Prescription Drug Monitoring Program PDMP Several commenters requested the implementation of a national prescription drug monitoring program PDMP either as an alternative to rescheduling HCPs, or possibly in addition thereto, as a means of curtailing doctor shopping and preventing abuse.
Accordingly, all of the historical data regarding hydrocodone from different national and regional databases that support this rule should refer to HCPs only, regardless of whether the database utilizes the term "hydrocodone" or "hydrocodone combination products. In accordance with 21 CFR 1306. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.
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Increased production of HCPs is directly due to the increased prescription of these drugs to treat and alleviate pain. All other products containing hydrocodone are already controlled in schedule II of the CSA and are not impacted by this action. Register the vetted patients in the state drug monitoring programs as 'OK' to obtain 90-day supplies. Many commenters also voiced concerns about possible effects of rescheduling on the elderly and disabled.
Written By: APhA and most pharmacy groups strongly opposed the move. This is an unofficial version.
Criteria for Abuse One commenter wanted the DEA to draw distinctions among abuse, addiction, and dependence. This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995 44 U.
One commenter stated that many EDs do not typically prescribe schedule II narcotics. Another commenter suggested there will be local shortages of HCPs because of the cumbersome and slow schedule II ordering process. Monitoring Access A national advocacy group for cancer patients requested that the DEA "require monitoring plans and an annual report to Congress, in the event that HCPs are upscheduled, that assess the impact on access by patients with legitimate needs, as emphasized and urged by HHS" and to "adjust policy accordingly if it finds that access is impeded for patients who legitimately need HCPs for pain management.