Schedule II Stimulant Medications Are Subject to the Same Prescribing Limitation as Opioids
By Jessica Ridge

While many physicians are aware of the U.S. Drug Enforcement Administration (DEA) rules for prescribing a 90-day supply of an opioid medication, fewer may know the requirements extend to all Schedule II controlled substances, which includes stimulants. 

The DEA has published a list of Schedule II controlled substances. 

The Controlled Substance Act (CSA) prohibits refills of Schedule II medications. However, a federal rule adopted in 2007 authorizes a physician to issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance – but only if certain conditions are met – such as indicating the earliest date on which a pharmacy may fill each prescription, among others.  

Additionally, the 2007 rulemaking acknowledged that though the “CSA and DEA regulations contain no specific limit on the number of days’ worth of a Schedule II controlled substance that a physician may authorize per prescription[, t]he essential requirement under federal law is that the prescription for a controlled substance be issued for a legitimate medical purpose in the usual course of professional practice.” 

 Though not explicitly adopted as a maximum time frame, the rulemaking repeatedly contemplated prescribing Schedule II controlled substances in a 30-day supply. 

Susan Wynne, MD, a San Antonio and Fredericksburg child, adolescent, and adult psychiatrist, was caught unaware of the DEA rule’s impact prescribing Schedule II stimulants. She learned of it only after the audit of a pharmacy that filled a prescription for a 90-day supply of stimulants she had written. A letter from DEA notified Dr. Wynne she had allegedly violated the federal rule discussed above, Section 1306.12(b)(1) of Title 21 of the Code of Federal Regulations.   

Following the DEA’s letter, Dr. Wynne was then required to spend hours communicating with an attorney to compose the response requested by the agency. As she navigated the violation’s fallout, which she’s since resolved, Dr. Wynne identified a knowledge gap – awareness was scarce of the regulation’s applicability to 90-day prescriptions for all Schedule II controlled substances being filled all at once. 

“Nobody knows about this,” she found, after conferring with psychiatrist colleagues and pharmacies. “I regularly receive requests for 90 days [of stimulant medication] all at once from local pharmacies and from mail-order pharmacies. The only way to write for a 90-day supply is to write three separate 30-day prescriptions.  For example, a physician can write for one 30-day prescription dated today, another 30-day prescription with an earliest fill date of 30 days from the date of the initial prescription and another 30-day prescription with an earliest fill date of 60 days from the date of the initial prescription.”  

Electronic prescribing for controlled substances systems may not automatically be calibrated to generate an alert when a physician writes a prescription or prescriptions for a 90-day supply of a Schedule II controlled substance. Additionally, pharmacy systems may not flag requests that could violate this regulation. Pharmacies that fill such prescriptions run the risk of an audit that also identifies the physician who wrote the prescription. 

Pharmacies Texas Medicine Today reached out to did not respond with comment on the stimulant prescription rule. 

Unfamiliarity with the rule’s reach could pose a risk to a broad swath of physicians.  

“Psychiatrists are not the only physicians writing for stimulant medications,” said Dr. Wynne, a consultant to TMA’s Committee on Behavioral Health, noting that she doesn’t prescribe any other Schedule II medications. “Family medicine, pediatrics, internal medicine, neurology, pediatric neurology – those are all physician specialties who may regularly write for stimulant medications.” 

“It’s disruptive to get notification by the DEA that you are reportedly violating a federal rule,” she said, calling the legwork required to address the situation time-consuming. “I don’t want anyone to go through what I went through.” 

TMA staff recommends physicians be vigilant of the requirements for prescribing Schedule II controlled substances. Additionally, physicians may check with their electronic health record or electronic prescribing vendor to see if guardrails can be put in place that provide an alert when a physician attempts to prescribe a Schedule II controlled substance in a manner that may violate the DEA’s rule. 

Find more resources and information on prescribing in Texas on TMA’s dedicated webpage. 

Disclaimer: This information is provided as general information and is not intended to provide advice on any specific legal matter. This information should NOT be considered legal advice and receipt of it does not create an attorney-client relationship. This is not a substitute for the advice of an attorney. The TMA Office of the General Counsel provides this information with the express understanding that (1) no attorney-client relationship exists, (2) neither TMA nor its attorneys are engaged in providing legal advice, and (3) the information is of a general character. Although TMA has attempted to present materials that are accurate and useful, some material may be outdated, and TMA shall not be liable to anyone for any inaccuracy, error or omission, regardless of cause, or for any damages resulting therefrom. You should not rely on this information when dealing with personal legal matters; rather legal advice from retained legal counsel should be sought. Any forms are only provided for the use of physicians in consultation with their attorneys.

Certain links provided with this information connect to other websites maintained by third parties. TMA has no control over these websites, or the information, goods, or services provided by such third parties. TMA shall have no liability for any use or reliance of a user on these third-party websites