Understanding DEA Compliance for Emergency Schedule II Prescriptions in Long-Term Care Pharmacies

Introduction to Emergency Schedule II Prescription DEA Compliance

This post is a bit different from my usual content, but it covers an important topic: emergency Schedule II prescription in long-term care pharmacies (LTC Pharmacies) and long-term care facilities (LTCFs). According to DEA regulations (21 CFR 1300.01), a “Long-Term Care Facility” is defined as a nursing home, retirement care, mental health care, or other institution that provides extended health care to resident patients.

Why is this critical? Many LTC Pharmacies fail to follow these regulations correctly, exposing themselves to serious administrative and civil penalties. There have been numerous enforcement actions over the years, including:

• 2012 Omnicare Settlement – The Justice Department reached a $50 million settlement with Omnicare for violating the Controlled Substances Act by dispensing controlled substances without valid prescriptions or proper documentation. These violations included dispensing drugs without signed or oral practitioner prescriptions and failing to maintain accurate records.
• 2015 PharMerica Settlement – PharMerica agreed to pay $31.5 million for dispensing Schedule II narcotics without valid physician prescriptions and submitting false Medicare claims. The settlement included $8 million for Controlled Substances Act violations and $23.5 million for False Claims Act violations, along with a corporate integrity agreement requiring compliance reforms and independent reviews for five years.
• 2021 AlixaRX LLC – AlixaRX LLC, a national pharmacy provider for long-term care facilities, agreed to pay $2.75 million to settle allegations that it violated the Controlled Substances Act by improperly dispensing opioids and other controlled substances without valid prescriptions between 2014 and 2017. The government claimed AlixaRx abused emergency prescription provisions, failed to obtain timely written authorizations, and concealed violations through backdated prescriptions, while also submitting false Medicare claims. The settlement, stemming from a whistleblower lawsuit, resolves allegations without an admission of liability and highlights federal efforts to enforce prescription regulations and combat opioid misuse.
• 2025 PharMerica Settlement – PharMerica and its parent company have agreed to pay $778,000 to resolve allegations of Controlled Substances Act violations following a DEA inspection at their Houston location in June 2024. The inspection revealed serious recordkeeping failures, including incomplete and inaccurate records for all eight audited controlled substances, lack of readily retrievable dispensing records for seven substances, and insufficient documentation of transfers for collected drugs—issues that could facilitate diversion of highly addictive narcotics. Authorities emphasized that these lapses compromise public safety and underscored that failure to adhere to the law will result in substantial penalties to enforce accountability.

These are just four examples of many civil settlements involving LTC Pharmacies. In this post, we’ll explore the regulatory requirements and practical steps you can take to ensure compliance with DEA rules, with a focus on emergency schedule II-controlled substance prescriptions.

In my next post, we will dive into the emergency kits (EDK Kits) owned by the LTC Pharmacy but located at an unregistered LTCF.

Step-by-Step Guide to Handling Emergency Schedule II Prescriptions

Let’s outline the steps involved in receiving and dispensing a Schedule II controlled substance during an emergency, as detailed in 21 CFR 1306.11(d).

I realize some of you may review the steps below and think, ‘This isn’t how the industry operates,’ or ‘This seems overly burdensome.’ However, based on my experience investigating LTC Pharmacies, these very issues are a leading cause of significant civil penalties.

Before You Begin

There are two important topics which are discussed below in the first paragraph of 21 CFR 1306.11(d):

1. Confirm It’s a True Emergency

The situation must meet the definition outlined in 21 CFR 290.10, which requires all the following conditions:

(a) That immediate administration of the controlled substance is necessary, for proper treatment of the intended ultimate user; and

(b) That no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under schedule II of the Act, and

(c) That it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to the dispensing.

The word “and” between these conditions is critical—every requirement must be satisfied for the situation to qualify as an emergency.

With the widespread use of electronic prescribing, meeting condition (c) has become increasingly difficult since practitioners can often transmit prescriptions electronically from anywhere, therefore, the emergency no longer exists to call in the prescription.

2. The Prescription Must Be Called in by the Prescribing Practitioner

DEA regulations are clear: only the DEA-registered prescribing practitioner may call in an emergency Schedule II prescription. This responsibility cannot be delegated to nurses, facility staff, or anyone else. The call must come directly from the practitioner to the pharmacy to comply with federal law.

Step-by-Step Process

Step 1: Limit the Quantity Dispensed

Under 21 CFR 1306.11(d)(1), the prescription must be limited to the amount needed to treat the patient during the emergency period. If your LTC pharmacy delivers daily, an emergency should never extend beyond one day.

“The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a paper or electronic prescription signed by the prescribing individual practitioner);”

In my experience investigating pharmacies, emergency Schedule II prescriptions are typically limited to a standard 3, 5, or 7 days, with the duration often set by the pharmacist. However, the pharmacy is not authorized to determine the quantity; only the prescribing practitioner can decide the quantity based on the patient’s specific needs and the nature of the emergency.

Step 2: Reduce the Prescription to Writing

Per 21 CFR 1306.11(d)(2), the pharmacist must immediately reduce the oral prescription to writing and include all required information listed in 21 CFR 1306.05(a). This means that the pharmacy must obtain the below information from the practitioner and write it on the paper prescription:

Two key points:

• “Reduce to writing” means on paper, not just in your computer system. This written document will later need to be attached to the follow-up prescription.
• The practitioner must provide all required details, such as drug name, quantity, prescriber name, and DEA number. A pharmacist cannot act as the prescriber’s agent or determine missing information, such as quantity.

Step 3: Verify Practitioner Identity

Under 21 CFR 1306.11(d)(3), if the pharmacist does not personally know the prescriber, they must make a reasonable effort to confirm the oral authorization came from a DEA-registered practitioner. This may include a callback using the phone number listed in a directory or other good-faith verification methods.

Step 4: Follow-Up Requirements

Per 21 CFR 1306.11(d)(4):

• The prescriber must send a written prescription within 7 days of the oral authorization for the emergency quantity dispensed.
• The written prescription must include the phrase “Authorization for Emergency Dispensing” and the date of the oral order.
• Delivery can be in person or by mail; for LTCF patients, fax is acceptable.
• Upon receipt, the pharmacist must attach the written prescription to the original document reduced to writing.
• If the follow-up prescription is electronic, the pharmacist must annotate the record of the electronic prescription with the original authorization of the date of the oral order. This is done to link it to the original oral authorization.
• If the written prescription is not received within 7 days, the pharmacist is required to notify the DEA. Failure to report can result in losing the ability to fill emergency Schedule II prescriptions.

Conclusion

Compliance with DEA regulations for emergency Schedule II prescriptions in long-term care settings is critical to avoid severe penalties and protect patient safety. Pharmacies must ensure that emergencies meet strict criteria, prescriptions are called in directly by the prescriber, quantities are limited, documentation is accurate, and follow-up requirements are met within seven days. Adhering to these steps not only fulfills legal obligations but also promotes integrity and safeguards vulnerable patients in long-term care facilities.

Contact Brinks DEA Consulting Today

If you have any questions or concerns regarding your long-term care pharmacy’s compliance with Schedule II emergency prescriptions or need guidance on any controlled substance-related issues, we encourage you to contact Brinks DEA Consulting. Our team specializes in helping pharmacies navigate complex DEA regulations to ensure full compliance and avoid costly penalties.