Section 6.2: DEA Registration & Texas Controlled Substances Act

Section 6.2: DEA Registration & Texas Controlled Substances Act

The Necessity of Registration: Who Must Register?

To prevent the diversion of controlled substances, the federal government and state regulators maintain a closed system of distribution. Every person or entity that manufactures, distributes, dispenses, prescribes, conducts research with, imports, or exports controlled substances must register with the Drug Enforcement Administration (DEA). A registration is specific to a person or entity and a physical location; a registrant cannot operate at multiple locations under a single registration unless authorized.

In the context of pharmacy practice, it is crucial to understand that pharmacies must register with the DEA as dispensers. Individual pharmacists employed by a registered pharmacy do not need their own DEA registration to dispense controlled substances. The pharmacy itself holds the DEA registration (as a "dispenser"), and the pharmacists act as agents of the pharmacy when performing their duties. However, individual practitioners (such as physicians, dentists, veterinarians, podiatrists, and qualified mid-level practitioners) who write prescriptions for controlled substances must obtain their own individual DEA registrations.

DEA Registration Classifications & Forms

The DEA utilizes specific forms for registration and renewal:

1. DEA Form 224: This form is the application for new registration for retail pharmacies, hospitals, clinics, practitioners, and teaching institutions.
2. DEA Form 224a: This form is used for the renewal of a DEA registration for retail pharmacies, hospitals, clinics, practitioners, and teaching institutions. The registration must be renewed every three years.
3. DEA Form 224b: This is a retail pharmacy registration affiliate renewal form, which allows chain pharmacy corporations to submit a single, consolidated renewal form for all their registered retail locations, rather than filing separate forms for each location.
4. DEA Form 225: This form is the application for new registration for manufacturers, distributors, researchers, analytical laboratories, importers, and exporters.
5. DEA Form 225a: This form is used for the renewal of registrations for manufacturers, distributors, researchers, and other non-practitioner entities. These registrations must be renewed annually.

The Dissolution of Texas DPS Registration

Historically, Texas required a dual registration system for controlled substances. Registrants had to obtain a federal DEA registration AND a separate state controlled substances registration from the Texas Department of Public Safety (DPS). However, on September 1, 2016, the Texas Legislature officially abolished the DPS controlled substances registration program.

• Current Texas Rule: Today, a pharmacy or practitioner in Texas does not need to apply for or maintain a separate state-level controlled substance registration.
• The Requirements: To lawfully handle controlled substances in Texas now, a pharmacy or practitioner only needs:
  1. An active, unrestricted state professional license (e.g., a pharmacy license issued by the TSBP, or a medical license issued by the Texas Medical Board).
  2. An active federal DEA registration.
• Eliminating the DPS registration simplified the administrative burden, but it means that the TSBP and other licensing boards directly monitor compliance with controlled substance laws during routine inspections and disciplinary actions.

DEA Number Structure and Validation Math

A DEA registration number is a unique nine-character identifier consisting of two letters followed by seven digits. Pharmacists have a corresponding responsibility to ensure that any controlled substance prescription they dispense has a valid DEA number.

• First Letter (Registrant Type):
  • A, B, F, G: Used for hospital, clinic, practitioner, and retail pharmacy registrants.
  • M: Used for mid-level practitioners (PAs, APRNs, optometric glaucoma specialists, etc.).
  • P, R: Used for distributors.
• Second Letter: This letter is typically the first letter of the registrant's last name or the first letter of a business entity's name. If the business name begins with a number, the second character may be a number.
• The Validation Algorithm:
  1. Add the first, third, and fifth digits together: Sum 1 = Digit 1 + Digit 3 + Digit 5.
  2. Add the second, fourth, and sixth digits together: Sum 2 = Digit 2 + Digit 4 + Digit 6.
  3. Multiply Sum 2 by 2: Product = Sum 2 * 2.
  4. Add Sum 1 and Product together: Total = Sum 1 + Product.
  5. The last digit of the Total must match the ninth digit (the check digit) of the DEA number.
• Example: Validating DEA Number FM1234563:
  • Sum 1 = 1 + 3 + 5 = 9.
  • Sum 2 = 2 + 4 + 6 = 12.
  • Product = 12 * 2 = 24.
  • Total = 9 + 24 = 33.
  • The last digit of 33 is 3, which matches the ninth digit of the DEA number. The number is mathematically valid.

Mid-Level Practitioner (MLP) Prescriptive Authority in Texas

In Texas, Mid-Level Practitioners (MLPs) include Advanced Practice Registered Nurses (APRNs) and Physician Assistants (PAs). Under the Texas Occupations Code and TSBP rules, APRNs and PAs can prescribe controlled substances under a delegating physician's supervision, governed by a Prescriptive Authority Agreement (PAA) or facility protocol. However, their authority is subject to significant restrictions compared to fully licensed physicians.

Schedule II Prescribing Restrictions for APRNs and PAs

In general, APRNs and PAs are prohibited from prescribing Schedule II controlled substances in Texas. However, there are two primary exceptions:

1. Hospital Facility-Based Practice: An APRN or PA may prescribe a Schedule II controlled substance if the prescription is issued in a hospital facility-based practice under a delegating protocol, and the patient has been admitted to the hospital for an intended length of stay of 24 hours or greater, or is receiving care in the hospital's emergency department.
2. Hospice Care: An APRN or PA may prescribe a Schedule II controlled substance for a patient who is determined to be terminally ill and is receiving hospice care from a certified hospice provider.

Quantity Limits and Refill Restrictions for MLPs

When prescribing Schedule III, IV, or V controlled substances, APRNs and PAs have full authority to prescribe, but the total quantity prescribed, including any refills, cannot exceed a 90-day supply. For example, a PA cannot write a prescription for a Schedule IV substance (like Xanax) with a 30-day supply and 5 refills (which would equal a 180-day supply). The maximum allowable quantity is 90 days total. Furthermore, the delegating physician's name, address, telephone number, and DEA number, as well as the MLP's name, address, telephone number, and DEA number, must be clearly indicated on the face of the prescription.

Exam Traps & Mid-Level Practitioner Pitfalls

1. The 90-Day Supply Trap: A common exam question will present a prescription written by a PA for a Schedule III drug (e.g., Tylenol #3) for a 30-day supply with 3 refills. A 30-day supply with 3 refills equals a 120-day total supply. This is illegal in Texas because it exceeds the 90-day limit for MLPs. The pharmacist must refuse to fill the prescription in that quantity and consult the prescriber.
2. The Out-of-State MLP Trap: While Texas allows Texas-licensed PAs and APRNs to prescribe CIII-CV controlled substances (and CIIs under exceptions), Texas does NOT recognize controlled substance prescriptions written by out-of-state mid-level practitioners. Under Texas law, a pharmacist cannot fill a controlled substance prescription written by an out-of-state PA or APRN, even if it is valid in their home state. Only controlled substance prescriptions from out-of-state physicians (MD/DO/DDS/DVM) are eligible for filling in Texas, subject to specific out-of-state rules.