Controlled Substances - DEA

Question 1

What are DEA Licensure Requirements?

Answer 1

Form 224 (Renewal: 224a)

Question 2

Who Must Apply to DEA?

Answer 2

DEA Pharmacist Manual - New Pharmacy Registration:
* DEA # for Every Pharmacy Dispensing Controlled Substances
* Multiple DEA #’s if You Own Multiple Pharmacies Dispening Controlled Substances

Effective July 1, 2023 - Board May Issue DEA # To A Business Location Not Listed (Case by Case Basis):
* If Impractical To Have All Practitioners Administering/Dispensing Controlled Substances - Separately Register At Business Location
* Examples May Include:
1) Ambulatory Surgical Centers
2) Dialysis Centers
3) Federally Qualified Health Centers
4) Standalone Clinics Associated w/ Hospital System

Question 3

DEA Application Requirements?

Answer 3

1) Follow DEA Pharmacist Manual - New Pharmacy Registration
2) Complete DEA Form 224:
* ID - Valid SSN or TIN
* Business Activity
* Drug Schedules Handles (CII-CV)
* State License(s)
* Liability
* Certification of Application Fee Exemption
* Fee Method of Payment (non-refundable)
* Applicant’s Signature

Question 4

When Does DEA # Have an X?

Answer 4

January 2023: DATA Waiver Removed (X-Waiver) for Opioid Use Disorder Treament:
* Removed X from DEA #’s & Patient Caps
* Current DEA # + CIII Authority - Can Now Prescribe Buprenorphine for Opioid Use Disorder
* Previously Denoted Prescribing CIII-CV’s for Maintenace and Detoxiciation Treatment

Question 5

How Do You Validate a DEA Number?

Answer 5

2 Letters Followed By 7 Numbers

First Letter
* A, B, F, G: Full Practictioner (X was Buprenorphine)
Note: “G” = DOD Personal Service Contractors: NOW “G” + Current 1st Letter (A, B, or F)
* M: Mid-Level Practicitioner
* P, R: Manufacturer, Disributor, Researcher, Analytical Lab, Importer, Exporter, Reverse Distributor, NTP

Second Letter
* First Letter of Prescriber’s Last Name

Math for 7 Numbers
1) Add ODD (1st + 3rd + 5th) Numbers
2) Add EVEN (2nd + 4th + 6th) Numbers (x 2)
3) Add Together: LAST DIGIT Equals 7th DEA #

Equations:
* (1st + 3rd + 5th) + [(2nd + 4th +6th) x 2] = Last Digit Matches 7th DEA #
* (ADDED ODDS) + [(ADDED EVENS) x 2] = Last Digit Matches 7th DEA #

Question 6

What is Required for Electronic Use?

Answer 6

DEA-Certified Prescription Application & Automated Data Processing System

Question 7

DEA Renewal Cost? Frequency?

Answer 7

Iowa CSA: $90 every 2 years (biennium)
* May Include Nonrefundable Fee Surcharge (No More than 25%) For Deposit into Program Fund
* May Renew Up to 60 Days Prior to Expiration

Waived:
* Federal, State, & Law Enforcement Agencies
* Federal & State Institutions
(hospitals, teaching institutions, analytical laboratories)

Question 8

DEA License Update Process?

Answer 8

Modifications via Registration Renewal Application: Up to 60 Days Prior-4 Months After Expiration Date
* Submitted 60+ Days PRIOR to Exp. Date: Continue to Service Iowa Patients While Pending
* Submitted 30-60 Days PRIOR to Exp. Date:
$90 Late Fee + $90 Application Fee
* Submitted 31+ Days AFTER Exp. Date:
$360 Late Fee (Reactivation Application/Fee?)

Question 9

DEA Reinstatement Process?

Answer 9

Registration Reactivation Application:
* $360 Reactivation Fee (nonrefundable)
* Disclosure of controlled substance activities conducted while registration was expired.

Question 10

When to Use DEA Forms? (222, 41, 106)

Answer 10

Form 222: Ordering
Ordering Controlled Substances

Form 106: Theft/Loss
Theft or Loss of Controlled Substances

Form 41: Destroyed
Registrant Record of Controlled Substances Destroyed

Question 11

Required Information on DEA Invoices?

Answer 11

• Record Rx’s Actual Receipt Date
  (by pharmacist or other responsible entity)
• Invoices Kept for 2 Years