Controlled Substances Act Registrations (CSA)

What is a CSA Registration?

Controlled Substances Act (CSA) Registrations are required for any person or business that manufactures; distributes; dispenses; prescribes; conducts instructional activities, research, or chemical analysis with; or imports or exports controlled substances listed in Schedules I through V of Iowa Code chapter 124 in or into the state of Iowa, or that proposes to engage in such activities, unless exempt from registration pursuant to rule 657 IAC—10.8(124).

Every individual practitioner or researcher who administers, prescribes, stocks, or dispenses any controlled substance must be registered under both state and federal Controlled Substances Acts. Federal registration is with the Drug Enforcement Administration (DEA). State registration is with the Iowa Board of Pharmacy. These registrations must be renewed periodically; check the respective registration certificates for expiration dates. Registration certificates must be maintained at the registered location. Registration is for a specific practice location. Individual practitioners or researchers who personally procure and maintain a stock supply of controlled substances for dispensation or administration at multiple locations must obtain a separate registration for each location. Individuals who make a change in their practice location must notify both the state and federal offices.​

Who Shall Register?

To be eligible to register, individual practitioners must hold a current, active license to practice their profession. The following individuals, if procuring/stocking, prescribing, administer, or dispensing controlled substances in Iowa, are required to register:

  • Advanced Registered Nurse Practitioners (ARNP)
  • Dentists (DDS/DMD)
  • Medical Doctors (MD)
  • Optometrists (OD)
  • Osteopathic Physicians (DO)
  • Physician Assistants (PA)
  • Podiatric Physicians (DPM)
  • Veterinarians (DVM)
  • Psychologists with Prescriptive Authority
  • Researchers (Professional license not required; approved research protocol is required)

The following businesses, if engaged in any activities involving controlled substances, are required to register:

  • Manufacturers
  • Reverse Distributors
  • Outsourcing Facilities
  • Distributors
  • Importer/Exporters
  • Pharmacies
  • Hospitals (Including hospital pharmacies, jails, and animal shelters)
  • Clinics (Including outpatient surgery centers and substances use disorder clinics; not private offices of individual practitioners or groups of practitioners)
  • Narcotic/Medication Assisted Treatment Programs
  • Emergency Medical Service Programs
  • Researchers
  • Analytical Laboratories
  • Health Care Facilities (Including care facilities, group homes, and assisted living facilities)
  • Dog Training Facilities (Including privately-owned and law enforcement K-9 training programs)
  • Teaching Institutions
  • Religious Organizations

Rules: Chapter 10 Controlled Substances

Check the Status of a CSA Registration

New Applicants may check the status of their CSAR application at https://ibop.igovsolution.net/online/Lookups/Lookup_Individual.aspx. Search by License/Registration Type CSA-Individual or CSA-Business, as appropriate, and the applicant’s name. Do not enter a License/Registration number. If the status is pending approval, use the Application Status Check feature to see what information is still needed.

Existing registrants (individuals and businesses) may check the status of their CSAR at https://ibop.igovsolution.net/online/Lookups/Lookup_Individual.aspx. Search by License/Registration Type CSA-Individual or CSA-Business, as appropriate, and the registrant’s name and/or CSAR number.

Disciplinary Information: A list of licensees and registrants who have been disciplined by the Board, with links to the disciplinary documents, can be found under Public Documents.

Initial CSA Registration Instructions for Individuals

NEW APPLICANTS WITHOUT A DEA NUMBER:

STEP ONE

  • Submit the Controlled Substances Act Registration Application for Individuals either online or through the mail. Excluding researchers, an Iowa professional license is required before the state or federal controlled substance registration will be issued.
  • For the question regarding a federal DEA number, please enter "Pending" or simply leave blank.
  • Once your application has been processed, you will receive an email (from iowa@igovsolution.com) with your assigned CSA-Individual registration number and its expiration date.  At this point, the status of your CSA registration will be "Pending PMP".
    • INDIVIDUAL RESEARCHERS AND VETERINARIANS are not required to register to use the Prescription Monitoring Program (PMP). Once your initial CSAR application has been processed, your registration status will be “Current/Active” and your certificate will be mailed the following business day so that you can apply for a federal DEA registration.

STEP TWO

  • Submit your federal registration application (Form DEA-224) from the Drug Enforcement Administration (DEA), available on the DEA's website. In section 3 ("State Licenses") of the online application process you will need to enter your state CSAR number and expiration date. The number and expiration date will be found in the email you received from iowa@igovsolution.com. Researchers and veterinarians will find their CSAR number on their certificate.

STEP THREE

  • When you receive your federal DEA number, you then must apply for a free user account with the Iowa Prescription Monitoring Program (PMP).
  • You will be required to provide both your DEA number and your NPI number during the PMP registration process.
  • Once your PMP account is approved, Board of Pharmacy administrators will update the status of your CSAR from "Pending PMP" to "Current/Active" and your CSAR certificate will be mailed to you. You may also sign up for a Board of Pharmacy online profile to download/print a copy of your CSAR certificate yourself.

NEW APPLICANTS WITH A DEA NUMBER:

STEP ONE (Veterinarians and Researchers, skip to STEP TWO)

STEP TWO

  • Submit the Controlled Substances Act Registration Application for Individuals either online or through the mail. Excluding researchers, an Iowa professional license is required before the state or federal controlled substance registration will be issued.
  • For the question regarding a federal DEA number, either leave blank if you will be applying for a separate DEA number for your work in Iowa, or provide your existing DEA number if you will be transferring that number to your Iowa practice address.
  • Once your initial CSAR application has been processed, your registration status will be “Current/Active” and your certificate will be mailed the following business day so that you can apply for a new federal DEA registration or change the address on your existing DEA registration. You may also sign up for a Board of Pharmacy online profile to download/print a copy of your CSAR certificate yourself.

STEP THREE

  • If you are applying for a separate DEA registration for your work in Iowa, submit the federal registration application (Form DEA-224) from the Drug Enforcement Administration (DEA), available on the DEA's website. In section 3 ("State Licenses") of the online application process you will need to enter your state CSAR number and expiration date which will be found on your CSAR certificate.
  • Or, if you are changing the address on your existing DEA registration, you may do so on the DEA’s website as well.

STEP FOUR

  • If you have applied for a separate DEA registration for your work in Iowa, email or call (515-725-3487) Sharon Smith at the Board of Pharmacy with your new DEA number so your CSAR and Iowa PMP account can be updated.

Initial CSA Registration Instructions for Businesses

  • Pharmacies, distributors, and outsourcing facilities that are applying for their initial Iowa license may indicate on the primary license application that they will be handling controlled substances and will be issued a corresponding CSAR.

 

  • Pharmacies that already hold an Iowa license and need to apply for a CSAR may submit the new/change pharmacy application and fee and will be issued a corresponding CSAR.

 

  • Distributors and outsourcing facilities that already hold an Iowa license and need to apply for a CSAR may submit the CSAR application for businesses and will be issued a corresponding CSAR.

 

  • Other businesses that do not hold a primary license with the Board of Pharmacy (Care facilities, EMS programs, researchers, analytical laboratories, jails, animal shelters, dog training facilities, clinics, narcotic/MAT programs, teaching institutions and religious organizations) may apply for a CSAR by submitting the CSAR application for businesses.

 

CSA Registration Renewal Instructions

  • Individuals and businesses may sign up for an online profile to renew their CSAR at https://ibop.igovsolution.net/online/User_login.aspx.
    • ​Renewals may be completed in the online profile beginning 60 days prior to expiration and up to four months after expiration. Penalties and disciplinary sanctions may apply if you do not timely renew your registration.
    • Registration renewal is the registrant's responsibility. As a courtesy, the board office sends a renewal notice to each registrant at least 60 days prior to expiration. The renewal notice is sent via email to the registrant’s last known email address. Failure of the registrant to receive the notice does not relieve the registrant of responsibility for renewing that registration prior to its expiration. A registration can be renewed online or by paper application.
  • Paper applications for both individuals and businesses can be found at https://pharmacy.iowa.gov/application-forms. These applications must be submitted to the Board of Pharmacy office with a check or money order.

CSA-Individual Registration Expiration Date Conversion and Fees

On April 27th, 2020, the Iowa Board of Pharmacy began the process of converting Controlled Substances Act (CSA) Individual registration expiration dates to match the professional license expiration date of the practitioner when the practitioner renews his/her registration online.

The practitioner must provide his/her professional license number and expiration date in the Board of Pharmacy online profile so when the practitioner submits the online CSA renewal, the CSA registration expiration date will match with the professional license expiration date. This may mean a practitioner will need to renew the CSA registration again in a few months. If the expiration date of the professional license is less than 180 days from the current CSA expiration, the practitioner will not be charged a renewal fee for that short renewal period. In the future, the professional license must be renewed before a practitioner will be permitted to renew his/her CSA registration.

The CSA renewal fee is $45 per year so the conversion fees are as follows:

Initial Renewal Term with Conversion         Fee for Converted Expiration

1 - 179 days from current expiration date     $0

180 - 366 days from current expiration         $45

367 - 731 days from current expiration         $90

732 - 1096 days from current expiration       $135

1097 - 1461 days from current expiration     $180

1462 - 1826 days from current expiration     $225

1827 - 2191 days from current expiration     $270

At this time, renewal applications submitted through the mail will be renewed on the same two-year schedule as in the past. Individual researchers’ CSA registrations will be renewed on the same two-year schedule as well.

 

CSA Registration Applications

Initial/Reactivation Applications

  • Initial and reactivation (expired for more than 4 months) CSA applications for individual practitioners and researchers are now available online.
  • Initial online applications for business will be available in the future.
  • Paper applications for both individuals and businesses can be found at https://pharmacy.iowa.gov/application-forms.

Renewal Applications

  • Renewal CSA applications for current/active registrations or registrations that expired less than 4 months ago for individuals and businesses may be submitted online.
  • Paper applications for both individuals and businesses can be found at https://pharmacy.iowa.gov/application-forms.

Fees

  • Refer to the appropriate application for more information regarding fees.

CSA Registration Changes

  • Individual practitioners or researchers may submit changes to their address, contact information, registered drug schedules, etc. online. Name changes may be submitted through the Board of Pharmacy Name Change Form and must be accompanied by a legal name change document or a copy of their updated professional license.
    • Changes to your CSAR must be processed before you contact the DEA to make subsequent changes to your DEA registration.
  • Businesses may submit limited changes to their registration through their online profile.
    • The following businesses with no Board of Pharmacy primary license shall submit the CSA-Business application (https://pharmacy.iowa.gov/application-forms) and fee for DBA name changes and/or location changes:
      • Care Facilities
      • EMS Programs
      • Teaching Institutions
      • Religious Organizations
      • Clinics
      • Jails (Fee exempt)
      • Animal Shelters
      • Dog Training Programs (Fee exempt if law enforcement)
      • Narcotic/Medication Assisted Treatment Programs
      • Researchers
      • Analytical Laboratories
    • The following businesses that hold a primary license with the Board of Pharmacy shall submit the appropriate primary license change application (https://pharmacy.iowa.gov/application-forms) and fee for changes to the business name, location, ownership, pharmacist-in-charge, or facility manager, as applicable:
      • Distributors and manufacturers
      • Pharmacies (including hospital pharmacies)
      • Outsourcing Facilities

Controlled Substance Inventory

Federal and state laws require all controlled substances registrants to inventory all stocks of controlled substances in the possession of the registrant on the date the registrant first engages in the manufacture, distribution, dispensing, administration, prescribing, or disposing of controlled substances. In the event the registrant commences business or practice with no controlled substances on hand, that fact shall be recorded as the initial inventory. After the initial inventory, a registrant shall take a new inventory every year. The annual inventory may be taken on any date that is within one year of the previous inventory.

A pharmacy located in Iowa that dispenses controlled substances listed in Schedule II of the Controlled Substances Act shall maintain a perpetual inventory system for each of those substances. Specific requirements for maintenance and periodic reconciliation of the perpetual inventory are found in Board rule 657 IAC--10.33(124,155A). See 657 IAC chapter 10.

All inventories shall be taken either as of opening for business or as of the close of business on the inventory date and the inventory record shall identify either “opening” or “close of business.” The person making the inventory record shall date and sign the bottom of the final page and shall initial and date the bottom of all other pages of the inventory record. The inventory record shall be maintained in written, typewritten, or electronically printed form at the registered location two years from the date of the inventory. An inventory record of substances listed in Schedule I or Schedule II of the Controlled Substances Act shall be maintained separately from an inventory of all other controlled substances.

Inventory records of controlled substances shall include the name of the substance, the strength and dosage form of the substance (e.g. 10 mg. tablet), and the quantity of the substance. If the substance is listed in Schedule I or Schedule II of the Controlled Substances Act and for all solid oral and injectable hydrocodone-containing products, an exact count or measure of the contents shall be recorded. For all other substances listed in Schedules III, IV or V of the Controlled Substances Act, if the container has been opened, the registrant may make an estimated count or measure of the substance unless the original unopened container held more than 100 tablets or capsules, in which case an exact count shall be recorded.

It is the responsibility of both the current owner and the prospective owner to take an inventory of all controlled substances whenever there is a change in ownership of an establishment licensed by the Board. An owner may delegate the actual taking of such inventory.

It is the responsibility of the owner to take an inventory of all controlled substances whenever there is a change in the responsible individual or the pharmacist in charge, as appropriate, of any establishment licensed by the Board.

If you need additional information regarding these procedures, please contact Terry Witkowski or contact the compliance officer assigned to your area of the state.

Controlled Substance Disposal

Any person or business registered to handle controlled substances in Iowa shall dispose of such drugs as follows:

  1. The responsible person shall contact and utilize the services of a DEA-registered and Iowa-licensed disposal firm (reverse distributor) OR
  2. The responsible person may contact the assigned compliance officer for their county for assistance or direction regarding the disposal of the drugs.

Disposal of Resource Conservation and Recovery Act (RCRA) hazardous pharmaceutical waste:

The U.S. Environmental Protection Agency (EPA) has identified the following controlled substances to be hazardous pharmaceutical waste:

  • Chloral hydrate
  • Diazepam gel / injectable
  • Fentanyl spray
  • Phenobarbital
  • Testosterone gel / injectable

In order to be exempt from the EPA regulations for disposal of these substances, the waste must be disposed of in a manner that is publicly deemed in writing as acceptable by DEA or by incineration. To date, DEA has not publicly deemed in writing that any particular method of disposal meets its non-retrievable standard; as such, this hazardous pharmaceutical waste must be disposed of via incineration.

Disposal of controlled substances from long-term care facility patients:

Controlled substances dispensed to a resident in a long-term care facility and subsequently requiring destruction due to discontinuance of the medication, death of the resident, or other reasons necessitating destruction shall be destroyed by one of the following methods:

  1. In facilities staffed by one or more persons licensed to administer medications, controlled substances may be destroyed by a licensed healthcare professional (pharmacist, registered nurse, licensed practical nurse) in witness of one other responsible adult.  The professional destroying or otherwise disposing of the medication shall prepare and maintain a readily retrievable record of the destruction or other disposition which shall be clearly marked to indicate the destruction or other disposition of resident medications.  The record shall include, at a minimum, the following:
    • Resident's name;
    • The name, strength, and dosage form of the substance;
    • The quantity destroyed or otherwise disposed;
    • The date the substance is destroyed or disposed;
    • The signature or uniquely-identifying initials or other unique identification of the professional and the witness.
  2. Via a DEA-compliant collection receptacle for controlled substances located within the facility. A pharmacy which has modified its registration with DEA to be an authorized collector may install and manage a collection receptacle at a LTCF, pursuant to federal regulations.

Summary of Drugs and Schedules

Schedule I (1)

Includes drugs with no proven or acceptable medical use and a high abuse potential - authorized research only.

Schedule II Narcotic (2)

Includes narcotic drugs with a high potential for abuse but with currently accepted medical use in treatment. (Opiates, cocaine, methadone, meperidine, oxycodone, morphine, hydrocodone, fentanyl)

Schedule II Non-Narcotic (2N)

Includes non-narcotic drugs with a high potential for abuse but with currently accepted medical use in treatment. (Amphetamines, phenmetrazine, pentobarbital, methylphenidate, and short-acting barbiturates)

Schedule III Narcotic (3)

Includes narcotics in combination with other non-narcotic drugs, such as codeine combined with acetaminophen or aspirin, buprenorphine.

Schedule III Non-Narcotic (3N)

Non-narcotics including ketamine, anabolic steroids, and central nervous system depressants, such as glutethimide, methyprylon, and barbiturates not listed in other schedules. Also includes anorectant agents not included in other schedules.

Schedule IV (4)

Includes narcotics in combination with other non-narcotic drugs, antidiarrheals, mild CNS depressants, mild CNS stimulants, and tranquilizers. Drugs such as chloral hydrate, meprobamate, phenobarbital, diphenoxylate with atropine sulfate, chlordiazepoxide, diazepam, carisoprodol, midazolam, alprazolam, and phentermine are in this group.

Schedule V (5)

Includes narcotic cough syrups and ephedrine, pseudoephedrine, and phenylpropanolamine products.

Additional Information

All controlled substances require a properly executed prescription electronically prepared, signed, and transmitted pursuant to DEA requirements for electronic prescribing of controlled substances in compliance with 657 IAC--10.24.

In a situation when an oral order is not permitted or when a prescriber is unable to prepare and transmit an electronic prescription in compliance with DEA requirements for electronic prescriptions, a prescription may be written in compliance with 657 IAC--10.24.

A prescriber may ask an assistant to write or type the prescription or to prepare an electronic prescription but the prescriber is responsible for ensuring that all information is correct and the prescriber must manually or electronically sign the prescription, as appropriate.

For more information, see 657 IAC Chapter 10 - Controlled Substances.

Printed from the Iowa Board of Pharmacy website on July 30, 2021 at 1:09pm.