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 whopersonallyprocure 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.
Back to topWho 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
See657 IAC Chapter 10 - Controlled Substances
Check the Status of a CSA Registration
New Applicantsmay check the status of their CSAR application athttps://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 theApplication Status Checkfeature to see what information is still needed.
Existing registrants (individuals and businesses)may check the status of their CSAR athttps://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.
Back to topInitial CSA Registration Instructions for Individuals
New Applicants without a DEA Number
Step 1
- Submit the Controlled Substances Act Registration Application for Individuals either online or through the mail. Applications are found under the CSA Registration Applications and Forms header below. 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, simply leave blank.
- Once your application has been processed, you will receive an email from iowa@igovsolution.net with your assigned CSA-Individual registrationnumber and its expiration date. At this point, the status of your CSA registration will be "Pending PMP".
- INDIVIDUAL RESEARCHERS AND VETERINARIANSare 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 emailed to you so that you can apply for a federal DEA registration.
Step 2
- Submit your federal registration application (Form DEA-224) from the Drug Enforcement Administration (DEA), available on theDEA's website. In section 3 ("State Licenses") ofthe online application process you will need to enter your state CSARnumber and expiration date. The number and expiration date will be found in the email you received from iowa@igovsolution.net.Researchers and veterinarians will find their CSAR number on their certificate.
Step 3
- When you receive your federal DEA number, you thenmustapply for a free user account with theIowa Prescription Monitoring Program (PMP).
- You will be required to provide both your DEA number and your NPI number during the PMPregistration process.
- Once your PMPaccount is approved, Board of Pharmacy administrators will update the status of your CSARfrom "Pending PMP" to "Current/Active" and your CSARcertificate will be emailed to you.You may also sign up for a Board of Pharmacyonline profileto download/print a copy of your CSAR certificate yourself.
New Applicants with a DEA Number:
Step 1
Veterinarians and Researchers, skip to STEP TWO
- Apply for a free user account with theIowa Prescription Monitoring Program (PMP).
- You will be required to provide both your DEA number and yourNPInumber during thePMPregistration process.
Step 2
- Submit the Controlled Substances Act Registration Application for Individuals either online or through the mail, applications are found under the CSA Registration Applications and Forms header below. 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 emailed to you 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 Pharmacyonline profileto download/print a copy of your CSAR certificate yourself.
Step 3
- 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 theDEA's website. In section 3 ("State Licenses") ofthe online application process you will need to enter your state CSARnumber 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 theDEA’s websiteas well.
Step 4
- If you have applied for a separate DEA registration for your work in Iowa,emailor 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 facilitiesthat 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 licenseand 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 licenseand 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.
- Refer to CSA Registration Applications and Forms belowfor the most up-to-date applications.
CSA Registration Renewal Instructions
- Individuals and businesses may sign up for an online profile to renew their CSAR athttps://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'sresponsibility. As a courtesy, the board office sends a renewal notice to each registrant beginning 60 days prior to expiration. The renewal notice is sent via email to the registrant’s last known email address. Failure of the registrantto receive the notice does not relieve the registrantof responsibility for renewing that registrationprior to its expiration. A registrationcan be renewed online or by paper application.
- Paper applications for both individuals and businesses can be found at below under CSA Registration Applications and Forms.These applications must be submitted to the Board of Pharmacy office with a check or money order.
CSA Registration Changes
- Individual practitioners or researchersmay submit changes to their address, contact information, registered drug schedules, etc.online. Name changes may be submitted through theBoard of Pharmacy Name Change Formand 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.
- Businessesmay submit limited changes to their registration through theironline profile.
- The following businesses with no Board of Pharmacy primary license shall submit the CSA-Business application 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
- For the above businesses only: To update the responsible individual, the new responsible individual must submit a request to Board staff in writing which includes the following information: 1) Registered business' name and address; 2) CSA registration number; 3) Their full name and title; 4) Effective date of the change.
- The following businesses with no Board of Pharmacy primary license shall submit the CSA-Business application and fee for DBA name changes and/or location changes:
- The following businesses that hold a primary license with the Board of Pharmacy shall submit the appropriate primary license change application 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). See657 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. An exact count shall be recorded for all substances, unless it is a liquid in a non-incremented container which can be estimated to the nearest quarter container.
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 contactTerry Witkowskior contact thecompliance officerassigned to your area of the state.
Back to topControlled Substance Disposal
Any person or business registered to handle controlled substances in Iowa shall dispose of such drugs as follows:
- The responsible person shall contact and utilize the services of a DEA-registered and Iowa-licensed disposal firm (reverse distributor)OR
- The responsible person may contact theassigned compliance officer for their countyfor 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:
- 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.
- 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.
CSA Registration Applications and Forms
All application fees are nonrefundable and nontransferable. Once an application is submitted and the fee is paid, the withdrawal of an application, determination of ineligibility based on prior criminal convictions, or discovery of the submission of an incorrect application type does not merit return or refund of the application fee. Do not submit an application if you are unsure of which application type to submit.Do not send cash.
Online Applications
- Initial/Reactivation Controlled Substances Act Registration Application for Individual Practitioners or Researchers(Application for initial applicants or to reactivate an expired registration)
- Controlled Substances Act Registration Application for Individual Practitioners or Researchers(Renewal for current/active registrations or registrations that expired less than four months ago)
Paper Applications
- Controlled Substances Act Registration Application for Individual Practitioners or Researchers
- Controlled Substances Act Registration Application for Businesses
Forms
- Initial Fee Waiver Application
- Individual Licensee/Registrant Notification of Name Change(online)
