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Controlled Substances Tips

Related Information

Forms

Contacts

Registration tips
You may not need an SUA.
State of Wisconsin Licensed Practitioners, (e.g. MDs, DVMs etc.) who already hold an approved DEA registration, may conduct research and instructional activities with the controlled substances for which the DEA registration was granted if:

  1. the practitioner license is current and active and,
  2. the research is conducted in the same location (building) that is listed as the registered address on the DEA registration and,
  3. the substances to be used for research are already authorized on the current approved DEA registration.
    If any of the above specifications are not met, an SUA must be obtained and a separate DEA registration may also be required.

General tips
Electronic records are acceptable as long as they cannot be altered or deleted and are easily separated from all other events.

To avoid a DEA citation:

  1. ensure your federally required records are complete and accurate.
  2. maintain these records separately from all other records.
    (i.e. controlled substance records must not be comingled with records of noncontrolled substances)
  3. further maintain Schedule I & II and DEA Form 222 records separately from Schedule III-V records.
    Keep one folder for schedule I & II records, one folder for Schedule III, IV & V records, and one folder for DEA Form 222 used and unused forms.

Inventory reports
Once an inventory is completed it should be documented and filed away. Do not write on it again.

Controlled substances awaiting disposal must be included in your inventory as long as they remain in your possession.

When determining the number of units remaining in a container that has been opened:

  1. schedule I & II substances require an exact count or measurement.
  2. schedule III-V substances can be estimated unless the container holds more than 1000 tablets or capsules.

Invoices, receipts, and packing slips
If your financial and shipping records comprise a packing slip, invoice, and/or a receipt, EACH document must contain ALL of the required information:

  1. see RARC's recordkeeping guidance.

DEA FORM 222
Keep both used and unused forms in a securely locked area.
DEA recommends:

  1. treating these forms as if they are controlled substances.
  2. making a list of your unique form numbers along with the date each form is used.
    Copy 3 (blue) of each executed DEA Form 222 must be retained and completed in full, including the number of packages received and date received.

Never throw away unexecuted DEA Forms 222. Return unwanted, defective or unused forms to DEA headquarters at the address listed in the instructions section on the back of the form.

Order paper versions of DEA Form 222 with your initial DEA application or through the Office of Diversion Control or submit forms electronically by enrolling in the Controlled Substance Ordering System (CSOS) program.

To fill out form:

  1. follow the instructions on the back of the form VERY carefully. If the form has even the slightest error, the vendor may send it back to you.
  2. Do NOT sign a DEA Form 222 before it is completed. This form is the equivalent of a prescription pad for which you are legally responsible.

Visit the DEA Office of Diversion Control Questions & Answers page for more information.

Administration/dispensing logs
Be sure to note any drug waste or insignificant loss (e.g. a minor spill or substance remaining in a vial that cannot be further utilized). This includes waste in the hub of the needle.

When determining the amount of solution lost in the hub of a needle, provide an estimation that is accurate as possible. The average needle hub may waste anywhere from 0.02 mL to 0.1mL of solution, depending on the needle type and size.

Provide a witness to waste whenever possible. DEA strongly recommends doing so.

Loss or theft reports
You must provide a written report of any instance of theft or significant loss of your controlled substances to the DEA Milwaukee District Office within one business day of discovery and submit DEA Form 106

  1. send your report via mail or fax first.
    Milwaukee District Office
    4725 West Electric Ave
    West Milwaukee, WI 53219-1627
    Diversion phone: (414) 336-7370
    Diversion fax: (414) 727-5454
    Jurisdiction: Wisconsin
  2. then complete and submit DEA Form 106 to the Milwaukee District Office and retain a copy in your records.
    DEA also recommends reporting any instance of loss or theft to local police.

Ordering
After placing an order, closely monitor its arrival. Once the shipment arrives keep it in your possession or maintain it in a secure area until it can be transported to your lock box for proper storage. Transfer the shipment to proper storage as soon as possible.

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