• 950 Boardwalk Suite 305, San Marcos, CA 92078
    • 760.705.4078
    • tvidals@rxpert.solutions

What to Expect When the DEA Comes Knocking

Rxpert Solutions > Controlled Substances > What to Expect When the DEA Comes Knocking

Pharmacy is a world filled with regulations. The U.S. Department of Justice is just one agency enforcing some of those regulations, and they can show up at your pharmacy any time to confirm you are following the regulations. Here are the basics of what they are looking for.

First, if they will always come with a minimum of two people. No DOJ agent will come alone. Second, if your pharmacy has a registration insured for controlled substance dispensing, they have the authority to inspect it. They will, however, ask for your consent. You do have the right to refuse at that moment, but make no mistake, if you do refuse inspection, they will be back.

Their inspection will consist of:

  1. Reviewing your records
    In general they want to see how you handle your business and related documents. They will confirm you do your due diligence such as vetting your suppliers or employees. They will review your biennial inventory. TIP: be sure to include whether the inventory was done at beginning or close of business.
  2. Performing an audit
    The inventory must be spot on. It is a problem whether it is short or there is overage. TIP: Know where all the drug supply is. In the words of an inspector, “it should not be a treasure map adventure”. If the audit comes up short and then you remember you have some meds stored in a back room that does not make a great impression.
  3. Reviewing storage and security
    The premises must be secure. The security needs may be differ depending on location, but you must meet the security standards of where your pharmacy is located. In other words, if you are in a high crime area you will need to show a higher level of security than a pharmacy in a lower crime area or one not street facing. You should know what you need to do to keep the place as secure as possible and you will be expected to do that. TIP: Call the local DEA if you have questions on whether you are doing enough.

One final TIP: Keep the documents you know they will ask for in a binder which is readily retrievable. It will take some pressure off and will also show them you are organized and handle your business with detail.

Our References

Terri is absolutely phenomenal. She is an incredibly knowledgeable pharmacy resource. As the medication safety officer, the quality initiatives she implemented not only impacted the patients at our medical center but also reached into the community. Terri is a genuine professional who upholds accountability while creating community among her team members. She is a great listener to identify friction points and has actionable ideas to implement improvements.

Lab
T. Eagle. MBA, MLS(ASCP), CLS Lab Operations Manager

Terri is an expert at prospective risk identification -Failure, Mode and Effects Analysis (FMEA). Terri participated in CHPSO Patient Safety Safe Tables and was part of the Hospital Quality Institute’s Regional Quality and Patient Safety Leader Network.
She is an excellent public speaker and communicates well with public and professional audiences. I look forward to her continued work in medication safety.

Regional Quality Network at HQI
A. Munoz, FACHE, CPHQ, CPPS VP

Terri has done a tremendous job with the controlled substance diversion program. She has had such a positive impact and has really made the hospital a safer place.

Tri-City Medical Center
Nurse Manager

We would not be where we are with the improvements we have made with opioid prescribing if it were not for Terri driving the process.

Tri-City Emergency Medical Group
Chief Physician

In addition to understanding the ins and outs of the [controlled substance use] process completely, she is very proactive in coming to me with provider issues that she detects. She truly balances the administrative duties and the regulatory components demand with a keen sense of what my practitioners do and what their needs are on the ground. Terri is instrumental in working with my department, balancing patient care, cooperation, ability, and integrity to get the job done.

UCSD Medical Center
Chief Anesthesiologist

Terri is knowledgeable and effective in pharmacy leadership. She has the ability to be able to anticipate and prepare for the future. Her ability to utilize resources effectively in this changing environment is a strong asset. She can adapt, evolve, mentor and still never say “no” when asked to assist. She exhibits great abilities to be flexible and is a “self starter”. She has a pleasant yet effective demeanor that commands results.

Candace Fong, Pharm D
System Director of Pharmacy and Medication Safety Common Spirit Health

Terri has always impressed me as being very smart. resourceful, creative, and easy to work with. Terri’s commitment to medication safety permeated our organization, raising the awareness of this important issue throughout all levels of the institution. Terri has always been engaged, cooperative, and generous with her time.

Cary Mells, MD
Chairman of the Department of Emergency Medicine Tri-City Medical Center

Terri has done more for the Pharmacy in her few months as Interim Pharmacy Director than any other Director has done during my 12 years here.

Anita Kennedy, MBA
VP of Ancillary Services Methodist Hospital

Contact Us

Address: 950 Boardwalk Suite 305, San Marcos, CA 92078

  • 760.705.4078
  • tvidals@rxpert.solutions