Internal theft of 36,000 oxycodone pills. Over $180 million in violations. Pharmacy technicians caught selling expired Adderall.
These are just 3 of the dozens of examples shared by Jim Schiffer, RPh, Esq. and Carlos M. Aquino during their presentation on surviving Drug Enforcement Administration (DEA) inspections during the National Community Pharmacists Association (NCPA) 2024 Annual Convention and Expo, held October 26-29 in Columbus, Ohio.1
“Look at the back of a $1 bill, it says, ‘In God We Trust.’ Those of you who are pharmacy owners, look at that dollar bill,” said Schiffer, a pharmacist-turned-lawyer and current partner at Allegaert Berger & Vogel, LLP. “That’s the only person you trust. Everyone else at the pharmacy? You’ve got to make sure they have integrity.”
Schiffer and Aquino—a former police officer, DEA Task Force sergeant, and DEA diversion investigator, who founded PharmaDiversion, LLC and currently works as a compliance consultant—have seen dozens of cases where pharmacists ended up on the wrong side of a DEA investigation. When that happens, the most crucial part of any response is to be prepared.
Under Title 21 of the Code of Federal Regulations, Part 1316, the DEA is authorized to inspect pharmacies that hold a license to distribute controlled substances. “When the DEA comes to your pharmacy and says, ‘I’m here to inspect,’ they give you a DEA Form 82; it’s consent for them to be there. Sign it,” Aquino said. “Unless you have something to hide, sign it.” If you refuse, he explained, DEA agents will return with warrants from the US Attorney’s Office—and conduct a significantly more thorough investigation.
“I know you have constitutional rights,” said Aquino. But when it comes to DEA registrations, the DEA gives it, and the DEA takes it away.
In addition to preparation and cooperation, the next most important part of a DEA investigation is remaining truthful. “Don’t lie,” said Schiffer. “Don’t lie to the DEA, or the FDA, or to the FBI, or to Homeland Security.” From Schiffer, this advice was borne of a first-hand experience: “I’m speaking to you as the attorney for someone who lied to the DEA in front of me. When all the other charges…were dropped, the Southern District of New York…said, ‘We’re going to give your client a felony for lying to us.’” That client was later forced to surrender his license as a pharmacist.
The DEA can bring 2 types of action against a pharmacy: administrative action or civil action. Administrative actions can include a Letter of Admonition, Order to Show Cause, immediate voluntary surrender of DEA registration, or immediate suspension or revocation of a pharmacist’s DEA license. Civil actions can include fines, which—as of February 12, 2024—are $18,759 for each record keeping violation and $80,850 for each prescription violation.
Although voluntary surrender of your DEA registration is an option, Aquino strongly recommends against doing so. "I don’t care if they have you down on the ground handcuffed and are saying to you, ‘If you surrender your DEA registration, we’re not going to take any actions against you,’” Aquino said. “You say, ‘No, I’m not surrendering it.’ And then you contact your attorney.” This is because if a pharmacist surrenders their DEA registration for cause, “you will never get another DEA registration,” Aquino explained. “And, most likely you’re going to lose your state pharmacist license.”
Proper record keeping is the best defense against a DEA investigation. Pharmacies’ Controlled Substance Ordering System (CSOS) can easily lead to thousands of dollars in fines for a few reasons: sharing or posting passwords, not confirming in CSOS that an order was received, no power of attorney letter, and no records of DEA form 222, which must be readily retrievable.
Addressing password sharing is perhaps the easiest fix: CSOS applications cost nothing. Rather than sharing passwords, Schiffer and Aquino recommend completing applications for every CSOS user and granting each user their own log-in information.
Form 222 can be kept either digitally or in hard copy, but Aquino recommends going the paper route. “The DEA are tree killers; they love paper,” he explained. After printing, “keep it in a binder or a folder.” That way, when DEA investigators show up, forms for the appropriate time period can be immediately retrieved. And although ready access is important, it’s equally important that those forms include proper notation: the date the drugs were received, the quantity of drugs received, and—although not required by the DEA—the initials of the individual who verified the order.
When choosing to whom might grant power of attorney, Schiffer and Aquino urged critical thinking: only grant power of attorney to someone trusted—a spouse, a grandparent, a lead pharmacy technician. “The bottom line is, you’re the owner; it’s going to fall on your shoulders," said Schiffer.
About Pseudoephedrine
Although pseudoephedrine is not a controlled substance, the DEA is responsible for enforcing the terms of the Combat Methamphetamine Epidemic Act of 2005, signed into law on March 9, 2006.2,3 This act banned the OTC sale of cold medicines containing ingredients such as pseudoephedrine, which are commonly used to make methamphetamines. Purchase of these products does not require a prescription, but the items must be stored behind the counter and there is a daily limit of 3.6 g of products that have an ephedrine base, pseudoephedrine base, or phenylpropanolamine base.
There is a yearly certificate that must be signed, acknowledging that everyone working in the pharmacy is aware of the CME. To keep the best records, use paper or electronic methods to obtain the signature of the person making the purchase, along with the time of day.
When ordering schedule III, IV, or V controlled substances—such as acetaminophen with codeine, ketamine, testosterone, alprazolam (Xanax), lorazepam (Ativan), tramadol, diphenoxylate/atropine (Lomotil), and pregabalin (Lyrica), among others—invoices must also be available for inspection. Like all form 222s, these invoices should include the date the drugs were received, the quantity of drugs received, and—again, not required by the DEA—the initials of the person who received the drugs.
Theft and Loss
Cases of theft or significant loss must be reported within 1 day of discovery. As for what constitutes significance, “everybody’s different,” Schiffer said. “If you have 20,000 tablets dispensed, and you’re short 2 [tablets]… That’s not significant in Brooklyn. If you’re short 100 or 200 [tablets], that would be significant. It’s a judgement call.”
“If you’re missing 50 tablets in a 100 count bottle, that’s significant,” said Aquino. “If you have 1 tablet missing every month, and after a while you start adding them up? That’s significant.”
When a pharmacist discovers a theft or loss, the first step should be contacting their attorney, if they have one, Aquino explained. Next, the DEA must be notified—in writing—within 1 business day. “You don’t have to give quantities,” Schiffer said. “You have to let them know that [you] discovered a loss, and [you’re] investigating to see what is missing.” Within 45 days of a theft or loss, DEA Form 106 must be submitted via the DEA Diversion website. Like invoices and form 222s, these communications must be readily retrievable for investigators.
Drug Destruction
Aquino recommends using a reverse distributor when destroying controlled substances. “Any controlled substance that you have, that’s expired unsellable, make sure you’re maintaining a perpetual inventory of what you have on hand,” he said. Using the reverse distributor option turns the pharmacist into the supplier, rather than the buyer, and requires an additional paper trail. “Make sure that you email a copy of that 222 with quantity shipped and date shipped on the invoice.”
Inventory Records
Although Title 21 of the Code of Federal Regulations, Part 1304.21(A) says that “no registrant shall be required to maintain a perpetual inventory,” Aquino pointed out that when the DEA comes knocking, shortages or overages—or, in other words, potential theft and loss or poor record keeping—can still result in fines. “Even though you’re not required to keep a perpetual inventory, do it to protect yourself,” Schiffer added.
This inventory should be exact as well—again, regardless what the Code of Federal Regulations says. For schedule I or schedule II substances, Part 1304.11(e)(6) requires an “exact count or measure of the contents;” for schedule III, IV, or V substances, an “estimated count or measure of the contents” is acceptable—unless the container “holds more than 1000 tablets or capsules,” which would require an exact count.
“You can eyeball alprazolam. You can eyeball tramadol,” Schiffer said. “But eyeballing is not an exact number. If you eyeball it wrong, and then [the DEA] comes and does a review of your records and an inventory… If those items were ones that you eyeballed wrong, it’s going to come up as a problem with your record keeping.
Due Diligence
There are 3 elements of a DEA inspection: record keeping or inventory, security of controlled substances such as the pharmacy’s alarm system and CCTV cameras, and due diligence, Aquino explained.
“My policy has always been, the pharmacy—the registrant—you have to make sure that your pharmacists are filling prescriptions for legitimate medical purposes,” Aquino said. “The pharmacist has a corresponding responsibility to determine that the prescription is written for a legitimate medical purpose by a practitioner acting in their usual course of professional practice.”
“There is no federal law or regulation that says you are obligated to fill a prescription,” Aquino said. “You don’t have to fill a prescription if you—in your mind, with your corresponding responsibilities—determine that a prescription is not for a legitimate medical purpose,” such as a radiologist—a physician with a DEA license—who writes a prescription for 180 tablets of oxycodone.
“Don’t be afraid to push back on a prescriber,” Schiffer added. “Why is this 35 year old, apparently healthy looking person getting 180 [tablets] of oxycodone, 30 milligrams, every month for 2 or 3 years, from a general practitioner? If the doctor gives you lip, you have a lip too; share it.”
If the DEA comes knocking, Schiffer added, “You’re going to be in trouble too, just like the prescriber.”
Check out the rest of our NCPA coverage here.
Coverage of the National Community Pharmacists Association 2024 Annual Convention and Expo was supported by Red Sail, with independent editorial content creation on-site by the Drug Topics team.
References
1. Schiffer JR, Aquino CM. How to survive a DEA inspection. Presented at: National Community Pharmacists Association 2024 Annual Convention and Expo; October 26-29, 2024; Columbus, Ohio.
3. General information regarding the Combat Methamphetamine Epidemic Act of 2005 [Title VII of Public Law 109-177]. Drug Enforcement Agency. Accessed October 26, 2024. https://www.deadiversion.usdoj.gov/meth/cma2005.html
