Westchase pharmacy a victim of Florida's pill mill war

— With its national certification, its clean rooms and emphasis on non-narcotic medications, the Westchase Compounding Pharmacy is an unlikely casualty in the state’s war on pill mills.

Yet that’s what seemingly happened last month when Drug Enforcement Agency investigators made a surprise visit. Accompanied by federal marshals, they seized 11 boxes of controlled substances and deactivated the pharmacy’s DEA registration that allows the business to sell certain drugs and deal with private medical insurance.

“It was shocking to us,” said Virgil Valdes Jr., the chief operating officer of the pharmacy, which employees 50 people locally and dozens more around the country. “It took us by surprise. We’ve always been in compliance with the DEA and their strict regulations.”

After the business was hobbled, if not shut down by the raid, the company’s attorneys went to court and persuaded U.S. District Judge Mary Scriven to issue a temporary restraining order against the DEA. Scriven was astonished by the actions of the agency, which she said failed to follow the law and its own procedures. She called the situation “preposterous.”

The parties were scheduled to return to court last week to discuss whether the restraining order should be made permanent. The hearing was canceled, though, when the company’s suit against the DEA was settled.

As part of the settlement, the DEA agreed to permanently reinstate the pharmacy’s registration as long as it continues to follow the law.

A DEA spokeswoman declined comment for this story.

The government argued in court that the DEA registration had ceased because the pharmacy was sold, and the new owner had not followed procedures to become registered. The pharmacy approved the sale of a membership interest on Feb. 1 by Stephen M. Caddick to Renier Gobea, according to legal filings.

Attorneys for the pharmacy argued, and Scriven agreed, that the DEA was not allowed to stop the business from operating without notice unless there was a finding of imminent danger to the public, which was not made in this case. They also argued successfully that the registration belonged to the corporation, RS Compounding, and not Caddick or Gobea. And the sale had been a transfer of stock, which did not affect the registration.

“It was a gross misunderstanding,” Valdes said. “The judge sided on our behalf and we look forward to working with the DEA on compliance.”

Under the settlement, the pharmacy agreed to drop its lawsuit and not to seek any money from the DEA to compensate the company for the seized medications, lost business or legal fees. The DEA, in return, backed down from its position about the registration. The agency agreed not to take any action against the business’ registration on the basis of the transfer of ownership.

Gobea said the business had paid about $50,000 for the seized medications, which he said had a potential retail value of more than $1 million after compounding. He estimated another $20,000 was spent on legal costs, and the business lost $500,000 in sales for the days after the registration was deactivated and before the restraining order was issued.

He said settling the lawsuit without seeking money was “an easier resolution than to fight this 8,000-pound gorilla.” He said he was concerned about the employees who earn their livelihood there.

The DEA, Gobea said, has the ability to enter into an almost endless fight. “You don’t want to get into a shouting match with them because at the end of the day, they have unlimited resources. They can make your life miserable.”

Valdes said he understands why the DEA is aggressive in its enforcement of the law. “Quite frankly, I think the regulations are there for a reason, he said. “You’ve got to understand that in Florida, there’s a problem with pharmacies.

“They have to make sure the pharmacies are not being owned by mob and stuff like that. I could see how they could overreact, especially in the pharmacy, because their duty is to protect the public, right? I can’t get upset about the strict regulations, but I think what they need to do is really take one pharmacy at a time and really go through an administrative process, which obviously they didn’t do.”

Chief Pharmacist Silas Raymond said he was shocked when the agents appeared that day because the pharmacy had undergone a routine, surprise inspection in September, and it had gone well. “One of the agents complimented me on how well the paperwork was in order,” Raymond said.

During that visit, however, Gobea said agents questioned him in his office about the sale. They told him he couldn’t operate the pharmacy without the DEA approving the change in registration.

Gobea said he offered to apply on the spot for a registration in his name but was told that it could take up to a year, and the business couldn’t operate in the meantime. He said that didn’t make any sense, that someone, for example, who owned a pharmacy for 40 years couldn’t sell the business and retire without letting it close for a year while the new owners went through the process. Gobea said he emailed the agents a copy of the sale contract.

The agents left, only to return Nov. 13.

Although there were more agents, and some had guns and tactical gear, Raymond said the Nov. 13 visit went much the same as other inspections. The agents reviewed paperwork, asked questions and operated according to a plan. “The only difference is what the net result was,” Raymond said.

“It’s always scary when you have the gun-carrying law enforcement coming in,” Valdes said. “It’s always frightening when you see federal agents come in through the door, but we knew we were right and it’s not like we were hiding anything.”

Raymond said other compounding pharmacies and patients have reached out in support of the pharmacy.

Local physicians vouched for the professionalism of the pharmacy.

“From what I understand, the DEA was completely in the wrong,” said one, Frank Demery, who is board certified in internal medicine and pediatrics. “Westchase Compounding was completely in the right.”

Demery said the fact the pharmacy is accredited by the Pharmacy Compounding Accreditation Board means it meets the highest standards and is subject to inspections for quality control. “They’ve always treated my patients with great care,” he said.

Karl Metzger, who practices family medicine, said he was surprised when he heard about the action taken by the DEA “because they’re known as a quality pharmacy.”

“When I heard the news, I was a little bit confused,” Metzger said. “I was relieved to hear it was basically kind of a mistake.”

He said there is “no comparison at all” between Westchase and pill mills.

Raymond said by compounding – mixing medications especially for certain needs – the pharmacy is able to help people who are at their wits end. For example, he said a mother, who happens to work as a nurse practitioner, called because the quick-dissolving medication her daughter took for Attention Deficit Hyperactivity Disorder had been discontinued. The child wasn’t taking available alternatives.

Raymond said he was able to devise a quick-dissolving gummy that the child took. The mother, he said, was elated.

Coincidentally, he said, that mother returned for a prescription refill the day the pharmacy’s DEA registration was reactivated.

Raymond said the pharmacy fills about 200 to 220 prescriptions a day, compared to what he said would be typical for another “good, stable, compounding pharmacy,” or about 45 to 50 prescriptions daily.

The pharmacy, which Raymond said is licensed in about 30 other states, also fills a lot of mail order prescriptions.

Gobea, who grew up in Tampa, said he started the business as an investor with Caddick in 2004. Gobea said he had started working in an Eckerd Drug Store as a teen, working first as a clerk and later as a pharmacy technician.

He said he started working for a pharmacy that gave him the opportunity to get into marketing. In 2000, he started his own pharmacy business, that sold to nursing homes and correctional facilities.

Caddick, his friend, went to pharmacy school, and came to work for Gobea, Gobea said. He said Caddick’s passion was compounding, and so the two started RS Compounding, for Renier and Stephen.

Gobea said he wasn’t that interested in compounding at the time, and so he sold his share to Caddick and started working with other pharmacy interests. Eventually, he returned and bought Caddick’s interest in RS Compounding.



Twitter: @ElaineTBO

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Westchase pharmacy a victim of Florida's pill mill war
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