Showing posts with label DEA. Show all posts
Showing posts with label DEA. Show all posts

Thursday, December 12, 2013

Naugatuck Pharmacy, Nelson's Pharmacy Accused of Violating Federal Law; The pharmacy will pay a hefty fine to resolve allegations made by the federal government. - Patch.com 11 December 2013, 1:56 pm



Naugatuck Pharmacy Accused of Violating Federal Law
Patch.com
The allegations against Nelson's Pharmacy, at 153 Maple St., include the failure to insure that prescriptions it filled contained an authorized practitioner's DEA number, and the failure to account for accurate inventories of Oxycodone 10 mg. tablets ...

continue to read here

Wednesday, February 13, 2013

March DEA Conference on Preventing Drug Diversion Open to Pharmacy Personnel in New Mexico


From the NABP found here

 
Drug Enforcement Administration (DEA) is offering two regional one-day Pharmacy Diversion Awareness Conferences in Albuquerque, NM, one on Saturday, March 2, 2013, and another on Sunday, March 3, 2013. Each one-day conference is open to pharmacy personnel (pharmacists, pharmacy technicians, or loss prevention personnel) who are employed by pharmacies or hospitals/clinics that are registered with DEA in the state of New Mexico. The conference is designed to assist pharmacy personnel in identifying and responding to potential diversion activity. Location details, a conference agenda, and a link to the online registration form are available in a DEA notice. There is no registration fee for these conferences. Upon completion of the one-day conference, pharmacists and pharmacy technicians will receive 7 continuing pharmacy education hours (0.7 CEUs). 

Saturday, February 9, 2013

The U.S. Drug Enforcement Adminis­tration is releasing few details into why agents raided Wagoner Medical Centers on Thursday in Carroll and Howard counties.


The U.S. Drug Enforcement Adminis­tration is releasing few details into why agents raided Wagoner Medical Centers on Thursday in Carroll and Howard counties.
Owen Putnam, a DEA public information officer, would confirm only that “we were there Thursday.”
The website for Wagoner Medical Center states that it was founded in 1965 in Burlington by doctors Don Wagoner and Marilyn Wagoner, who are husband and wife.
Don Wagoner practices at the Burlington office; his wife is based at the Kokomo location.
The centers focus on family medicine, and employees include three physicians and three physician assistants, according to the website.
The DEA is responsible for enforcing the federal Controlled Substances Act, which regulates the manufacture, distribution, importation and possession of certain substances.
Controlled substances are categorized by ingredients into five categories.
Continue to read here

Wednesday, February 6, 2013

Friday, January 4, 2013

DEA Proposes New Regulations to Dispose of Unwanted Prescription Drugs

http://ncadd-middlesex.blogspot.com/ is reporting the following:

The Drug Enforcement Administration (DEA) has proposed new regulations to give the public more options for disposing of unwanted prescription drugs, such as painkillers and sedatives. The new rules are designed to reduce the amount of highly abused prescription drugs on the streets, the Orlando Sentinel reports. The DEA wants law enforcement agencies and pharmacies to maintain collection boxes for certain medications. The agency also recommends implementing mail-back programs to safely dispose of the drugs. Under the proposed rules, for the first time, groups outside of law enforcement would be allowed to collect unused drugs for disposal, the article notes. According to a DEA news release, the proposal would allow authorized retail pharmacies to voluntarily maintain collection boxes at long-term care facilities. The DEA also calls for continued use of prescription drug “take-back” events. The public can comment on the proposed regulations until February 19. Congress subsequently will vote on the measure.

 

Tuesday, October 23, 2012

Rep. Markey Letter To Department of Justice to Investigate New England Compounding Center, and to Probe into DEA’s Past Oversight of Pharmaceutical Compounding

On October 22, 2012, the FDA Blog has a post written by By Karla L. Palmer & Larry K. Houck, which addresses Representative Markey's Letter to the Department of Justice as it relates to the DEA.  The blog post provides in part:
The letter notes that almost 1,000 specific formulations of recalled NECC drug products contain controlled substances such as cocaine, morphine, hydromorphone, meperidine, sufentanil, fentanyl and ketamine. (All of these substances are schedule II substances except for ketamine, which is a schedule III substance).

Sunday, August 19, 2012

DEA has announced approved certifying organizations to enable e-prescribing of controlled substances


On August 1, 2012, the DEA announced that it has approved the certification processes for controlled substances e-prescribing systems that have been developed by Drummond Group and iBeta LLC, and that current approvals are posted on the DEA website. Approval of the certification process is the final regulatory step at the federal level to allow CSA e-prescribing, but please notes that some states have yet to modify their statutes to allow for e-prescribing, particularly of Schedule II drugs. [DOJ, DEA, Docket No. DEA-364, Electronic prescriptions for controlled substances: notice of approved certification processes. 77 Fed. Reg. 45688-45689, August 1, 2012;http://1.usa.gov/NSLMro].

Tuesday, August 7, 2012

DEA Administrative Actions in 2012

The Department of Justice, Drug Enforcement Agency has taken the following administrative actions against doctors and pharmacies during 2012: 
The list can be found here.

Saturday, July 28, 2012

"Office Use" in Tennessee: Does this Apply to Compounded Drugs?


This article appeared in the Tennessee Board of Pharmacy January 2012 newsletter, which is found here:

Understanding the Correct Transfer for ‘Office Use’
Pharmacists have often asked how to follow the proper procedures
when transferring a medication to another pharmacy
or prescribing practitioner. Please note that the only place in
the Tennessee Board of Pharmacy rules that mentions “office
use” is in Rule 1140-06-.02 (5), which states “ . . . A nuclear
pharmacy practice site may also furnish radiopharmaceuticals
for office use to authorized practitioners for individual patient
use . . . ”
Therefore, what is allowed? Refer to Tennessee Board of
Pharmacy Rule 1140-09-.01, which states:
“ . . . (3) The requirement of a license [referring to a
Manufacturer/Wholesaler license] shall not apply to
the following types of distributions . . . [*](i) The sale,
purchase or trade of a prescription drug, or an offer
to sell, purchase or trade of a prescription drug by a
pharmacy practice site to another pharmacy practice
site or to authorized prescribing practitioners, except
that the total gross dollar volume of such transfers
shall not exceed five percent (5%) of the total medical and
prescription orders sales revenue of either the
transferor or transferee pharmacy during any twelve
(12) consecutive month period . . . ”
Therefore, instead of transferring pursuant to a prescription
for “office use only,” pharmacists are advised to invoice
the medication or medical device while complying with section (i),
and hold this readily retrievable record for two years.
In this manner, the medication can then be delivered to the
prescribing practitioner’s office or pharmacy.
Furthermore, the rules change/add when dealing with a
controlled substance. For a Schedule II medication, Drug
Enforcement Administration (DEA) Form 222 must be
completed between the seller and buyer, while one copy is
kept in the pharmacy for two years per Title 21, Code of
Federal Regulations (CFR) 1307.11, which may be found at
the following Web link: www.deadiversion.usdoj.gov/21cfr/
cfr/1307/1307_11.htm. An invoice with the following information
must also be kept for Scheduled III through V medication
including the name, address, and DEA registration number of
both parties, the name, strength, quantity, and dosage form of
the drugs, and the date of the transaction, pursuant to CFR
1304.22. CFR 1304.22 may be found at the following Web
link: www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_22.
htm. It is advised to obtain a signature of each registrant
on the invoice. This record must be kept for two years per
DEA CFR 1304.04., found at the following Web link: www
.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_04.htm.
According to CFR 1307.11, the pharmacy must make certain
that the distribution “. . . does not exceed 5% of total dosage
units of controlled drugs dispensed and distributed during the
same calendar year unless licensed as a distributor by DEA .
. . ” This regulation is in addition to the Tennessee Board of
Pharmacy rule stated previously, which refers to 5% of total
order sales revenue. (See asterisked section of Rule 1140-
09-.01 referenced at the beginning of this article.)

Thursday, July 5, 2012

Federal Investigation Takes Down New Breed of Pill Mills in Florida

DEA Press Release 

June 27 – (Vero Beach, FL) – Seven doctors and seven clinic owners, which included two firemen were charged on state racketeering violations spanning across Florida. This morning’s operation dubbed “Operation Pill Street Blues” was announced by Mark R. Trouville, Special Agent in Charge of the Drug Enforcement Administration, Miami Field Division; Pam Bondi, Attorney General of Florida, Deryl Loar, Sheriff, Indian River County Sheriff’s Office; David Currey, Chief, Vero Beach Police Department, and Dr. John H. Armstrong, Surgeon General, Department of Health. The arrests come following a two year investigation led by the DEA in conjunction with the Indian River County Sheriff’s Office, Vero Beach Police Department, and the Attorney General’s Office of Statewide Prosecution.

The defendants charged are: Lewis Gabriel Stouffer (32/Coconut Creek), Craig Louis Turturo (32/Boca Raton), Bruce Paul Karlin (63/Delray Beach), Courtland Burr Twyman (38/Deerfield Beach), Jeffrey Clark Thompson (32/Pompano Beach), Dale Andrew Gatlin (59/Jacksonville), Jeffrey J. Reiter (54/Fort Pierce), Dr. Bruce Jay Kammerman (54/Palm City), Dr. Susan Helen Yandle (48/Jacksonville), Dr. Fernando Valle (58/Orlando), Dr. Roger Lee Gordon (65/Plantation), Dr. Joseph Patrick Buffalino (64/Sarasota), Dr. Sanjay Trivedi (49/St. Johns), Dr. Michael Charles Bengala (67/Pompano Beach).

These defendants are facing 144 violations of Florida statutes which include the following offenses: racketeering; conspiracy to commit racketeering; manslaughter; trafficking in a controlled substance; conspiracy to traffic in a controlled substance (28 grams or more); delivery of a controlled substance; illegally prescribing a controlled substance by a practitioner; illegally prescribing a controlled substance (oxycodone hydrochloride) by a practitioner-trafficking amount; workers compensation fraud; and money laundering.

Today’s operation resulted in the arrest of 12 defendants. Bruce Karlin and Courtland Twyman are expected to surrender within 24 hours. In addition, approximately 59 bank accounts were seized totaling approximately $1.1 million, and 13 search warrants have been executed in nine jurisdictions including seven search warrants on clinics at the following locations:

Stuart Pain Management, 1146 21st Street; Vero Beach, Southern Back & Spine, 424 N. Peninsula Drive, Daytona Beach; Jacksonville Back & Spine, 1845 University Blvd., N Jacksonville; Gainesville Health & Wellness, 7731 W Newberry Road, Gainesville; Sarasota Pain Management, 5580 Bee Ridge Road, Sarasota; Miami Dade Medical Solutions; 1021 Ives Dairy Road, Miami; and Sunset Pharmacy (AIW) 4224 Cleveland Avenue, Fort Myers.

This investigation began in May 2010 when law enforcement responded to numerous community concerns regarding suspicious activities at the Stuart Pain Management in Vero Beach, Florida. During the investigation, agents traced Stuart Pain Management and eight other clinics, which spanned from Pensacola to Miami, Florida, to an organization headed by Lewis Stouffer. During the investigation, agents also learned that Stouffer and his partner Craig Turturo are active Pompano Beach Firemen.

The investigation further revealed Stouffer used his business sense to research public records relating to past DEA investigations such as Operation Pill Nation and Operation Oxy Alley in order to avoid law enforcement scrutiny. Stouffer used his hero firefighter/paramedic image, to maneuver through the system. Stouffer maintained a rapport with local law enforcement. He educated his co-conspirators on how to successfully report their competition as well as how to report doctor shoppers in order to appear as though they were legitimate pain clinics. All the while, Stouffer was receiving a “tribute” or percentage of the clinic’s income for his services as “the brains of the operation.” While Stouffer’s efforts give the resemblance of legitimacy, his drug enterprise had just one purpose: to make money from illegal drug trafficking and the financing of illegal drug trafficking throughout Florida.

The Stouffer drug trafficking organization is responsible for diversion of millions of narcotic medications, including Oxycodone, Roxicodone, Percocet, Xanax, MS Contin, and Valium throughout Florida. Doctors were recruited by the Stouffer organization to prescribe the medically unnecessary narcotics to doctor shoppers. Many of their “patients” were addicts and abused the prescriptions while others sold the drugs on the street for profit. As a result, Stouffer and his partners have made millions of dollars from the operation of their illegal drug network.

The investigation involved the use of judicial wire intercepts, informants, and under cover visits to clinics that spanned from Pensacola to Miami, Florida. The undercover agents visited each of the seven doctors charged and were prescribed approximately 2,732 oxycodone tablets without medical justification.

Between July 2011 and June 2012, conversations were judicially intercepted between the members of this drug trafficking organization. The calls revealed how Stouffer would instruct his pain clinic managers on how to detect undercover agents, and how they refer to some of their doctors as “serial killers” and referred to their patients as “junkies.” Karlin and Gatlin joked about a doctor, who worked at Stuart Pain Management, being “high on drugs” and being “a prescription addict like our patients.” The calls revealed they had no remorse for their patients’ deaths. For example, on or about March 8, 2012, Karlin called Stouffer to tell him about the death of Forrest Cyphers, a patient of Dr. Gordon at Stuart Pain Management. During the call, Stouffer told him not to worry as “people die every day.” Dr. Gordon and Karlin are being charged with Manslaughter for the death of Forrest Cyphers.

The seven doctors charged are responsible for dispensing over two million Oxycodone 30 milligram tablets within a single year. Each doctor will be served an Immediate Suspension Orders (ISO) by the DEA, which suspends their ability to prescribe, dispense, and administer any controlled substance. The table below is a breakdown of the number of Oxycodone 30 milligram tablets that were prescribed by the doctors in the Stouffer organization.





Prescribing Doctors

Quantity


Bruce Kammerman

644,266


SusanYandle

506,184 (9 mos)


Fernando Valle

430,899


Roger Gordon

271,140


Michael Bengala

126,808 (4 mos)


Sanjay Trivedi

98,822


Joseph Buffalino

67,084 (7 mos)


Total

2,145,203




This investigation is ongoing. Additional arrests of co-conspirators are forthcoming, to include doctors and others.

SAC Trouville commended the Department of Health on their assistance in this investigation relating to Emergency Suspension Orders of medical and business licenses for these rouge doctors and pain clinics.

This investigation was conducted by the DEA, Indian River County Sheriff’s Office and Vero Beach Police Department, with assistance from the Attorney General’s Civil and Medicaid Fraud Divisions, the Agency for Health Care Administration, Alachua County Sheriff’s Office, Broward County Sheriff’s Office, Daytona Beach Police Department, Escambia County Sheriff’s Office, Florida Department of Financial Services, Florida Department of Health, Florida Department of Law Enforcement, Florida Division of Insurance Fraud, Ft. Pierce Police Department, Gainesville Police Department, Highlands County Sheriff’s Office, Hillsborough County Sheriff’s Office, Internal Revenue Service, Jacksonville Sheriff’s Office, Manatee County Sheriff’s Office, Miami-Dade Police Department, Palm Beach County Sheriff’s Office, Port St. Lucie Police Department, Sarasota County Sheriff’s Office, Sebastian Police Department, Tampa Police Department, Volusia County Sheriff’s Office, and North Florida High Intensity Drug Trafficking Area.

This investigation is being prosecuted by the Attorney General’s Office of Statewide Prosecution and the State Attorney’s Office 19 th Judicial Circuit.

The charging document is merely an accusation and the defendants are assumed innocent unless and until proven guilty.

Federal Pill Mill Investigation Results in Multiple Arrests in Florida


The National Association of  Boards of Pharmacy is reporting:

A multi-agency operation has resulted in charges against seven doctors and seven clinic owners on state racketeering violations related to the operation of illegal pain clinics throughout Florida. Drug Enforcement Administration (DEA) reports that the defendants “face 144 violations of Florida statutes which include the following offenses: racketeering; conspiracy to commit racketeering; manslaughter; trafficking in a controlled substance; conspiracy to traffic in a controlled substance (28 grams or more); delivery of a controlled substance; illegally prescribing a controlled substance by a practitioner; illegally prescribing a controlled substance (oxycodone hydrochloride) by a practitioner-trafficking amount; workers compensation fraud; and money laundering.” As of June 27, 2012, 12 of the defendants had been arrested, and approximately 59 bank accounts were seized totaling approximately $1.1 million. Further, DEA notes that 13 search warrants have been executed in nine jurisdictions including search warrants on clinics. 

Numerous community concerns regarding suspicious activities at the Stuart Pain Management, Vero Beach, FL, initiated an investigation in May 2012. Agents discovered that Stuart Pain Management and eight other clinics throughout Florida were operated by an organization headed by Lewis Stouffer. Stouffer and his partner Craig Turturo are active Pompano Beach firemen. According to DEA, “Stouffer used his hero firefighter/paramedic image, to maneuver through the system. Stouffer maintained a rapport with local law enforcement. He educated his co-conspirators on how to successfully report their competition as well as how to report doctor shoppers in order to appear as though they were legitimate pain clinics. . . The Stouffer drug trafficking organization is responsible for diversion of millions of narcotic medications, including Oxycodone, Roxicodone, Percocet, Xanax, MS Contin, and Valium throughout Florida.”

Additional details about the investigation and charges are available in a DEA news release. This investigation is ongoing and is being prosecuted by the Attorney General’s Office of Statewide Prosecution and the State Attorney’s Office 19th Judicial Circuit. DEA notes that the charging document is merely an accusation and the defendants are assumed innocent unless and until proven guilty.


This article can be found here.

Tuesday, July 3, 2012

Bath Salts Compounds Are An Evolving Problem For DEA


This article is from NPR and can be found here.
June 30, 2012
One night a little more than two years ago, a 24-year-old man was rushed into the emergency room at Tulane University Medical Center in Louisiana. He was extremely agitated and hallucinating.
Dr. Corey Hebert figured the man was on drugs, probably PCP or a stimulant. But a few minutes later, the man became paranoid.
"He started doing some self-mutilating actions [and] was pulling out his eyebrows and eyelashes," Hebert tells weekends on All Things Considered host Laura Sullivan.
There's no legitimate use for these particular compounds that we know of.
Hebert then thought maybe the patient had taken methamphetamine, but his symptoms changed again. Even more surprising, a drug scan of the patient showed up clean. Hebert and his colleagues were puzzled.
After talking to the man's friends, Hebert learned he had taken a new drug that goes by the street name "bath salts."
In the months that followed, Hebert's emergency room became ground zero for bath salts patients. Every few days another patient arrived. Soon emergency rooms nationwide began seeing them, too.
The synthetic drug's popularity has been growing. National poison control centers had 304 calls about bath salts in 2010, nearly a third of them from Louisiana. Last year, there were more than 6,000 calls.
'We're Playing Whack-A-Mole'
The problem is that bath salts — which have nothing to do with the crystals you'd put in your tub — aren't one kind of drug or something you can test for and treat.
Unlike a drug like cocaine, which is made with a natural process, bath salts are made in a lab and constantly changing. The drug is designed specifically to skirt the law and test the bounds of new chemicals — with often deadly results.
"Cocaine is cocaine ... all the time, and it's always illegal," says Jill Head, a senior forensic chemist with the Drug Enforcement Agency. "But these products are continuously changing ... so what we see this week can be very different from what we're going to see a month from now."
This is a problem for police, prosecutors and the DEA, which is trying to track what the drugs are and where they come from.
Making matters worse, the compounds in the drugs aren't necessarily illegal. Because the components keep changing, drug makers can stay one step ahead of law enforcement. Even on a rush basis, it can take months to get a compound banned as a controlled substance. The DEA has gotten three compounds put on the list so far, but the agency's chemists have identified more than 60 in the past two years.
"Basically, we're playing whack-a-mole," says Arthur Berrier, a senior research chemist for the DEA. "They make one drug ... or one compound, and we smack it down, and the next week, something else pops up."
Now the scientists at a DEA lab in Northern Virginia are doing something unusual: They're making their own bath salts.
Berrier tells Sullivan that in order to fully identify a compound, scientists need what is called standard material, or an authenticated drug with a known structure.
"So typically what we would do is if we identify something in a bath salt material, we'd have to have a standard [to compare it to] to really identify it," he says.
The compounds scientists are finding are generally legal compounds not specifically controlled by the DEA, Berrier says. They show up in gas stations, pipe shops and all over the Internet as plant food, incense, hookah cleaner and, of course, bath salts.
Berrier says sometimes store owners know that what they're selling is really drugs, but sometimes they don't. The key for drug seekers is small packaging and the phrase "not for human consumption," which is supposed to hint at the opposite.
"[But] there's no legitimate use for these particular compounds that we know of," Berrier says.
Legal Difficulties
What DEA chemists are doing in beakers, bath salt makers are doing in vats. Officials believe many of those facilities are in China, India and Pakistan. Producers ship the drugs in bulk to the U.S., where officials suspect the final mixing and packaging is done.
To try to bring criminal cases against suppliers, sellers and users of what are essentially legal compounds, the DEA and prosecutors have had to reach way down into the annals of the nation's drug laws.
DEA lab director Jeff Comparin tells Sullivan that the challenge is that if a substance is not specifically listed in Title 21 of U.S. Code, which governs food and drugs, it can be classified as legal — but there's a loophole.
"Because of the nature of the structure, the way the chemicals are designed, the controlled-substances act also has a clause called the 'analog' part, where we can try these chemicals as if they were a controlled substance," Comparin says.
That means the agency can try to show the user or supplier intended to ingest or sell the product as a drug — usually through circumstantial evidence. Comparin says the DEA has successfully prosecuted some analog cases.
This trend of synthetic drugs is new and developing, Comparin says, and it's hard to say how long it will last.
"Who's to say what effect the ultimate control of these chemicals will have on their continued manufacture, importation and trafficking in the U.S.?" he says. "But as you can see right now, we just detect the new compounds and address the threat as best we can."
Just this week, Congress moved to ban more of the compounds the DEA's lab has identified. In the meantime, officials are hoping users will realize that if scientists in the nation's drug lab can't keep up with what drug manufacturers are making, users shouldn't be so sure what they're getting.