Food and Drug Administration (FDA) Recalls Products from Two Different Compounding Pharmacies

CCS Blog LabelBy Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Two different compounding pharmacies have recently recalled products due to concerns from the Food and Drug Administration (FDA). The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013.

The recalls were issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths.

All Products from Med Prep Consulting Recalled.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital […]

Negligence Will Determine the Success or Failure of the Meningitis Lawsuits Against Doctors and Clinics

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The victims and survivors of the meningitis outbreak are now filing lawsuits against the physicians and clinics that administered the tainted steroids. According to an article in The Tennessean, on January 29, 2013, a husband who lost his wife to fungal meningitis filed the first lawsuit against a Nashville outpatient clinic. It’s believed hundreds of people were injected at the same clinic with the tainted steroids. The man is now seeking $12.5 million in damages.

Click here to read the entire article from The Tennessean.

This lawsuit is just one in what is expected to be a series of lawsuits, in not just Tennessee, but across the country.

Compounding Pharmacy Allegedly Behind the Meningitis Outbreak is Out of Business.

The meningitis outbreak was at a peak in […]

Recall Alert: FDA Warns Steroid Injections Compounded by Tennessee Pharmacy May Be Contaminated

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The U.S. Food and Drug Administration (FDA) sent out a warning to health care professionals that steroid injections compounded by Main Street Family Pharmacy, LLC, in Tennessee, may be contaminated. The announcement came on May 24, 2013. So far, seven patients have allegedly suffered adverse reactions from the medications. The FDA says it is working with the Centers for Disease Control and Prevention (CDC) and the Tennessee Board of Pharmacy to investigate. The steroid injections were allegedly sent to 13 states, including Florida.

To read the press release from the FDA, click here.

Steroid Injections Recalled.

According to an article in the Associated Press, officials have not yet confirmed the products are contaminated. The FDA is treating all sterile products from Main Street Family Pharmacy […]

CVS Blacklists Second Set of Doctors Accused of Overprescribing Painkillers

1 Indest-2008-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

CVS is again stepping up its own internal efforts to combat the nation’s prescription drug abuse epidemic. According to Reuters, the second largest retail pharmacy chain announced it is cutting off access to the most powerful painkillers for more than 36 doctors and health care providers around the country. The Drug Enforcement Administration (DEA) has been keeping a close eye on CVS over the past few years. According to Reuters, CVS began revoking the dispensing privileges of certain providers back in 2011. CVS disclosed this round of suspensions on August 21, 2013.

To read the article from Reuters, click here.

CVS Closely Analyzed Prescription Practices of Health Care Providers Before Suspending Dispensing Privileges.

CVS said the suspension followed an analysis of prescriptions brought to its drugstores […]

Pharmacists: Talk to a Lawyer Before You Talk to an Investigator

By Christopher E. Brown, J.D.

In Florida, You DO NOT Have to Speak to an Investigator!

Despite mailing out hundreds of thousands of postcards and letters to pharmacists, throughout Florida, we continue to receive calls from new clients and from potential clients, after they have already spoken to and made critical harmful admissions against their own interests to investigators. In Florida, you do not have any duty to cooperate with any investigator who is investigating you. This extends to Department of Health (DOH) investigators (who are sometimes titled “Medical Quality Assurance Investigators” or “Medical Malpractice Investigators”), Drug Enforcement Administration (DEA) special agents, police officers, sheriff’s deputies, or criminal investigators of any type.

The Investigator is NOT Your Friend.

Let me state this as succinctly and clearly as possible. If you are being investigated, you will not be better off making a […]

Two Central Florida CVS Pharmacies Get Controlled Substance Licenses Pulled by Drug Enforcement Administration (DEA)

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The U.S. Drug Enforcement Administration (DEA) revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida, on September 12, 2012, according to a number of sources. The two pharmacies will no longer be able to fill prescriptions for drugs such as oxycodone, Dilaudid, Vicodin, Ritalin and Xanax. This decision is in response to a government crackdown on the distribution of painkillers. Sanford is in Seminole County, a suburb of the greater Orlando area.

To see the court records from this case, click here.

We’ve been following this story and previously blogged on this topic in our blogs on February 10, 2012, February 29, 2012, and March […]

CVS Has Allegedly Been Refilling Prescriptions and Submitting Insurance Claims Without Patients’ Permission

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) has reportedly launched an investigation into CVS’ practice for refilling prescriptions. According to an article in the Los Angeles Times, authorities are looking into reports that CVS has been refilling prescriptions and submitting insurance claims without patients’ permission. The Los Angeles Times article, released October 12, 2012, names an official with knowledge of this matter as the source.

We want to emphasize that this is from an unconfirmed news story. The government rarely announces investigations of specific subjects ahead of time.

Click here to read the entire article from the Los Angeles Times.

CVS Has Not Been Notified of Prescription Refill Investigation.

A related article in Reuters states that […]

Walgreens Files a Petition to Lift the Immediate Suspension Order

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

There’s a firefight brewing between Walgreens and the Drug Enforcement Administration (DEA). On October 10, 2012, Walgreens filed a petition asking a federal judge to lift the Immediate Suspension Order (ISO) that bans its distribution center in Jupiter, Florida, from shipping controlled substances to its stores in Florida and on the East Coast.

Back on September 14, 2012, the DEA issued an ISO on the distribution center, calling it an “imminent danger” to the public. Click here to read a blog I previously wrote when the DEA issued the ISO.

Walgreens Claims the DEA Ignored Relevant Information.

In its petition, Walgreens claims the DEA ignored and “conspicuously omitted” recent and relevant information in its ISO. The pharmacy said […]

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