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Common Errors We See in Pharmacy Inspections and How to Avoid Them

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

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), Food and Drug Administration (FDA) and the Department of Health (DOH), have the authority to inspect pharmacies.

Inspections may be routine and simply to confirm compliance with the law. Annual inspections by the Florida DOH are examples of these. However, inspections can also be triggered by a fear of imminent danger to the public health, safety, and welfare; a formal complaint; or the belief that a specific violation of law by the pharmacy or pharmacist has occurred or may occur.

Common Errors Found During Inspections.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1.  Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2.  Pharmacy technicians not supervised by pharmacist;

3.  Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4.  Controlled substances not accurately recorded on appropriate forms;

5.  Not keeping schedule II inventory and dispensing records separate from schedule III-V records;

6.  Failure to maintain a biennial inventory;

7.  Controlled substance records (including invoices, inventories and logs) not properly maintained for required number of years;

8.  Not having an accurate count for all controlled substances on hand;

9.  Required DEA forms not maintained, accurate or complete;

10.  Inadequate security measures (cameras, alarms, etc.);

11.  Failure to control access to secured areas;

12.  Proper pre-hire screenings not in place (background checks, references, etc.);

13.  Proper computer security measures not in place;

14.  Not properly identifying suspect controlled substance prescriptions;

15.  No corrective measures in place to ensure legitimacy of a controlled substance
prescription;

16.  Not knowing the requirements for filling a legitimate controlled substance
prescription;

17.  Refrigerator not being maintained at the appropriate temperature; and

18.  Food or other non medications (e.g., lab samples) being kept in refrigerator with medications.

Be Aware: All Pharmacies Are Subject to Inspections.

We are constantly writing blogs on pharmacies that, after inspections, get served with immediate suspension orders (ISO), emergency suspension orders (ESO), or have their controlled substance registrations revoked. This is not happening to just the smaller independent stores, but to the big chain pharmacies as well.

In a prior case, the DEA revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. (Click here to read that blog.) This is why it is imperative for all pharmacies and pharmacists to know the state and federal laws and regulations.

Your Best Defense.

In our opinion, your best defenses are the following:

1.  Know the laws and rules and be sure they are fully implemented and followed, always, by everyone in the store.
2.  Maintain good professional liability insurance that includes coverage for legal defense of administrative complaints and complaints against your pharmacy license and your pharmacist license.  Cover should be at least $25,000 for legal defense expenses at the very minimum. Contact Lloyd’s of London or Healthcare Providers Service Organization (HPSO) if your agent can’t locate this insurance for you.

3.  Contract with a good pharmacy consultant and have him/her make frequent visits and “mock investigations.”

Talk to an Experienced Attorney Before You Talk to an Investigator.

In Florida, you do not have any duty to cooperate with any investigator who is investigating you. This extends to DOH investigators, DEA special agents, police officers, sheriffs’ deputies or criminal investigators of any type. Our advice is to always contact an experienced health law attorney before making a statement to an investigator. Click here to read a previous blog on the best practice tips for dealing with investigators.

Never voluntary relinquish your DEA registration or your pharmacy license without speaking to an experienced health law attorney first. Click here to read a blog on why this is so important.

Contact Health Law Attorneys Experienced with Investigations of Pharmacies and Pharmacists.

The attorneys of The Health Law Firm provide legal representation to pharmacies, pharmacists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

KeyWords: Pharmacy defense lawyer, representation for pharmacies, pharmacy law defense attorney, representation for pharmacy inspections, representation for Drug Enforcement Administration (DEA), DEA investigation lawyer, DEA pharmacy investigation attorney, Food and Drug Administration (FDA) representation, FDA investigation lawyer, FDA pharmacy investigation representation, Florida Board of Pharmacy lawyer, representation for Board of Pharmacy inspections, Department of Health (DOH) representation DOH defense lawyer, DOH inspections, DOH investigators, common deficiencies in pharmacy inspection, health law defense attorney, administrative law representation,  legal defense for administrative complaints,  Florida defense attorney, Florida defense lawyer, The Health Law reviews, reviews of The Health Law Firm

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

Two More Compounding Pharmacies Recall Drugs

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.

Recall Upgraded in New Jersey.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Eye Infections from Georgia Compounding Pharmacy Products.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Florida Compounding Pharmacy in Hot Water Due to Fungal Growth.
We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Harsher Regulations on Compounding Pharmacies.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Common Deficiencies We See in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2. Pharmacy technicians not supervised by pharmacist;

3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4. Controlled substances not accurately recorded on appropriate forms; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recently blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

 

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

New Requirements Released for Physician Medical Records Related to Compounded Medications

MLS Blog Label 2By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On September 5, 2013, the Florida Board of Medicine and the Florida Board of Osteopathic Medicine published new requirements for medical record documentation related to compounded medications administered to patients in an office setting.  These standards become effective September 9, 2013. The standards are contained in Florida Administrative Code Rules adopted by each board.

We believe the updated requirements are a result of the recent recalls of tainted compounded medications that have spread across the country and infected thousands of patients. These new standards will make it easier for health care professionals to trace drug reactions and spot tainted batches of medications quickly. The new changes apply to the exact documentation required anytime a compounded medication is administered to a patient.

For the Florida Board of Medicine this is an update to Rule 64B8-9.003, Florida Administrative Code. For the Florida Board of Osteopathic Medicine this is an update to Rule 64B15-15.004, Florida Administrative Code.

New Medical Records Standards.

According to the Florida Board of Medicine and the Florida Board of Osteopathic Medicine, when compounded medications are administered to a patient in the office the medical record documentation must contain, at a minimum:

1.  The name and concentration of medication administered;
2.  The lot number of the medication administered;
3.  The expiration date of the medication administered;
4.  The name of the compounding pharmacy or manufacturer;
5.  The site of administration on the patient;
6.  The amount of medication administered; and
7.  The date the medication was administered.

New Standards Most Likely Triggered by Tainted Compounded Medications.

These new standards are being implemented about a year after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Click here to read our previous blog. Florida is no stranger to allegations of tainted compounded products. In May 2013, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

It’s likely these updated requirements are a direct result of the recent issues with compounded medications and compounding pharmacies. In the event a health care professional’s office receives a batch of tainted compounded medicine, these medical record standards will help the health care professional track which patients received the tainted medications. Also, authorities, such as the Department of Health (DOH) and U.S. Food and Drug Administration (FDA), will be able to easily track and send recalls to the offices that receive tainted compounded medications.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Had you heard of these updates? Do you think these requirements will help officials track tainted medications? Please leave any thoughtful comments below.

About the Authors: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

More Than 7,000 Patients of Oklahoma Dentist Are Being Asked to Get Tested for HIV and Hepatitis

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

The unsanitary practices of an Oklahoma dentist may have exposed more than 7,000 patients to HIV and hepatitis, according to a number of media sources and the Oklahoma Department of Health (DOH). Currently officials with the Oklahoma DOH are contacting all of the dentist’s patients since 2007, and urging them to get tested for blood-borne diseases. Since the news broke on March 28, 2013, the dentist has voluntarily closed his two offices and surrendered his dental license for 30 days.

Click here to read a copy of the letter from Oklahoma DOH warning the dentist’s patients to get tested.

We want to point out that these are just allegations made against the dentist at this point in time and have not been proven by the state.

Dentist Accused of Being a “Menace to the Public” in Complaint.

According to the complaint filed with the Oklahoma Board of Dentistry, the dentist is allegedly facing 17 allegations from The Board due to the violations against his practice.

Alleged charges against the dentist include:

1.  A patient testing positive for HIV and hepatitis C;

2.  The dental practice being unsafe, unsanitary and lacking of sterilization checks;

3.  Committing gross negligence related to decisions related to the dental health care of patients;

4.  Practicing dentistry without the proper display of licenses and certifications;

5.  Violation of provisions of the State Dental Practice Act by failing to keep a suitable record of dangerous drugs;

6.  Unlawful practices in authorizing dental assistants to practice dentistry; and

7.  Having open vials of medications and unsanitary dental materials in an unclean environment.

Click here to read the complaint.

Dentist Admitted to Not Handling Sterilization and Drugs Procedures.

According to the complaint, a device in the dentist’s office used to sterilize dental instruments wasn’t working properly. An inspector also found two separate sets of instruments. Each set was cleaned differently, one set of instruments was for patients known to have infectious diseases, and one set was for those not believed to have such diseases. Oklahoma DOH officials said the proper approach is for all instruments to be handled as if they contain viruses and infectious diseases.

According to an article in The New York Times, the dentist allegedly told officials during one inspection of his office that his staff handled all sterilization and drug procedures. Click here to read the entire article from The New York Times.

Dentist Faces Hearing at State Board of Dentistry.

According to the Oklahoma DOH, the dentist has been a state-licensed dentist since 1974, and an oral surgeon since 1977. He faces the possibility of having his license revoked, after a hearing on April 19, 2013, at the state Board of Dentistry in Oklahoma. This investigation is ongoing.

Contact Health Law Attorneys Experienced with Department of Health Investigations of Dentists.

The attorneys of The Health Law Firm provide legal representation to dentists in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at http://www.TheHealthLawFirm.com.

Comments?

What do you think of this dentist’s story? Are you curious as to how the practice got so bad? Please leave any thoughtful comments below.

Sources:

Oklahoma Board of Dentistry State of Oklahoma v. Wayne Scott Harrington, D.M.D. Case Number 13-005. Statement of Complaint. (March 28, 2013). From: http://www.thehealthlawfirm.com/uploads/OK%20Dentist%20Complaint.pdf

Ball, Brandi. “Tulsa County Dentist May Have Exposed 7,000 Patients to HIV, Hepatitis.” News on 6. (March 28, 2013). From: http://www.newson6.com/story/21820518/tulsa-county-dentist-may-have-exposed-patients-to-hiv-hepatitis

Oklahoma State Department of Health. “Tulsa Health Department, Oklahoma State Department of Health and Oklahoma Board of Dentistry Investigate Tulsa Dentist.” (March 28, 2013). From: http://bit.ly/ZwRhRT

Fernandez, Manny. “Tests Start for Patients of Dentist in Inquiry.” The New York Times. (March 29, 2013). From: http://www.nytimes.com/2013/03/30/health/dental-patients-in-oklahoma-warned-of-disease-risk.html

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.Copyright © 1996-2012 The Health Law Firm. All rights reserved.

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 reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Products from Georgia Compounding Pharmacy Allegedly Causing Eye Infections.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Franck’s Compounding Pharmacy in Florida  Caused Fungal Growth.

We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Compounding Pharmacies Under the Microscope.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding pharmacies, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Deficiencies That are Common in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2. Pharmacy technicians not supervised by pharmacist;

3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4. Controlled substances not accurately recorded on appropriate forms; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recent blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

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 as if they were contaminated as a precaution. The pharmacy has agreed to recall all of its sterile products. Click here to read the Associated Press article.

The injections in question allegedly contain the same drug at the center of the October 2012, deadly fungal meningitis outbreak. More than 55 people, including five in Florida were killed and 740 others were sickened after receiving contaminated injections from a Massachusetts compounding pharmacy. I previously blogged about that outbreak. To read more, click here.

Patients in North Carolina and Illinois Allegedly Reacted to Injections.

Federal authorities have allegedly identified seven cases of patients who have suffered complications after being injected with the potentially contaminated medications. There are five cases in Illinois and two cases in North Carolina. The Illinois patients supposedly have skin infections and one patient in North Carolina allegedly suffered from a fungal infection.

Florida Department of Health Working to Contain Allegedly Tainted Injections Statewide.

According to the Florida Department of Health (DOH), at least three Florida facilities received the drugs under investigation. Two of the facilities are in Melbourne, Florida, and one is in Chipley, Florida. The Florida DOH says it is not aware of any local cases of infections from these drugs.

To read the press release from the Florida DOH, click here.

Previous Florida Case of Contaminated Medication.

We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Congress Debating on Giving Authority Over Compounding Pharmacies to FDA.

Currently, compounding pharmacies are regulated by state pharmacy boards. There is currently legislation moving through Congress that would give the FDA direct authority over the compounding manufacturers. The goal is to prevent any national outbreaks tied to compounded medications.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sound Off.

Do you think each state should be responsible for regulating compounding pharmacies, or do you think the FDA should be responsible? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “FL Got Drugs Linked to New Outbreak.” Health News Florida. (May 24, 2013). From: http://health.wusf.usf.edu/post/fl-got-drugs-linked-new-outbreak

Kelly, Christopher. “FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections from Main Street Family Pharmacy in Tennessee.” Food and Drug Administration (May 24, 2013). From: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353941.htm

Stobbe, Mike and Loller, Travis. “FDA Warns of Infections Tied to Tennessee Pharmacy.” The Associated Press. (May 24, 2013). From: http://www.npr.org/templates/story/story.php?storyId=186473297

Florida Department of Health. “The Florida Department of Health Partners with Federal and State Health Organizations to Ward of Adverse Reactions Associated with Steroid Injections.” Florida Department of Health. (May 24, 2013). From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2013/05/052413CDCinfection.pdf

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999. 

Copyright © 1996-2012 The Health Law Firm. All rights reserved.