Selling Tobacco Can Get You Penalized By Insurance Panels

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

Beware: selling cigarettes could burn a hole in your pocket.

The CVS Health Corporation (CVS), the nation’s second-largest drug store, is currently in the midst of launching a tobacco-free prescription-drug network. The company announced in October 2014, that it will begin offering a tobacco-free pharmacy plan to employers, unions, and insurance companies for which its Caremark arm manages prescription benefits. CVS is slapping patients with an extra co-payment “penalty” if they purchase their medications from pharmacies that sell tobacco products, regardless of whether the patient is a tobacco user.

According to US News, by adding a variable co-payment of up to $15, CVS hopes that this new strategy, comparable to a narrow network insurance design, will perpetuate the company’s health-and-wellness based initiatives.

The new network will start in 2015. Customers will receive a list of participating pharmacies before any network change will take place.

Click here to read more from US News.

The Tobacco-Free Retail Trend.

Target and CVS have become the poster children for tobacco-free retailers. In 1996, Target spearheaded the fight against tobacco by eliminating all sales of the toxic substance. In September 2014, the CVS Corporation followed suit and completed its tobacco-free overhaul by removing all tobacco products from store shelves across the nation.

The tobacco-free pharmacy networks would include CVS and Target nationally, as well as local or regional pharmacies such as independent pharmacies that abstain from tobacco sales. Walgreens and Walmart pharmacies, two large-scale rival drug chains that sell tobacco, as well as any other grocery or community pharmacy, should expect patient penalties and negative impacts on prescription-drug revenue.

Those Participating in the Tobacco-Free Network.

According to Yahoo! Finance, CVS representatives said the network was created in a response to pharmacy benefit management (PBM) clients that indicated interest in tobacco-free pharmacies. The tobacco-free network will only be used by the PBM customers that voluntarily participate.

The first employer to sign on is the city of Philadelphia, as it promotes a tobacco-free workforce. Philadelphia officials estimate that between 150 and 200 CVS pharmacies will participate in the Philadelphia network.

To read more on this topic from Yahoo! Finance, click here.

Sincere Motives or a Monopoly in the Making?

There are a myriad of arguments regarding CVS’ genuine motive behind the tobacco-free network. Health benefit analysts argue that the network is a disguised anti-competition scheme. With the announcement of the new network plan, CVS opens itself up to criticism for appearing to steer patients to CVS pharmacies, or strong arm the competition into giving up lucrative tobacco revenue. Although the corporation denies these claims of ulterior motives, Dave Balto, a former policy director at the U.S. Federal Trade Commission argued that “…It’s really another effort to limit the ability of their rivals to effectively compete.”

Independent pharmacies are also questioning the industry benefits of such a plan. Small, local pharmacies that have not carried tobacco products for years may be overlooked by the consumers knowingly aware of CVS as a tobacco-free drug store. These mom-and-pop pharmacies will be forced to spend a pretty penny on increased marketing to stand on their own two feet against these mass retail chains.

The Narrow Network Comparison.

Many critics argue that the new CVS plan could be considered a narrow network strategy. A narrow network applies to any health insurance plan that places constraints on doctors and hospitals that are available to their beneficiaries. Typically plans will not cover medical services received out-of-network or they will increase co-payments.

These designs are becoming more common for insurance companies and pharmacy benefit managers. By limiting the choices, insurers say they can better focus on the quality of medical care that is delivered to plan customers.

Comments?

What is your opinion of the new CVS tobacco-free network plan? Do you think it will be beneficial for overall community health or more detrimental to the livelihood of small pharmacies? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, 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 http://www.TheHealthLawFirm.com.

Sources:

Silverman, Ed and Ziobro, Paul. “CVS Plays Hardball with Rival Drug Chains.” (October 20, 2014). From: http://finance.yahoo.com/news/cvs-plays-hardball-rival-drug-231400764.html

Murphy, Tom. “CVS Health Stretches Anti-tobacco Push to New Prescription Drug Network.” (October 21, 2014). From: http://www.usnews.com/news/business/articles/2014/10/21/cvs-develops-tobacco-free-prescription-network

About the Author: Lance O. Leider 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, Florida 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 © 1996-2014 The Health Law Firm. All rights reserved.

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Florida Board of Pharmacy Updates Record Retention Rules for Pharmacies

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

At its meeting held on February 12, 2014, the Florida Board of Pharmacy voted to approve language changes to a number of rules. Specifically, those changes were put into effect to establish a uniform four-year retention policy for pharmacy records.

Previously the Board’s rules were not consistent with respect to how long pharmacies were required to retain different types of records.

When approving new rules or changes to existing rules, administrative bodies are required to evaluate the regulatory costs of the changes. In examining these costs the Board found that any financial costs imposed upon small businesses would be balanced by the efficiencies created by a uniform retention period.

Board of Pharmacy Voted to Change the Wording in These Rules.

Below is a list of the administrative rules that were changed:

– Standards for the Approval of Registered Pharmacy Technician Training Programs
Rule 64B16-26.351, Florida Administrative Code

– Standards for Approval of Courses and Providers
Rule 64B16-26.601, Florida Administrative Code

– Continuing Education Records Requirements
Rule 64B16-26.603, Florida Administrative Code

– General Terms and Conditions to be Followed by a Pharmacist When Ordering and Dispensing Approved Medicinal Drug Products
Rule 64B16-27.210, Florida Administrative Code

– Standards of Practice – Continuous Quality Improvement Program
Rule 64B16-27.300, Florida Administrative Code

– Requirement for Patient Records
Rule 64B16-27.800, Florida Administrative Code

– Change of Ownership
Rule 64B16-28.2021, Florida Administrative Code

– Centralized Prescription Filling, Delivering and Returning
Rule 64B16-28.450, Florida Administrative Code

– Transmission of Starter Dose Prescriptions for Patients in Class I Institutional or Modified II B Facilities
Rule 64B16-28.503, Florida Administrative Code

– Class II Institutional Pharmacies
Rule 64B16-28.605, Florida Administrative Code

– Remote Medication Order Processing for Class II Institutional Pharmacies
Rule 64B16-28.606, Florida Administrative Code

– Automated Pharmacy System – Long-Term Care, hospice, and Prison
Rule 64B16-28.607, Florida Administrative Code

– Modified Class II Institutional Pharmacies
Rule 64B16-28.702, Florida Administrative Code

– Record Maintenance for Animal Shelter Permits
Rule 64B16-29.0041, Florida Administrative Code

Make Sure Your Facility is Prepared.

While these rule changes are not final, it is important to recognize if they will be affecting your facility. You should also be making arrangements in your facility to ensure that there is enough computer disk space or physical space to retain these records. Keep in mind that these records retention rules are in addition to any others imposed by other Florida or federal statutes or rules relating to controlled substances or other pharmacy practices.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, 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?

How do you feel about the requirement of pharmacy records to be retained for four years? Please leave any thoughtful comments below.

About the Author: Lance O. Leider 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.

“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 © 1996-2014 The Health Law Firm. All rights reserved.

Compounding Pharmacies Urged to Sign Up for U.S. Food and Drug Administration Oversight

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

It is estimated there are 3,000 compounding pharmacies in the United States, 14 of which have signed up to be regulated by the U.S. Food and Drug Administration (FDA) under the Drug Quality and Security Act. On January 8, 2014, the commissioner of the FDA sent thousands of letters to hospitals and other medical providers that may buy medicines from the compounding pharmacies. The letters urged providers to encourage compounding pharmacies to register as producers of sterile drugs in an effort to protect the public. The letters also mentioned last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). To read a previous blog on the meningitis outbreak, click here.

In November 2013, the Drug Quality and Security Act was passed. Under the law, the FDA does not have absolute authority over compounders, but it creates significant safeguards. To read a previous blog on the Drug Quality and Security Act, click here.

Registering with the FDA is Voluntary.

The goal of the Drug Quality and Security Act is to enact greater controls, tracking, and oversight of the compounding pharmacy industry. Previously, the FDA only regulated manufacturers of medications, leaving compounding pharmacies to be regulated by state boards of pharmacy. However, this two-part regulation left large compounding operations like the NECC in somewhat of a gray area. Large compounding labs mass producing products and shipping across state lines have recently come under fire from state boards of pharmacy.

Overview of the Drug Quality and Security Act.

Under the final legislation, compounders that mix sterile drugs without a prescription and ship across state lines can choose to register as outsourcing facilities. The pharmacies that register are regulated by the FDA rather than by state boards of pharmacy. The hope was that compounding pharmacies will register with the FDA because physicians will prefer using facilities that are federally regulated, and therefore considered safer.

The law also creates a national system for tracking prescription drugs from the manufacturer to retail pharmacies, first this is done through serial numbers on bottles and later through electronic codes. Drug makers will be required to add serial numbers to all drug packages within four years, and within 10 years drug makers must implement electronic codes that can be used to track medicine from the factory to the pharmacy. To read a summary of the Drug Quality and Security Act, click here.

What Registered Compounding Pharmacies Must Agree To.

Compounding pharmacies registering with the FDA must agree to routine inspections, and to report adverse events associated with their products. Registered compounding pharmacies must also pay a fee for the privilege. The FDA is listing on its website the companies that have already registered. Click here to see the list.

Ultimately, the result of voluntary federal oversight will mean more rigorous compliance standards for both in and out-of-state compounding pharmacies. However, the purported benefits (more business and a better reputation) may far outweigh the burden.

If your pharmacy is considering FDA registration it would be best to consult with an experienced health attorney to guide you through the process.

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.

Comments?

What do you think about the number of compounding pharmacies that have signed up to be regulated by the FDA? As a provider, would you consider using compounding pharmacies that have not signed up? Please leave any thoughtful comments below.

Sources:

Palmer, Eric. “Compounders Start to Sign Up for FDA Oversight.” FiercePharma. (January 10, 2014). From: http://www.fiercepharma.com/story/compounders-start-sign-fda-oversight/2014-01-10

Associated Press. “States Urged to Register Compounding Pharmacies.” ABC News. (January 10, 2014). From: http://abcnews.go.com/US/wireStory/states-urged-register-compounding-pharmacies-21489538

Burton, Thomas. “FDA Urges Compounding Pharmacies to Register.” Wall Street Journa. (January 10, 2014). From: http://online.wsj.com/news/articles/SB10001424052702303754404579312680341438784

About the Author: Lance O. Leider 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.

“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.

Drug Quality and Security Act Boosts FDA Regulations Over Compounding Pharmacies

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

On November 18, 2013, the United States Senate voted to increase federal oversight of compounding pharmacies that produce large volumes of mixed drugs. This bill comes in the wake of last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). Click here to read a previous blog on the meningitis outbreak.

This bill does not give the U.S. Food and Drug Administration (FDA) absolute authority over compounders, but creates significant safeguards.

This particular piece of legislation passed the House of Representatives in September of 2013, passed in the Senate in November 2013, and President Obama signed it into law on November 28, 2013. To read a summary of the Drug Quality and Security Act, click here.

Under Law, Registration with the FDA is Voluntary.

The goal of the Drug Quality and Security Act is to enact greater controls, tracking, and oversight of the compounding pharmacy industry. Presently, the U.S. Food and Drug Administration (FDA) only regulates manufacturers of medications, leaving compounding pharmacies to be regulated by state boards of pharmacy.

However, this two-part regulation left large compounding operations like the NECC in somewhat of a gray area. Large compounding labs like NECC that mass produce products to ship across state lines have come under fire from state boards of pharmacy.

At a recent meeting of the Florida Board of Pharmacy’s Compounding Committee, the panel members expressed concerns over the lack of inspections and oversight of pharmacies shipping drugs into Florida. In general, the Committee supported the efforts to strengthen regulations, whether by the FDA or state boards.

Overview of the Law.

Under the final legislation, compounders that mix sterile drugs without a prescription and ship across state lines can choose to register as outsourcing facilities. The pharmacies that register would then be regulated by the FDA rather than by state boards of pharmacy. The hope is that compounding pharmacists will want to register with the FDA because physicians will prefer using compounding pharmacies that are federally regulated, and therefore considered safer.

The law also creates a national system for tracking prescription drugs from the manufacturer to retail pharmacies, first this is done through serial numbers on bottles and later through electronic codes. Drug makers will be required to add serial numbers to all drug packages within four years, and within 10 years drug makers must implement electronic codes that can be used to track medicine from the factory to the pharmacy.

Issues with Previous Inspections.

As mentioned above, the issue of large-scale compounding and nonresident pharmacies was recently discussed by the Florida Board of Pharmacy.

Florida has more than 700 nonresident pharmacy permits outstanding. According to the Board of Pharmacy, approximately half of those are shipping compounded sterile products into Florida.

Prior to the events at NECC, state boards of pharmacy were under the mistaken assumption that their sister boards were appropriately regulating and inspecting these pharmacies. However, it turns out that many of the inspections were conducted by inadequately trained staff, or the staff was misled as to exactly what was going on at the pharmacy.

Many of the pharmacies wrongly informed the state inspectors that they were registered with the FDA as a manufacturer and did not have to provide prescriptions during inspections. This led to largely unregulated production of compounded sterile medications and eventually the meningitis outbreak of 2012.

Florida Board of Pharmacy to Have More Oversight.

Frustrated with the general lack of oversight and the potential harm to Floridians, the Board is preparing to take additional steps to ensure that compounders are appropriately regulated.

Among the possible steps to be taken are:

1. Outsourcing nonresident pharmacy inspections to organizations like the National Association of Boards of Pharmacy (NABP);

2. Require personal inspection by a Florida Board-approved inspector prior to issuing or renewing a license (costs of the inspection would be paid by the permittee);

3. Training specialized compounding pharmacy inspectors; and

4. Creating a Verified Pharmacy Program in conjunction with the NABP and other state boards.

Ultimately, the result of the additional regulations will mean more rigorous compliance standards on both in and out-of-state compounding pharmacies.

New Permit Law for Florida Pharmacies that Compound Sterile Products.

The Florida Board of Pharmacy also recently announced a new law which will be required for pharmacies that compound sterile products. Effective September 23, 2013, Rule 64B16-28.100(8), Florida Administrative Code (F.A.C.), requires most pharmacies that engage in the preparation of sterile compounded products in Florida to obtain a Special Sterile Compounding Permit. Pharmacies compounding sterile products under their current pharmacy permit may continue to do so, but must obtain the new Special Sterile Compounding Permit on or before March 21, 2014. To read more, click here.

These new standards will make it easier for authorities to quickly spot where tainted batches of medications were produced. It is important to regularly review the Board of Pharmacy rules and USP guidelines to ensure your facility is compliant.

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.

Comments?

Have you heard of these new possible pharmacy regulations? How will this affect you or your pharmacy? Please leave any thoughtful comments below.

Sources:

Lee, Jaimy. “Bill Boosting FDA Authority Over Compounding Pharmacies Heads to Obama.” Modern Healthcare. (November 18, 2013). From: http://www.modernhealthcare.com/article/20131118/NEWS/311189973/bill-boosting-fda-authority-over-compounding-pharmacies-heads-to?utm_source=frontpage&utm_medium=newsitem309&utm_campaign=carousel-traffic

Perrone, Matthew. “Pharmacy Bill Set for Test Vote in Senate.” Washington Post. (November 11, 2013). From: http://www.washingtonpost.com/politics/pharmacy-bill-set-for-test-vote-in-senate/2013/11/11/a961c958-4b25-11e3-9890-a1e0997fb0c0_story.html

About the Author: Lance O. Leider 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.

“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.

“Operation Main Pain” Targets More Than 60 in Fraudulent Prescription Drug Ring

PS 3 Indest-2009-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Sarasota County Sheriff’s Office announced a fraudulent prescription drug ring bust that spanned throughout Sarasota and Manatee counties in Florida, on September 19, 2013. So far, 61 people, including the alleged ringleader have been arrested. The operation has been dubbed “Operation Main Pain” by the Sarasota County Sheriff’s Office.

Click here to view the press release from the Sarasota County Sheriff’s Office.

Investigation Unveiled Complex Fraudulent Drug Ring.

The investigation began in July 2011, when a fraudulent oxycodone prescription was noticed at a CVS pharmacy in Sarasota County. When more of the same fake prescriptions were presented at the CVS pharmacy, the prescriptions were identified as suspicious and declined, according to the Bradenton Herald.

Investigators uncovered that the fraudulent prescription drug ring involved several recruiters who employed runners to enter into pharmacies multiple times a day with identical prescriptions. The recruiters had runners fill fake prescriptions primarily at two pharmacies, one in Venice, Florida, and one in Sarasota, Florida.

According to the Bradenton Herald, detectives say the ringleader wrote 220 phony prescriptions that were exchanged for nearly 20,000 oxycodone pills.

To read the Bradenton Herald article, click here.

Charges Against Those Involved Include Trafficking.

According to the Herald-Tribune, the arrests have been ongoing for two years, with the latest arrests made as recently as September 2013. The ringleader is charged with conspiracy to traffic in oxycodone. The other 60 people arrested face multiple counts of obtaining oxycodone by fraud and trafficking charges.

Sarasota Sheriff Expresses Disappointment in Two Main Pharmacies Accused of Filling Fake Prescriptions.

The two pharmacies targeted by the drug ring allegedly filled more than 100 of the fraudulent prescriptions in a short amount of time. According to the Herald-Tribune, the Sarasota Sheriff’s Office works to educate pharmacies to notice warning signs. The sheriff stated that the pharmacies should have notified the authorities since there were hundreds of similar prescriptions, being brought in by similar customers, all allegedly written by the same doctor. According to the Herald-Tribune, the pharmacies are currently being investigated.

Click here to read the article from the Herald-Tribune.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, 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?

Given the information in the blog, do you think the two main pharmacies that were filling the fraudulent prescriptions should have notified the authorities? Please leave any thoughtful comments below.

Sources:

Rose, Wendy. “Operation Main Pain Includes 61 Arrests.” Sarasota County Sheriff’s Office. (September 19, 2013). From: http://www.sarasotasheriff.org/press_detail.asp?R=13-182

Johnson, Elizabeth. “More Than 60 Arrested in Drug Fraud Ring.” Herald-Tribune. (September 19, 2013). From: http://www.heraldtribune.com/article/20130919/ARTICLE/130919529?tc=ar

Bradenton Herald. “61 Charged with Prescription Drug Fraud in Manatee, Sarasota.” Bradenton Herald. (September 19, 2013). From: http://www.bradenton.com/2013/09/19/4726950/61-charged-with-prescription-drug.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.

New Permit Law for Florida Pharmacies that Compound Sterile Products

LOL Blog Label 2Lance O. Leider, 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

The Florida Board of Pharmacy announced a new law which will be required for pharmacies that compound sterile products. Effective September 23, 2013, Rule 64B16-28.100(8), Florida Administrative Code (F.A.C.), requires most pharmacies that engage in the preparation of sterile compounded products in Florida to obtain a Special Sterile Compounding Permit. Pharmacies compounding sterile products under their current pharmacy permit may continue to do so, but must obtain the new Special Sterile Compounding Permit on or before March 21, 2014.

Click here to read the notice from the Florida Board of Pharmacy.

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 authorities to quickly spot where tainted batches of medications were produced.

Special Sterile Compounding Permit Exceptions.

All permitees that are currently compounding sterile products are required to submit an application to obtain the Special Sterile Compounding Permit.

However, the exceptions are for stand-alone Special Parenteral/Enteral pharmacies, Special Parenteral/Enteral Extended Scope pharmacies, pharmacies that only perform non-sterile compounding, and non-resident pharmacies.

How to Apply for the Special Sterile Compounding Permit.

To obtain the new Special Sterile Compounding Permit, an applicant must already hold another pharmacy permit and must submit an application for the new permit. Those applying for this permit will be required to submit information from current policies and procedures which will be reviewed before an inspection is requested from the Florida Board of Pharmacy.

The application is available by clicking here.

Once approved, the Florida Board of Pharmacy will issue a new Special Sterile Compounding Permit. This means pharmacies that compound sterile products will have two pharmacy permits.

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 this new permit is a direct result of the recent issues with compounded medications and compounding pharmacies. The aim of the permit is to help authorities, such as the Department of Health (DOH) and U.S. Food and Drug Administration (FDA), track Florida pharmacies compounding sterile products.

New Requirements Released for Physician Medical Records Related to Compounded Medications.

Similarly, 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 became effective on September 9, 2013. The standards are contained in Florida Administrative Code Rules adopted by each board. Click here to read our previous blog on this.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, 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?

Had you heard of this new permit? How will this affect pharmacies compounding sterile products? Please leave any thoughtful comments below.

About the Authors: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the OrlandSeptember 18, 2013o, 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.

Generic Drug Maker Ranbaxy Pleaded Guilty to Claims of Adulterated Drugs-Must Pay $500 Million Fine

4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Generic drug maker Ranbaxy USA Inc., pleaded guilty to drug safety violations and will be responsible for paying $500 million in criminal and civil fines, according to the Department of Justice (DOJ). The fines will resolve claims that the manufacturer sold inferior drugs and made false statements to the U.S. Food and Drug Administration (FDA) about manufacturing practices at two factories in India. This announcement was made by the DOJ on May 13, 2013. This settlement is the largest drug settlement to date involving a generic drug manufacturer and drug safety.

To read the entire press release from the DOJ, click here.

Ranbaxy USA Inc., is a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited. The entities listed in the settlement include: Ranbaxy, Inc., Ranbaxy Pharmaceuticals, Inc., Ranbaxy Laboratories, Inc., Ohm Laboratories, Inc., and Ranbaxy USA, Inc. (collectively “Ranbaxy”).

Criminal Fine and Forfeiture.

Ranbaxy admitted to not conducting proper safety and quality tests of several drugs manufactured at two of its plants in India, according to the DOJ. Under the settlement the company pleaded guilty to three felony counts of violating the federal drug safety law. Ranbaxy agreed to pay $150 million in criminal fines and forfeitures.

False Statements Made to FDA.

According to the DOJ, Ranbaxy also pleaded guilty to four felony counts of knowingly making false statements to the FDA in annual reports. To settle civil claims under the False Claims Act and related state laws, Ranbaxy agreed to pay $350 million. This fine was to resolve false claims that were submitted to government health care programs such as Medicare, Medicaid, TRICARE and the Department of Veterans Affairs. The settlement was entered into by all 50 states, the District of Columbia and the federal government.

Florida Will Receive $3 Million from Settlement.

According to the Florida Attorney General (AG), Florida will receive more than $3 million as a result of the settlement. AG Pam Bondi stated that the Medicaid Fraud Control Unit (MFCU) will not allow Florida taxpayers to pick up the tab for pharmaceutical companies that manufacture, distribute and sell adulterated pharmaceutical drugs.

Click here to read the settlement agreement between the State of Florida and Ranbaxy.

Example of Florida’s Civil Forfeiture Act.

This is an example of Medicaid fraud through the use of adulterated and “counterfeit” drugs, as well as the use of Florida’s Civil Forfeiture Act in a Medicaid case. To learn more on civil forfeiture and defending against seizures of property, click here for a previous blog.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, 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 this settlement agreement? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA.” Department of Justice. (May 13, 2013). From: http://www.justice.gov/opa/pr/2013/May/13-civ-542.html

Meale, Jenn. “Attorney General Bondi Enters $350 Million National Settlement with Ranbaxy Resolving Adulterated Drug Claims” Florida Office of the Attorney General. (May 14, 2013). From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/505E50CA109D827885257B6B006BA668

Settlement Agreement between the State of Florida and Ranbaxy Laboratories Limited. Case No. 10-05-01. (May 14, 2013). From: http://www.thehealthlawfirm.com/uploads/Ranbaxy%20Settlement%20agreement.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.

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