Drug Enforcement Administration (DEA) Agents May Surprise You at Florida Board of Pharmacy Meeting

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M. Board Certified by The Florida Bar in Health Law

At several recent Florida Board meetings, after hearings at which disciplinary cases were considered by the Board, Drug Enforcement Administration (DEA) agents approached the health professional. Even in instances where the pharmacist was represented by an attorney and the attorney was there, the DEA agents confronted the professional involved.

What Were the DEA Agents Trying to Do?

In the cases where The Health Law Firm’s attorneys were there representing clients, the professional received some type of discipline on his or her license. Some of these were Settlement Agreements. The DEA Agent approached the professional and urged the professional to sign a voluntary relinquishment of DEA registration.

It seems that this is happening to professionals where there is some type of serious or long-term discipline is being taken against their licenses, such as long-term probation, suspension or revocation. Also, if the charges against the health professional involved, drugs, over-prescribing, abuse of narcotics, operation of a “pill mill,” selling or illegally dispensing or prescribing narcotics, drug diversion or abuse, being impaired from use of drugs, and other similar misconduct. These are often grounds for the revocation, suspension or revocation of the DEA number.

This action by DEA agents has occurred at Board of Medicine meetings and hearings, Board of Osteopathic Medicine meetings and hearings, Board of Dentistry meetings and hearing and Board of Pharmacy meetings and hearings. If you are a professional who has a DEA registration and number, you are, apparently, fair game.

Don’t Be Surprised; Be Prepared and Don’t Make a Rash Decision.

It is unusual to see federal agents of this type “cruising” state professional board meetings like we have seen lately. But, it seems to make sense, from the DEA’s point of view. If you can take several minutes and convince, surprise or intimidate a health professional into relinquishing his or her DEA registration voluntarily, then you may save the government hundreds of hours of time and thousands of dollars in expenses in having to investigate and have a separate administrative hearing (which the health professional may win), if he or she voluntarily relinquishes the DEA registration.

Immediately consult with an experienced health law attorney who has dealt with the DEA before.

Remember Your Rights; Yes, You Have Rights!

Yes, you do have rights, Constitutional rights. Use them! That is what they are there for.

You have the right to consult with counsel before making a decision. Don’t believe it if a DEA agents tells you that you don’t.

You have the right not to sign any forms or make any statements. Don’t sign anything. Don’t make any statements except for getting the agent’s card and telling them you will have your attorney contact them.

You have the right to take time to consider the matter and consult with others. You do not have to make a decision right away.

The Consequences of Voluntary Relinquishment are Serious and Long-Lasting.

Your voluntary relinquishment are serious and long lasting. It will be treated the same as a revocation of your DEA number. We have consulted with physicians and pharmacists who have never been able to get it back after they relinquished it.

You will probably be terminated from any health insurance panels you are on if this happens.

You will probably have action taken against your clinical privileges if you have clinical privileges at any hospital, nursing home or ambulatory surgical center (ASC).

You may be terminated from the Medicare or Medicaid Program.

There are many other consequences that may result.

Therefore, you and your attorney should be aware that this may happen and you and your attorney should be prepared if it does happen.

For more tips on how to prepare, click here to read my prior blog.

Don’t Wait Too Late; Consult with an Experienced Health Law Attorney Early.

Do not wait until action has been taken against you to consult with an experienced attorney in these matters. Few cases are won on appeal. It is much easier to win your case when there is proper time to prepare and you have requested a formal hearing so that you may actually dispute the facts being alleged against you.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing pharmacists, pharmacies and pharmacy technicians in investigations and at Board of Pharmacy hearings. Call now or visit our website www.TheHealthLawFirm.com.

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.

Keywords: Administrative hearing attorney, representation for administrative hearings, administrative complaint defense attorney, Board of Pharmacy representation, Board of Pharmacy attorney, Board of Pharmacy defense attorney, representation for Board of Pharmacy investigations, representation for Board of Pharmacy complaints, DEA hearing defense attoreny, DEA investigation attorney, DEA hearing representation, DEA investigation representation, pharmacist attorney, health care professional defense attorney, representation for health care professionals, professional licensure defense attorney, professional licensure representation, licensure defense attorney, representation for licensure issues, representation for pharmacists, representation for pharmacies, pharmacy attorney, review of The Health Law Firm, The Health Law Firm attorney reviews

“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 © 2018 The Health Law Firm. All rights reserved.

 

 

 

 

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Pharmacies May be Liable for Filling Valid Prescriptions

Lance Leider headshotBy Lance O. Leider, J.D.

Florida pharmacies have had their potential liability significantly expanded by the Fifth District Court of Appeal. In its recent decision, Oleckna v. Daytona Discount Pharmacy, the appellate court held that a pharmacy owes a duty to its patients that go beyond following the prescribing physician’s directions and properly dispensing the medication.

The court defined the pharmacy’s duty to use due care in filling a prescription to mean more than what it called “robotic compliance” with the instructions of the prescribing physician.

From the court’s decision and some others from around the state it would seem that Florida pharmacists are now under an obligation to question the quantity, frequency, dosage, combination, and possibly even the purpose of a valid prescription. Florida pharmacies are no longer simply a conduit for validly prescribed prescription medications. They are now an integral part of the health care system where trained professionals are expected to act as a check and balance on physicians and other prescribers.

This decision is in keeping with recent Florida Board of Pharmacy cases dealing with narcotic pain medications. The Board has interpreted Section 465.003(6), Florida Statutes, and Rule 64B16-27.820, Florida Administrative Code, to place a duty on a pharmacist to use his or her skill and experience to evaluate the propriety of every prescription presented on a global level.

While courts and the Board are more than willing to expand the scope of a pharmacist’s duty to his or her patients, unfortunately, neither have provided any prospective guidance on how to fulfill the duty.

Suggestions for Compliance.

Below are some suggestions for ensuring your pharmacy is fulfilling its obligation to its patients. This list is by no means exhaustive and is only intended to offer some basic guidance.

1. Know the physician and verify the credentials of an unfamiliar one;
2. Check the Prescription Drug Monitoring Program (PDMP);
3. Do not fill prescriptions that are more than 30 days old without verifying them with the prescribing physician;
4. Question higher than normal dosages and more frequent administration instructions;
5. Do not provide early refills without verifiable documentation and contact the physician when the patient is seeking an early refill on a medication with a high potential for abuse (the physician is usually in the best position to recognize drug seeking behaviors);
6. Flag concerning prescriptions for mandatory counseling prior to dispensing to give you an opportunity to discuss the risks with the patient;
7. Check the patient’s profile for interactions and discuss them with the patient and, if necessary, the prescribing physician;
8. Periodically check with the prescribing physician on long term medications;
9. Document everything done to verify the propriety of a prescription in the patient’s record; and
10. Most importantly, don’t be afraid to refuse a fill.

In addition to these steps, you should also be conducting regular staff meetings and routine reviews of your processes to ensure that they remain functional and able to be followed.

Comments?

Do you think a pharmacy or pharmacist should be held liable for filling valid prescriptions? How do you verify you or your employees are in compliance? 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 and visit our website at www.TheHealthLawFirm.com.

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 © 1996-2015 The Health Law Firm. All rights reserved.

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.

Florida Toughens Up Drug Compounding Law for Out-of-State Pharmacies

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A new, stricter law on Florida’s compounding pharmacy industry took effect October 1, 2014.
The new law increases the restrictions for out-of-state compounding pharmacies and outsourcing facilities that ship medications into Florida. The law also gives the Florida Board of Pharmacy and Florida Department of Health (DOH) more power to oversee and penalize these companies. Click here to read the new law.

The law was enacted to increase the standards for compounding pharmacies that create medications that are supposed to be tailored to the needs of individual patients. In an effort to prevent another nationwide outbreak of fungal meningitis, similar efforts to tighten control on compounding pharmacies have been implemented by other states across the country. Click here to read a prior blog on the fungal meningitis outbreak.

The Lowdown on the New Law.

The bill requires an out-of-state compounding pharmacy or an outsourcing facility to obtain a nonresident sterile compounding permit before shipping products into Florida. Any currently-registered nonresident pharmacies must be permitted by February 28, 2015. However, all compounded sterile products shipped, mailed, delivered, or dispensed into the Sunshine State must meet Florida’s standards for sterile compounding.

The law establishes application and inspection requirements for the nonresident sterile compounding permit, as well as increased responsibilities for the Florida DOH and the Board of Pharmacy.

Under the law, the Florida DOH and Board of Pharmacy are given enhanced oversight for these out-of-state compounding pharmacies, including the authority to inspect a pharmacy or sterile compounding permittee; the cost of which is picked up by the pharmacy or permittee. The Board is authorized to discipline a nonresident pharmacy for conduct which causes or could cause serious injury, without waiting 180 days for the resident state to act. The Board is also authorized to discipline nonresident pharmacies and sterile compounding permittees for specified acts of noncompliance.

New Standards Triggered by Tainted Compounded Medications.

These new standards are being implemented two years after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Florida is no stranger to allegations of tainted compounded products. In May 2012, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. To read more: click here for the first blog and here for the second blog.

It’s likely these new permits are a direct result of the recent issues with compounded medications and compounding pharmacies. The goal of these permits is to help authorities, such as the DOH and the Board of Pharmacy, track pharmacies compounding sterile products.

Comments?

What do you think of the law to increase restrictions on out-of-state compounding pharmacies that ship medications into Florida? 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 and visit our website at www.TheHealthLawFirm.com.

Sources:

Shedden, Mary. “Tougher Compounding Rules Finally Law.” Health News Florida. (September 30, 2014). From: http://bit.ly/1xBQtS0

Florida House Bill 7077

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

Out-of-State Compounding Pharmacies May Need a Permit To Do Business in Florida

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

Beginning on October 1, 2014, out-of-state compounding pharmacies may be required to hold a compounded sterile product permit. That’s because the Regulated Industries Committee of the Florida Senate voted on March 13, 2014, to approve a bill increasing the restrictions on out-of-state compounding pharmacies that ship medications into Florida. These increased regulations would apply to around 300 compounding pharmacies shipping medicine to Florida.

The bill was introduced to increase standards for compounding pharmacies that create medications that are tailored to the needs of individual patients. Currently the bill is out for reference review. Considering that this is a hot issue in Florida and nationally, we expect the bill to pass.

Click here to read the entire bill.

Requirements Under the New Bill.

The bill requires out-of-state compounding pharmacies to hold a compounded sterile product permit to ship medications into Florida. Applications for the permit would be provided by the Board of Pharmacy. The bill also requires pharmacies to meet or exceed Florida’s sterile compounding standards. Under the bill, the Florida Department of Health (DOH) is responsible for inspecting out-of-state compounding pharmacies for compliance. The DOH would hold the authority to punish or revoke an out-of-state compounding pharmacy’s license for noncompliance. The pharmacy would be responsible for reimbursing the cost of the inspection.

If the bill passes, compounding pharmacies already shipping compounded sterile products into Florida may continue to do so, as long as the pharmacy receives a permit before January 31, 2015.

Permit Law for Florida Pharmacies that Compound Sterile Products.

Similarly, the Florida Board of Pharmacy promulgated a rule requiring a permit for pharmacies that compound sterile products in Florida. 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.

Click here to read more on this permit.

New Standards Most Likely Triggered by Tainted Compounded Medications.

These new standards are being implemented after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Florida is no stranger to allegations of tainted compounded products. In May 2012, 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.

It’s likely these new permits are a direct result of the recent issues with compounded medications and compounding pharmacies. The goal of these permits is to help authorities, such as the DOH and U.S. Food and Drug Administration (FDA), track pharmacies compounding sterile products.

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 the bill to increase restrictions on out-of-state compounding pharmacies that ship medications into Florida? Please leave any thoughtful comments below.

Sources:

The News Service of Florida. “Pharmacy Bill, FL Budge Taking Shape.” WUSF News. (March 14, 2014). From: http://wusfnews.wusf.usf.edu/post/pharmacy-bill-fl-budget-taking-shape

Palombo, Jessica. “After Federal Compounding Pharmacy Crackdown, Fla. Panel Passes Extra Restrictions.” WFSU News. (February 12, 2014). From: http://news.wfsu.org/post/after-federal-compounding-pharmacy-crackdown-fla-panel-passes-extra-restrictions

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.

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.