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.

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Florida Board of Pharmacy Approves Change to Destruction of Controlled Substances Rule

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

At its meeting held in Orlando, Florida, on February 12, 2014, the Florida Board of Pharmacy approved final changes to Rule 64B16-28.303, Florida Administrative Code. This rule governs the destruction of controlled substances by Class II Institutional Pharmacies.

The focus of the new rule changes is to ensure that either the prescription department manager (PDM) or the consultant pharmacist of record signs off on all destruction of controlled substances. Further, the rule requires that a copy of the destruction documents be mailed to the Drug Enforcement Administration (DEA) within one business day of destruction.

According to the Board’s statement, the purpose of the rule change is to make it “easier to properly dispose of [controlled] substances while ensuring that one of the persons signing for the destruction always is either the prescription department manager or the consultant pharmacist of record, and that a copy of the destruction is timely sent to the DEA.”

Who the Rule Applies To.

Although this rule applies to all permittees, pharmacists in Class II institutional pharmacies need to be aware that the Board’s clarifications were specifically aimed at those facilities. In case you are not sure whether you work in a Class II pharmacy, those facilities are defined as pharmacies which “employ the services of a registered pharmacist or pharmacists who, in practicing institutional pharmacy, [] provide dispensing and consulting services on the premises to patients of that institution, for use on the premises of that institution.” Section 465.019(b), Florida Statutes.

More Details of the Rule.

The new rule also states that destruction shall be conducted by at least two people. One will be the PDM or the consulting pharmacist of record and the other has to be one of the following: the medical director of the facility or his/her physician designee; the director of nursing or his/her licensed nurse designee, or a sworn law enforcement officer.

Finally, the rule retains the ability of the pharmacy to destroy the drugs by way of sending them to a reverse distributor in lieu of on-site destruction.

Check our blog regularly for updates on this and other recently adopted rules and changes.

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?

What do you think of this rule change? Will the change affect your job or business? 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 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.

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.

Central Florida Doctor’s Home and Offices Raided Over Alleged Improper Prescribing Practices

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

In a joint operation, law enforcement officials raided the home and two offices of a Central Florida physician on November 8, 2013, according to the Osceola County Sheriff’s Office. The Osceola County Sheriff’s Office alleges that the doctor is being investigated for improper prescribing practices. According to the press release, this is not the first time the physician has been under investigation.

The raid was a collective effort between the Osceola County Investigative Bureau (OCIB), Florida Department of Health (DOH), Drug Enforcement Administration (DEA), Florida Department of Law Enforcement (FDLE), and the Metropolitan Bureau of Investigation (MBI).

Physician Not Arrested After Raid.

On November 8, 2013, law enforcement agents searched the physician’s home and his offices in Kissimmee, Florida and Orlando, Florida. The Florida DOH also issued an emergency order restricting the doctor’s privilege to prescribe narcotics. The physician was not arrested.

The physician was allegedly the target of two separate Florida DOH complaints in June 2013. Both complaints alleged the physician wrote prescriptions for painkillers to patients who did not have a medical need for the drugs. Click here to read the two previous complaints.

Doctor Previously Blacklisted by CVS.

According to an Orlando Sentinel article, this physician was previously placed on a CVS document referred to as the “blacklist.” This list identifies Central Florida’s top physicians prescribing oxycodone. When the list was released, the pharmacy chain notified the physicians that CVS pharmacists would no longer fill their patients’ prescriptions. This blacklist was an effort by CVS to step up internal efforts to combat the nation’s prescription drug abuse epidemic. So far, CVS has released two blacklists, one was released in November 2011, and the second list was released in August 2013. You can read more about the two lists on our blog. Click here for part one, and click here for part two.

To read the Orlando Sentinel article, click here.

Florida Losing War on Prescription Drug Abuse.

Despite the aggressive “war on prescription drugs” the Sunshine State reportedly ranks eleventh highest nationally in drug overdose deaths.

I have represented a number of physicians who have been accused of “overprescribing.” Some of these were criminal investigations by local law enforcement authorities, such as a county sheriff’s office. Some were investigations by the DEA. Some were investigations by the state licensing agency such as the Florida DOH. To read a previous blog, “Legal Tips for Physicians to Manage Pain Patients,” click here.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, 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?

Do you think Florida’s war on prescription drug abuse is working? Please leave any thoughtful comments below.

Sources:

Lizasuain, Twis. “Dr. Ibem Borges Investigated for Over Prescribing Drugs.” Osceola County Sheriff’s Public and Medica Relations. (November 8, 2013).

Pavuk, Amy. “Agents Raid Home, Offices of Central Florida Physician Suspected of Improper Prescribing Practices.” Orlando Sentinel. (November 8, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-doctor-ibem-borges-raid-20131108,0,735835.story

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.