Drug Quality and Security Act Boosts FDA Regulations Over Compounding Pharmacies
By 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.
Have you heard of these new possible pharmacy regulations? How will this affect you or your pharmacy? Please leave any thoughtful comments below.
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.
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