The Federal Drug Quality and Security Act in Florida

by: Sharon Roberts, CDR

The Federal Drug Supply Chain and Security Act (DSCSA) also known as the Drug Quality and Security Act (DQSA) changes the Federal Food, Drug, and Cosmetic Act to enable the Food and Drug Administration to act with more authority with respect to regulating and overseeing  the manufacturing of compounded drugs.

The goal of these changes is to manage the pharmaceutical supply chain and protect patients from compromised medicines.

What is it?

What is the projected timeline?

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*this graph comes from: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm382022.htm

If you are an entity licensed by the State of Florida Department of Business and Professional Regulation (DPBR), Drug, Device and Cosmetics Program, this new Federal Regulation effects you in the following ways (as of 1/1/2015):

What does it all mean?

Transactional Changes and Drug Exemptions

If you are an entity licensed by the State of Florida Department of Business and Professional Regulation (DPBR), Drug, Device and Cosmetics Program, this new Federal Regulation effects you in the following ways (as of 1/1/2015):

What does it all mean?

Transactional Changes

• The former Florida Pedigree Form DBPR-2129 and Form 2135 no longer apply to any transaction.

• Instead you must participate in Transaction History (TH), Transaction Information (TI) and a Transaction Statement (TS). Authentication is also pre-empted.

What does it all mean?

Drug Exemptions

• the new Federal Law exempted a few drug items from the TI,TS and TH requirements that had not been exceptions prior in Florida.

• Transactions involving active pharmaceutical ingredients: (API), IV solutions, dialysis solutions and medical convenience kits require neither pedigree nor Transaction information.

If you are an entity licensed by the State of Florida Department of Business and Professional Regulation (DPBR), Drug, Device and Cosmetics Program, this new Federal Regulation effects you in the following ways (as of 1/1/2015):

What stays the same?

If you are an entity licensed by the State of Florida Department of Business and Professional Regulation (DPBR), Drug, Device and Cosmetics Program, then ALL other regulations that have previously applied to you still apply. So keep complying with these requirements until further notice is given.

What stays the same?

If you are an entity licensed by the State of Florida Department of Business and Professional Regulation (DPBR), Drug, Device and Cosmetics Program, then ALL other regulations that have previously applied to you still apply. These regulations include ( but are not limited to) : licensing, certified designated representatives, resident and non-resident permits, record-keeping as provided in F.S. 499.0121(6), inventory, destruction, and more.

Now What?

If you are uncertain as to how these changes impact you, keep following the rules of compliance that you have been until you are able to seek legal counsel. Most likely those rules still apply!

Get More Information

•http://www.fda.gov/

•http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/

•http://tse.nacds.org/presentations/2014/sunday/Supply_Chain_Security_Act.pdf

•http://sharonroberts.org