This presentation by Sharon Roberts outlines the effects of the Federal Drug Supply Chain and Security Act, or DSCSA or the Drug Quality and Security Act, DQSA and its effects on entities licensed by the State of Florida Department of Business and Professional Regulation and Drug Device and Cosmetics Program. To see more from Sharon Roberts, CDR and attorney visit her site at http://sharonroberts.org/

1. The Federal Drug Quality and Security Act in Florida
by: Sharon Roberts, CDR

2. 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?

3. What is the
projected
timeline?
*
*this graph comes from: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm382022.htm

4. 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

5. 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.

6. 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):

7. 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.

8. 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.

9. 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!

10. 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