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Aug 28, 2014

What You Don't Know About the Drug Supply Chain Security Act (DSCSA) Implementation Plan


What You Don't Know About the Drug Supply Chain Security Act (DSCSA) Implementation Plan
How do you know the prescription drugs 
you take are safe and not counterfeit?
by Peter Knauer, Senior QCC Consultant, MasterControl Inc. and 
Moj Eram, Regulatory Consultant

This article discusses the implementation aspects of the new Drug Supply Chain Security Act (DSCSA), which was signed into law (Title II of Public Law 113-54) by President Obama on November, 27, 2013. The Act intends to build a comprehensive, standard electronic and interoperable system to identify and trace prescription drugs in the US.1

Since the formation of the first FDA Counterfeit Drug Task Force in 20032, the agency has been engaged in efforts to improve and enhance the security of the drug supply chain at multi-level efforts that involves all stakeholders. The aim is to protect U.S.  patients from ineffective, counterfeit, low quality and unsafe drugs that enter to the market. Counterfeit, mislabeled, adulterated, or otherwise compromised prescription drugs pose serious public health safety concerns that are being addressed through the new Act. These drugs may be contaminated or contain faulty ingredients, inaccurate dosage, inactive ingredients or toxic ingredients. As a result of these drugs entering the market, patients risk their health by unknowingly using these faulty products.

As an example, the adulteration of Zyprexa by substituting aspirin instead of the correct active ingredient for patients with schizophrenia and acute bipolar disorder created significant health risk to those patients. In another case, counterfeiters replaced vials of the anemia treatment drug Procrit with vials that were 20 times less active than they the labeled indicated2&3. These examples show that there are justifiable cases for implementation of the Act.



This article is related to the Whitepaper: FDA Inspections of Clinical Investigators: Are You Ready? To get the full details, please download your free copy

The FDA is taking further steps by providing a more comprehensive and nationwide standardized drug supply chain via the published draft guidance on industry Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification as amended by Congress in the DSCSA4. The goal is to establish a nationwide standard to replace the existing regulations established individually by states. The loopholes in many existing state regulations allow counterfeit, adulterated and unsafe drugs to reach the public without the broad oversight by the Agency. This guidance provides helpful suggestions for increased vigilance for the identification and reduction of risks associated with unknowingly acquiring illegal and illegitimate drugs and products. The guidance is provided to assist trading partners, which are identified as manufacturers, re-packagers, wholesale distributors, or dispensers, to work in coordination to identify the suspect products and notify the Agency regarding adulterated products.

The Agency has proposed a ten-year plan that outlines the requirements for implementation with milestone dates for key provisions. We will discuss some of these provisions below.
Key provisions of the 10-year implementation plan1:

Product identification:     Manufacturers and re-packagers will need to add a bar code or unique (electronically readable) identifier on primary packaging. This will probably be required initially for high risk products, but eventually be required for all products.

Product tracing:               Manufacturers, wholesaler drug distributors, re-packagers, and many dispensers (primarily pharmacies) will be required to provide traceability data on who handles the product essentially every time it is handled.

Product verification:        In conjunction with the previous two items, manufacturers, wholesaler drug distributors, re-packagers, and many dispensers (primarily pharmacies) will be required to scan/read data entered. This implies a bar code scanner or manual logging system.

Detection and response: Manufacturers, wholesaler drug distributors, re-packagers, and many dispensers (primarily pharmacies) are required to quarantine and promptly investigate a drug that has been identified as suspect. This implies a Quality Event Management / CAPA system and provisions for physical segregation of suspect product.

Notification:                     Manufacturers, wholesaler drug distributors, re-packagers, and many dispensers (primarily pharmacies) are required to implement a notification procedure and system that notifies FDA if a suspected adulterated drug is found.

Wholesaler licensing:      Wholesalers are required to be licensed with the Agency. This information will be made available to the public.

Third-party licensing:      Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, are required to obtain a state or federal license.

At this point, no specific timeline has been provided within the ten implementation provisions for these individual requirements. A follow-up to this article will be written once more information is known.

As part of the implementation plan, FDA is required to develop standards, issue a guidance document, conduct public meetings for input, conduct assessment on the plan, and implement pilot programs. There are 15 key activities with planned time frames for FDA’s implementation plan, as described below5. Note that these timelines are for the implementation process and are not for the key provisions described above.

Activity Description
FDA
Timeframe

Publish guidance on identification of suspect product and termination of notification of illegitimate product for finished human prescription drugs

Beginning 2014 – Mid 2014
Establish a system for third-party logistic provider reposting to FDA
Beginning 2014 – Late 2014
Develop regulation establishing standards for licensing wholesale drug distributors
Beginning 2014 – Late 2015
Develop regulation establishing standards for licensing of third-party logistic providers
Beginning 2014 – Late 2015
Publish guidance on processes for waivers, exceptions, exemptions
Beginning 2014 – Late 2015
Conduct at least five public meetings
Beginning 2015 – Mid 2021
Publish final guidance on the standards for interoperable data exchange to enhance secure tracing of product at package level
Beginning 2018 – late 2022

Draft Guidance Summary
According to the draft guidance, beginning January 1, 2015, a trading partner who determines a product is an illegitimate product must notify the FDA and its immediate trading partner of such product under section 582 of FD&C Act (21 U.S.C. 360eee), as added by the DSCSA. The definition and identification of “suspect product” and “illegitimate product” are two key features of the draft guidance. Note that this is a draft guidance, which does not yet mandate these actions, but we highly recommend to our clients that these actions be implemented by the proposed dates.

According to the draft guidance, a “suspect product” is defined as a product for which there is a reason to believe:
  • is potentially counterfeit, diverted or stolen;
  • is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
  • is potentially the subject of a fraudulent transaction; and 
  • appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.
“Illegitimate product” is defined as a product for which credible evidence shows that it is:
  • counterfeit, diverted or stolen 
  • intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; 
  • is the subject of a fraudulent transaction; and
  • appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.
The guideline further provides examples of specific scenarios and situations involving trading partners that could significantly increase the risk of a suspect product entering the pharmaceutical distribution chain. Trading partners should be diligent in transactions that involve:

Trading partners and product sourcing:
  • purchasing from a source new to the trading partner; 
  • receiving an unsolicited sales offer from an unknown source;
  • purchasing on the Internet from an unknown source; and
  • purchasing from a source a trading partner knows or has a reason to believe has transacted business involving suspect products.

Supply, demand, history and value of product:
  • product that is generally in high demand in the US market;
  • product that is in higher demand because of its potential or perceived relationship to a public health or other emergency (e.g., antiviral drugs);  
  • product that has a high sales volume or price in the United States; 
  • product that has been previously or is currently being counterfeited or diverted (e.g., HIV, antipsychotic, or cancer drugs); 
  • product that has been previously or is currently the subject of a drug shortage;
  • product that has been or is the subject of an illegitimate product notification under the DSCSA or other alert or announcement related to drug quality; and 
  • product that has been or is the subject of an FDA counterfeit or cargo theft alert.

Appearance of the product:
  • appearance of a package or a container used for transport (e.g., case or tote) that seems suspicious (e.g., it has a label that contains misspellings or appears different from the standard label for that product in color, font, images, or otherwise); 
  • package that uses foreign terms, such as a different drug identification number rather than the National Drug Code (NDC);
  • package that is missing information, such as the lot number or other lot identification or the expiration date;
  • package that is missing anti-counterfeiting technologies normally featured on the FDA-approved products that are easily visible to the eye, such as holograms, color shifting inks, or watermarks; and 
  • finished dosage form that seems suspicious (e.g., it has a different shape or color from the FDA-approved product, a different or unusual imprint, an unusual odor, or there are signs of poor quality like chips or cracks in tablet coatings or smeared or unclear ink imprints).

The draft guidance further provides recommendations for trading partners to diligently look for suspect product by close examination of packages and the transport containers, close examination of the label on the package, or any other clues that may render a product as suspect. For assessment of suspect product, trading partners are encouraged to work with law enforcement and the Agency to make an accurate determination.

The last section of the draft guidance is dedicated to the notification of illegitimate product and process for FDA notice. Notification requirements also take effect January, 1, 2015. Trading partners will be required to notify FDA by submitting Form FDA 3911 and any immediate trading partners that may have received any illegitimate product no later than 24 hours after making determination that a product is illegitimate. Note again that this is a draft guidance, which does not yet mandate these actions, but we highly recommend to our clients that these actions be implemented by the proposed dates.

As January 1st, 2015 is fast approaching, trading partners should implement training programs for their employees so that they understand the definition and process of looking for and identifying suspect and illegitimate product. Please contact MasterControl Quality and Compliance Consulting for further details on implementing this new Act.

References:

2.     Counterfeit Drug Task Force Report October 2003 - THE COUNTERFEIT DRUG TASK FORCE: http://www.fda.gov/Drugs/DrugSafety/ucm174399.htm

 

3.     Appleby, J (2003) Fake Drugs Show up in US Pharmacies: http://usatoday30.usatoday.com/money/industries/health/drugs/2003-05-14-fakedrug-cover_x.htm

 

4.     Draft Guidance for Industry DSCSA Implementation: Identification of Suspect Product and Notification: http://www.rxtrace.com/2014/06/the-fdas-draft-guidance-on-suspect-product-and-farewell-columbus.html/#more-5555




Moj Eram is a freelance regulatory consultant in Salt Lake City, UT. She has over 10 years of research experience in academia, and more than nine years of experience in business and technology development in medical devices, therapeutics and diagnostics. Her focus has been on strategy development for startups and small enterprises. She holds a PhD form the University of Utah School Medicine in physiology and a bachelor’s degree in biology from Oregon State University. She is currently completing her graduate certification degree in regulatory affairs at Utah Valley University. Contact her at moj.eram@gmail.com.


Peter Knauer is a partner consultant with MasterControl's Quality and Compliance Advisory Services. He has more than 20 years of international experience in the biomedical industry, primarily focusing on supply chain management, risk management, CAPA, audits and compliance issues related to biopharmaceutical and medical device, chemistry, manufacturing and controls (CMC) operations. He was most recently head of CMC operations for British Technology Group in the United Kingdom and he has held leadership positions for Protherics UK Limited and MacroMed. Peter started his career at Genentech, where he held numerous positions in engineering and manufacturing management. He is currently chairman of the board for Intermountain Biomedical Association (IBA) and a member of the Parenteral Drug Association (PDA).





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