TrackTrace Rx

Month: March 2016

DSCSA Pharmaceutical Labelling: The Legal Position

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One of the reasons we have a Drug Supply Chain Security Act (DSCSA) is that supply of counterfeit prescription drugs has grown to huge proportions. The FDA Counterfeit Drug Task Force reported ten years ago that “the FDA has seen growing evidence of efforts around the world by increasingly well-organized counterfeiters backed by sophisticated technologies and criminal operations to profit from drug counterfeiting” and there is evidence that the problem has multiplied in the past decade.

Criminals in Egypt, to take only one example, counterfeited the cancer drug Avastin using only starch and salt and a variety of substances none of which appeared in the genuine formulation. Those fakes passed through genuine distributors in Switzerland, Denmark and Britain on their way to the USA.

Methods to counteract the problem include an anti-counterfeit packaging market worth US$100 billion at present and estimated to double in the next four years. The World Health Organization (WHO) estimates that up to 15% of all medicinal products in the world are counterfeit.

Theft through truck hijacking and warehouse break-in is also a serious problem; one single break-in resulted in $75 million worth of genuine prescription drugs being illicitly released onto the market.

It might be as well to re-cap the critical DSCSA implementation dates:

  • Lot-level traceability is already in force and has been since January 2015
  • By November 2017, manufacturers must serialize all pharmaceutical products
  • By November 2023, every stakeholder in the distribution of prescription drugs in America from manufacture to dispensing must have bought into and implemented a system giving electronic traceability of each drug package.

Manufacturers, third-party logistics companies, wholesalers and dispensers might all find life easier if FDA had laid down detailed guidance on the format and content of labels, but they have not done so. What they sound the subject is, “FDA has not established standardized forms for …  product tracing information. However, the Agency has issued a draft guidance, “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information,” that establishes initial standards to help trading partners understand the methods available for exchanging product tracing information.” In effect, they have sent to the industry, “This is what you have to deliver,” and left it to the industry to decide how to implement the requirement.

The DSCSA does, however, mandate a unique identifier at package and homogeneous case level by the end of 2017. The label will be required to show:

  • Either the National Drug Code (NDC) or the Global Trade Identification Number (GTI) for that drug
  • The serial number
  • The lot number
  • The expiration date.

Pharmaceutical manufacturers selling to Europe will also be required to have a serial number or unique code on each pack; the object will be the same as the aim of the DSCSA in that it will have to be possible to trace any drugs coming into question all the way back through the supply chain to the place they started from. Fortunately for US manufacturers, it appears at the present time that the European Union requirement (Directive 2011/62/EU) will be, for practical purposes, the same as the DSCSA regulation.

There is a whole field of cost considerations that manufacturers will need to take into account, but this post deals with what the law demands and not with what it will cost manufacturers to comply. Compliance is not a matter of choice. Any manufacturer who wants to sell either in the USA or in Europe will have to meet DSCSA requirements.

Nor is DSCSA the only source of and reason for labelling requirements. The FDA’s guidance notes on “Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products —  Content and Format” are described as “non-binding recommendations” but it might be unwise to fail to follow any FDA recommendations just because they are described as non-binding. Unless the guidance notes have been challenged, we recommend treating them as though they had force of law. There is a strong case for arguing that FDA’s reason for describing guidance notes as non-binding is not (as they claim) to encourage discussion but so that they cannot be prevented from taking action against any party involved in manufacturing or distributing prescription drugs on the grounds that what that party has done is not covered in guidance notes.

The most important consideration in those particular notes is the one that says, “if a product has FDA-approved patient labeling (e.g., Patient Package Insert, Medication Guide, and Instructions for Use), such labeling must be referenced in the PATIENT COUNSELING INFORMATION section.” The reason FDA gives for this provision is, “reference to patient labeling informs health care providers of the existence of approved patient labeling and should direct them to advise patients to read such labeling.”

That guidance concerns information that should be on the label in order to be available both to practitioners and to the patient for whom the drug has been prescribed. There is also guidance on providing information on the label specifically for health practitioners. Warning of adverse reactions to the drug is particularly important in this connection and is aimed at practitioners rather than patients. FDA guidance notes “Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products” provide general principles for choosing which adverse reaction data should be provided and in what format.

Separate lists are required for adverse reactions identified in clinical trials and those identified from spontaneous reports after a drug has been marketed. The guidance notes are detailed and complex and both manufacturers and healthcare providers should refer to them, but in general terms it should be assumed that the most clinically serious reactions should be identified first.

Free DSCSA Evaluation

Contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.

DSCSA Transmission: Which Technology will be the Standard for the Future?

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When DSCSA was passed into law, certain requirements were laid on all the elements in the distribution chain for prescription drugs but, for the most part, the method of implementation was left to the individual parts of the chain to negotiate and agree amongst themselves. One area of uncertainty is the Saleable Returns verification method, which has to be in place by November 2019. The end of 2019 seemed a long way in the future when the Act was passed but seems so no longer. There is disagreement on what the supply chain should be doing now.

The Healthcare Distribution Management Association (HDMA) represents primary pharmaceutical distributors who take product from pharmaceutical manufacturers and deliver it to healthcare providers. HDMA members can be expected to have a view on what should be done; the emerging problems are arising because they have more than one. The HDMA’s “Big 3” – McKesson, Cardinal and AmerisourceBergen (ABC) – have taken different positions, with McKesson and Cardinal going down one route and Amerisource choosing another.

Information on shipments has to be passed electronically and there are two major ways to do this:

  • EDI ASN
  • EPCIS

EDI ASN

ASN stands for Advanced Shipping Notice and is exactly what it sounds like: a message sent by shipper to consignee advising:

  • What is being shipped, including details of the number of items, the shipment date, number of boxes and weight of the shipment and a description of packaging
  • Method by which the goods are being shipped
  • Information about the carrier.

An ASN is normally sent by EDI (electronic data interchange and not, as is sometimes said, electronic data information) and this method is usually referred to as EDI ASN, or simply ASN.

EPCIS

Electronic Product Code Information Service (EPCIS) is a global GS1 standard for swapping Electronic Product Code (EPC) information. EPCIS allows EPC data to pass seamlessly and securely between companies.

The advantage of EPCIS is that it allows automatic communication and the exchange of authenticated data. Reading the tag as the goods leave the sender’s premises can cause an ASN to be transmitted without human intervention.

Adoption of EPCIS across an industry would enable computers to communicate automatically with one another and pass data back and forth—with the right authentication—automatically. So the process could be automated. Tag reads at dock doors could automatically trigger software to send an ASN in the right format to the retailer’s EPCIS. The question is not: should pharmaceuticals adopt EPCIS? They should. The question is: is this the right time?

During the last HDMA Expo, each of the “Big 3”, Amerisource Bergen, McKesson and Cardinal had their own sessions to talk about DSCSA data transmissions to their partners and what they would like to see in the next upcoming years.

Amerisource says that it is and wants to see EPCIS implemented as soon as possible for transmission of all types of data. McKesson and Cardinal say that it is not and their option is:

  • EDI ASN for lot base
  • EPCIS for serialization.

*This creates two parallel electronic data pathways. 

The Amerisource argument is: why have two electronic data pathways running in parallel when one would be sufficient and it’s fairly clear that EPCIS will eventually handle all transmission? Against this has to be set the fact that a lot of work has already gone into building an EDI ASN network while EPCIS still needs development.

It might be possible, and indeed a number of people have said this, to wish that the HDMA would publish the definitive guidelines on how data is to be transferred but – presumably because of the difference of opinion between the Big 3 – HDMA has restricted itself to publishing EDI and barcode guidance. Manufacturers still need to ask each wholesaler how they want data presented.

At the moment, it seems that all wholesalers allow DSCSA Transaction Information, Transaction History and Transaction Statement (TI, TH and TS) by EDI ASN and it is certainly true that all of the Big 3 currently receive all of these documents through ASNs – paper transactions have all but ceased for the last 15 months.

HDMA has begun piloting nine different transmission methods to find which combine lowest cost with greatest efficiency. The results should be available in third or fourth quarter of this year. That has not prevented each of the Big 3 from saying that, by the beginning of 2018, all manufacturers should be providing aggregation data so that the wholesalers can build up an inventory of valid serial numbers. The object is to have, from November 2019, different ways to verify saleable returns without phone calls or emails.

So will manufacturers all be providing serialization data through EPCIS? Amerisource clearly expects manufacturers to time EPCIS transmission to coincide with compulsory serialization. McKesson and Cardinal, on the other hand, point out that until November 2023 lot-based transaction documentation will comply with DSCSA. Adding serial numbers is permitted but optional, and must not interfere with meeting the DSCSA requirements on lot-based documents.

McKesson says that suppliers have achieved stability in sending lot-based transaction documentation through ASNs and see no reason to disturb that with a switch to EPCIS that would still require a level of debugging. The ASN system we currently have will be DSCSA compliant to November 2023. McKesson does not want to see that go into the melting pot.

A manufacturer wishing to send aggregation data to McKesson and Cardinal will need to do so in a separate data exchange running in parallel with the ASN compliance data. Two different feeds each containing information about the same products.

The decision might be easier if we already knew the structure or method of exchange of information post-2023 – but we don’t. It may be that the data will still pass between trading partners as it does under ASN now but it is also possible that there will be a more centralized architecture, which may or may not be a central repository for information. That’s a decision the FDA is to make some time during the next 5 to 7 years. McKesson’s argument, which is also supported by Cardinal, is that there is no point in now going through the work needed to construct a working EPCIS system if the FDA then dictates that it has to be done differently. ASN works, so why not stay with it until the future is clearer?

If Amerisource insists that all suppliers switch to EPCIS, manufacturers will have no choice. If, though, they make it optional, the wise choice will be to wait and see – and stay with ASN in the meantime.

Free DSCSA Evaluation

Contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.

6 Things You can do to Improve your Supply Chain

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According to McKinsey Corp, “Up to half the cost of many supply chains lurks ignored and unmanaged in outbound logistics and behind the closed doors of distribution centers.” A European study put logistics at 12 percent of the total cost in manufacturing and more than 20 percent in the retail sector, but McKinsey says, “Pharma logistics represent about 2 percent of sales, or 7 to 8 percent of the cost of goods sold,” though it goes on to say that this is less than in other industries and points out that the outbound supply chain is often outsourced.

As McKinsey says, it is probably for these reasons that optimizing outbound logistics has not been a strategic priority for American pharma companies. DSCSA, however, with its emphasis on the absolute security of the pharmaceutical supply chain from first research to the point of dispensing to the final consumer, is likely to change that.

Inefficient or unreliable warehouse operations and distribution always offered a threat that amounted to more than just money. Delivery delays and wrongly routed shipments can cause lasting reputational damage and, where the customer is a large retailer, the cost can be heavy and lasting. What DSCSA adds to that mix is the threat of FDA penalties.

According to McKinsey, 95 percent of logistics costs are bound up in warehouse operations and transportation and the consultancy sees the possibility of significant savings in those areas.

Optimizing the warehouse, though, is not as straightforward as optimizing a production line. You can’t set out a program for improvement until you’ve benchmarked current performance. If this warehouse is owned by the pharmaceuticals company and stores nothing for anyone else, that may not be so difficult, but that is rarely the case. Most warehousing is outsourced and the same warehouse will be handling goods for a variety of clients with a large number of SKUs. Some goods turn over every day and others perhaps once a year. No one has yet defined the perfect warehousing model.

Security is somewhat easier to define, at least in principle: the objective is to lose nothing, ever, and the challenge of best practice is to achieve optimum cost reduction while keeping the product totally secure. We’ll look at the major causes of inventory shortfall, but before examining the ones that no one likes to think about, we’ll focus on two words: human error. People get things wrong, which is why in just a moment were going to put stress on training.

1. Prevent Loss through Damaged Product

The warehouse that never damages product has not yet been built. There are, however, steps you can take to reduce it to an absolute minimum. These can be serious numbers; if a warehouse handles $10 million of stock in a year, cutting wastage by one percent puts $100,000 straight onto the bottom line.

2. Perform Regular Training

Training is always important but for warehouse staff it can have extra advantages. The fact is that people working in warehouses do not always feel valued and knowing that their employer is investing in their future can change that. The fact that well-trained people cause less wastage through damage is a welcome side-effect. Part of training is establishing a correct location for every item in the warehouse and making sure that everyone knows what it is. You’ve got an inventory system; is everyone trained in how to use it?

3. Reduce handling

Every time someone touches a product, there is the risk – however small – of damage. Good layout and the right equipment can reduce human handling to a minimum. Loss through damage tends to fall in parallel.

4. Purchase Correct equipment

Material handling is a specialist field and any company that does not have an expert on the staff is well advised to seek outside help. Selecting the best equipment for the way your operation is set up and the products it handles, and then making sure that it’s correctly installed to suit the physical circumstances, can pay large dividends.

5. Prevent Loss through Incorrect Records

The first question anyone running a warehouse should ask themselves is: how do you know that you lost inventory? The most reliable way is to install a warehouse management system that integrates with your ERP in real time. We’ve already mentioned human error and human error is part of a much larger problem which is that the correct data does not get entered in the first place. If you had to focus on only one area of your logistics chain, this would be it. Errors in data entry can be calamitous. Eventually, the introduction of DSCSA should reduce this problem because information will be passed electronically, but that deadline is still some distance away.

6. Prevent Theft

Most people are honest. Society couldn’t function otherwise. But theft happens and, let’s be frank, when you’re handling drugs, even of the prescription kind, there are people who want what you’ve got. Of course you have CCTV, alarm systems, perhaps uniformed guards – and yet some inventory continues to disappear. That’s because all those precautions you put in place are to prevent people from breaking in – but some theft is by people inside the company. It isn’t nice, no one likes to think about it but it’s there. How do you deal with it? Well, people who work for you know how your system works and they will find any gaps in security but:

  • Have internal video and make sure it’s regularly monitored so that equipment failures are identified and fixed
  • Install the most robust checking system you can to identify questionable transactions
  • Let staff know that internal theft is not tolerated and anyone caught it always prosecuted.

On the other hand, you don’t want to instill an atmosphere of fear and distrust. The most efficient operations are always those where the people involved are motivated and motivation comes from believing that you are a valued and respected member of staff.

Free DSCSA Evaluation

Contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.

Who, When, What and How – DSCSA Reporting By Wholesale Distributors and Logistics Providers

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Who, When, What and How – DSCSA Reporting By Wholesale Distributors and Logistics Providers

The Drug Supply Chain Security Act (DSCSA) sets out to provide a safe and secure process to get drugs all the way from the manufacturer’s laboratory and the manufacturing plant to the final consumer. There are a lot of steps along the way and the DSCSA places requirements and responsibilities on manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers. What concerns us in this post today is the reporting requirements the Act places on wholesale distributors and logistics providers.

Wholesale distributors and third-party logistics providers (3PLs) are required to be licensed by the FDA. They are also required to submit annual reports. It’s easy enough to know who is a licensed wholesale distributor or 3PL because the FDA maintains a list of them all on its website. If a company claims to be licensed and is not on the FDA website the first assumption must be that it is not, in fact, licensed and further enquiry should be made before dealing with such a company.

It is possible for one company to be licensed as both a wholesale distributor and a logistics provider. In such cases, the company must submit to separate reports: one as a wholesale distributor and one as a logistics provider.

The FDA requires that each facility owned by a company should be given its own unique identifier and that these identifying numbers should be included in the reports.

Wholesale distributors: initial report

The first report submitted to the FDA by any wholesale distributor is known as the initial report. Note that a report has to be submitted for each facility; a single report for the whole company is not sufficient unless the company only has one site. This applies also to subsequent reports. The report falls into two sections:

Identifying information for the facility

  • Name of the company (in the same form as it appears on the license)
  • Address of the facility
  • Contact information: the name, email address and telephone number of a person authorized to interact with FDA
  • All trade names under which the company does business

Licensure information for each State 

  • Name of State
  • State license number
  • Date the license expires
  • Significant disciplinary actions by any State or Federal agency occurring in the 12 months preceding the initial report identifying the type of disciplinary action, the date of final disciplinary action, and the state where the disciplinary action occurred

Documents associated with the disciplinary actions should accompany the report.

Third party logistics providers: initial report

The first report submitted to the FDA by any third party logistics provider is known as the initial report. Once again, a report has to be submitted for each facility; a single report for the whole company is not sufficient unless the company has only one site. The report falls into two sections:

Identifying information for the facility

  • Name of the company (in the same form as it appears on the license)
  • Address of the facility
  • Contact information: the name, email address and telephone number of a person authorized to interact with FDA
  • All trade names under which the company does business

Licensure information for each State 

  • Name of State
  • State license number
  • Date the license expires
  • Significant disciplinary actions by any State or Federal agency occurring in the 12 months preceding the initial report identifying the type of disciplinary action, the date of final disciplinary action, and the state where the disciplinary action occurred

Documents associated with the disciplinary actions should accompany the report.

Some States don’t have a separate licensing arrangement for 3PLs and in such cases no license number or expiry date can be provided but the FDA still requires that each State in which a 3PL operates should be included on the report.

Subsequent reports

The requirements for reports submitted after the initial reports are that they should contain the same information as the initial reports and reports are required to be submitted in the timeframe January 1 to March 31 each year.

In addition, reports of significant disciplinary actions should be submitted to the FDA within 30 days of the final action or ruling by a State or Federal licensing authority. A report should also be sent for any facility that goes out of business or voluntarily withdraws from a State or Federal license.

How to report

The FDA maintains a reporting portal through which 3PLs and wholesale distributors can submit their annual reports. FDA asks for reports to be submitted as XML files in a standard Structured Product Labelling (SPL) format.

TrackTraceRx customers utilize the TrackTraceRx system to automatically submit this report. If you don’t have our system, please contact us and we will walk you through submitting this annual report manually.

Penalties Under the Drug Supply Chain Security Act

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The Drug Supply Chain Security Act (DSCSA) was passed to meet a serious need: the need to protect the American public from the effects of fake or stolen prescription drugs. The penalties that can be imposed for failure to meet the terms of the Act are correspondingly severe, with possible fines up to $500,000, together with terms of imprisonment.

The first thing to remember is that it is only breaches of the Act that will be punished. Two types of instruction are given to entities that form part of the drug supply chain:

  • Mandatory; and
  • Advisory

The “Advisory” category embraces all of the guidance from the FDA since the Act was passed. This guidance does not have the force of law and failure to follow it will not result in prosecution or the imposition of penalties so long as what is in the Act is followed.

For example, in October last year the FDA issued a document, DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy (Revised). On the cover page it says, “This guidance is for immediate implementation.” It goes on with a lot of words about how to respond, should you wish to, but those words “for immediate implementation” suggest that this is something that dispensers have to do, and have to do NOW.

And it isn’t so. Not until you reach the fourth page do you find the words “Contains Non-binding Recommendations” followed by this: “This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.”

So now we know that, not only do dispensers not have to follow the guidance in this document, but the FDA makes no promise (“not binding on FDA”) that it won’t prosecute someone for following the advice should it (the FDA) subsequently decide that the advice wasn’t such a good idea after all.

In short, this guidance is advisory and not mandatory. The document goes on to make this even clearer than it already is: “In general, FDA’s guidance documents do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.” So what MUST be followed is not what it says in the guidance but what it says in the Act.

The guidance contains an interesting date for anyone reading this at the time it is posted because one of the things it says is that until 1st March 2016 the Agency (that’s the FDA) will not prosecute any dispenser for accepting ownership of prescription drugs without receiving the product tracing information. If you are reading this, then that date is already past and now the FDA will prosecute (or certainly may prosecute) any dispenser who accepts ownership of prescription drugs without being provided with the product tracing information. That prosecution will not be under this guidance document but under section 582(d)(1)(A)(i) of the Act. If a dispenser complies with that section but fails to maintain the product tracing information received, that will be a breach of section 582(d)(1)(A)(iii) of the Act and is also likely to result in prosecution.

We’ve gone into detail on this one small section of the act in order to point up the difference between the advisory (guidance documents from the FDA) and the mandatory (what’s in the Act). This example could be repeated many times because there are a number of guidance documents and it’s a complex and detailed act; the question now is: what penalties may be applied?

Here are some things to bear in mind:

  • If you don’t comply with the DCSA’s traceability provisions or licensure requirements you are committing a prohibited act
  • If no product identifier is affixed to the product as the DSCSA requires, this will be regarded as misbranding and is a prohibited act.

Prohibited acts also include the following:

  • The resale of a compounded drug that is labelled “not for resale.”
  • The intentional falsification of a prescription.
  • The failure to report drugs or adverse events by a registered entity.
  • Advertising or promoting a compounded drug in a way that is false or misleading in any particular.

Depending on which prohibited act has been committed, the penalties include:

  • Imprisonment for not more than one year and/or a fine of not more than $1,000.
  • For subsequent or intentional violations, imprisonment for not more than three years and/or a fine of not more than $10,000.
  • Equitable remedies may also be applied and these can include: restitution; disgorgement of profits; and confiscation of product.

There is an additional provision under the Federal Criminal Code allowing a general fine of up to $250,000 for individuals and $500,000 for entities.

All of that is in addition to the penalties for failing to meet the requirements for T3 documentation, failure to meet any of the deadlines in the Act (though, as we have seen, the FDA has extended some of these deadlines), or failing to meet the serialization requirements of the Act as the relevant date milestones are past.

In the case of those infringements, the penalties include fines, imprisonment and suspension or revocation of licenses.

So, if the question is: What penalties are available under DSCSA? then the answer is: Penalties severe enough to make it worth the while of every involved entity to ensure they do not infringe on the Act in any way. If i had to bet the farm here is what is at risk:

Loss of License
Fines
Patient Risks
Negative Reputation

Free DSCSA Evaluation

Contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.

First Responders and the DSCSA

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The Drug Supply Chain Security Act  (DSCSA) enforcement discretion ended today March 1, 2016 for pharmacies and dispensers. However, yesterday Feb 29, the FDA posted a new guidance called “Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act–Compliance Policy; Guidance for Industry“.  In this guidance the FDA does state that transactions between dispensers and first responders may present challenges. The listed challenges are “exchange of product tracing information,” “conducting businesses with authorized trading partners,” and “having a verification system in place.”  Due to these challenges, The FDA has decided to take no action against certain trading partners and first responders until further notice.

So what does this mean? It means in that if you perform any transactions with any first responders such as an ambulance company and don’t have a process in place for managing T3s with them, the FDA will not take any action against you. However, for everything else, dispensers must comply with all other requirements of the DSCSA.

Free DSCSA Evaluation

Contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.