TrackTrace Rx

Month: February 2016

One Day left for the March 1st Deadline – Recap Your Definition Terms

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As we prepare for the new DSCSA March 1st deadline, it is probably a good idea to become familiar with what most DSCSA terms mean. Terms such as “Trading Partners” or “Suspect Product”.  Here are few popular definition terms:

Quarantine. The term `quarantine’ means the storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures.

Affiliate.–The term `affiliate’ means a business entity that has a relationship with a second business entity if, directly  or indirectly–
            “(A) one business entity controls, or has the power to
        control, the other business entity; or
            “(B) a third party controls, or has the power to control,
        both of the business entities.
        “(2) Authorized.–The term `authorized’ means–
            “(A) in the case of a manufacturer or repackager, having a
        valid registration in accordance with section 510;
            “(B) in the case of a wholesale distributor, having a
        valid license under State law or section 583, in accordance
        with section 582(a)(6), and complying with the licensure
        reporting requirements under section 503(e), as amended by the
        Drug Supply Chain Security Act;
            “(C) in the case of a third-party logistics provider,
        having a valid license under State law or section 584(a)(1), in
        accordance with section 582(a)(7), and complying with the
        licensure reporting requirements under section 584(b); and
            “(D) in the case of a dispenser, having a valid license

        under State law.

 Dispenser. The term `dispenser’–
            “(A) means a retail pharmacy, hospital pharmacy, a group
        of chain pharmacies under common ownership and control that do
        not act as a wholesale distributor, or any other person
        authorized by law to dispense or administer prescription drugs,
        and the affiliated warehouses or distribution centers of such
        entities under common ownership and control that do not act as

        a wholesale distributor.

Disposition. The term `disposition’, with respect to a
    product within the possession or control of an entity, means the
    removal of such product from the pharmaceutical distribution supply
    chain, which may include disposal or return of the product for
    disposal or other appropriate handling and other actions, such as
    retaining a sample of the product for further additional physical
    examination or laboratory analysis of the product by a manufacturer
    or regulatory or law enforcement agency.
Distribute or distribution.–The term `distribute’ or
    `distribution’ means the sale, purchase, trade, delivery, handling,
    storage, or receipt of a product, and does not include the
    dispensing of a product pursuant to a prescription.
Exclusive distributor. The term `exclusive distributor’
    means the wholesale distributor that directly purchased the product
    from the manufacturer and is the sole distributor of that
    manufacturer’s product to a subsequent repackager, wholesale
    distributor, or dispenser.
Homogeneous case. The term `homogeneous case’ means a
    sealed case containing only product that has a single National Drug
    Code number belonging to a single lot.
Illegitimate product. The term `illegitimate product’
    means a product for which credible evidence shows that the
    product–
            “(A) is counterfeit, diverted, or stolen;
            “(B) is intentionally adulterated such that the product
        would result in serious adverse health consequences or death to
        humans;
            “(C) is the subject of a fraudulent transaction; or
            “(D) appears otherwise unfit for distribution such that
        the product would be reasonably likely to result in serious
        adverse health consequences or death to humans.
Licensed. The term `licensed’ means–
            “(A) in the case of a wholesale distributor, having a
        valid license.
Manufacturer. The term `manufacturer’ means, with
    respect to a product–
            “(A) a person that holds an application approved under
        section 505 or a license issued under section 351 of the Public
        Health Service Act for such product, or if such product is not
        the subject of an approved application or license, the person
        who manufactured the product.
Package.
            “(A) In general.–The term `package’ means the smallest
        individual saleable unit of product for distribution by a
        manufacturer or repackager that is intended by the manufacturer
        for ultimate sale to the dispenser of such product.
            “(B) Individual saleable unit.–For purposes of this
        paragraph, an `individual saleable unit’ is the smallest
        container of product introduced into commerce by the
        manufacturer or repackager that is intended by the manufacturer
        or repackager for individual sale to a dispenser.
Product identifier. The term `product identifier’ means
    a standardized graphic that includes, in both human-readable form
    and on a machine-readable data carrier that conforms to the
    standards developed by a widely recognized international standards
    development organization, the standardized numerical identifier,
    lot number, and expiration date of the product.
Return. The term `return’ means providing product to
    the authorized immediate trading partner from which such product
    was purchased or received, or to a returns processor or reverse

    logistics provider for handling of such product.

Specific patient need. The term `specific patient need’
    refers to the transfer of a product from one pharmacy to another to
    fill a prescription for an identified patient. Such term does not
    include the transfer of a product from one pharmacy to another for
    the purpose of increasing or replenishing stock in anticipation of
    a potential need.
Suspect product. The term `suspect product’ means a
    product for which there is reason to believe that such product–
            “(A) is potentially counterfeit, diverted, or stolen;
            “(B) is potentially intentionally adulterated such that
        the product would result in serious adverse health consequences
        or death to humans;
            “(C) is potentially the subject of a fraudulent
        transaction; or
            “(D) appears otherwise unfit for distribution such that
        the product would result in serious adverse health consequences
        or death to humans.
Third-party logistics provider. The term `third-party
    logistics provider’ means an entity that provides or coordinates
    warehousing, or other logistics services of a product in interstate
    commerce on behalf of a manufacturer, wholesale distributor, or
    dispenser of a product, but does not take ownership of the product,
    nor have responsibility to direct the sale or disposition of the
    product.
Trading partner. The term `trading partner’ means–
            “(A) a manufacturer, repackager, wholesale distributor, or
        dispenser from whom a manufacturer, repackager, wholesale
        distributor, or dispenser accepts direct ownership of a product
        or to whom a manufacturer, repackager, wholesale distributor,
        or dispenser transfers direct ownership of a product; or
            “(B) a third-party logistics provider from whom a
        manufacturer, repackager, wholesale distributor, or dispenser
        accepts direct possession of a product or to whom a
        manufacturer, repackager, wholesale distributor, or dispenser
        transfers direct possession of a product.
Transaction history.–The term `transaction history’
    means a statement in paper or electronic form, including the
    transaction information for each prior transaction going back to
    the manufacturer of the product.
Transaction information.–The term `transaction
    information’ means–
            “(A) the proprietary or established name or names of the
        product;
            “(B) the strength and dosage form of the product;
            “(C) the National Drug Code number of the product;
            “(D) the container size;
            “(E) the number of containers;
            “(F) the lot number of the product;
            “(G) the date of the transaction;
            “(H) the date of the shipment, if more than 24 hours after
        the date of the transaction;
            “(I) the business name and address of the person from whom
        ownership is being transferred; and
            “(J) the business name and address of the person to whom
        ownership is being transferred.
Transaction statement.–The `transaction statement’ is a
    statement, in paper or electronic form, that the entity
    transferring ownership in a transaction–
            “(A) is authorized as required under the Drug Supply Chain
        Security Act;
            “(B) received the product from a person that is authorized
        as required under the Drug Supply Chain Security Act;
            “(C) received transaction information and a transaction
        statement from the prior owner of the product, as required
        under section 582;
            “(D) did not knowingly ship a suspect or illegitimate
        product;
            “(E) had systems and processes in place to comply with
        verification requirements under section 582;
            “(F) did not knowingly provide false transaction
        information; and
            “(G) did not knowingly alter the transaction history.
Wholesale distributor. The term `wholesale distributor’
    means a person (other than a manufacturer, a manufacturer’s co-
    licensed partner, a third-party logistics provider, or repackager)
    engaged in wholesale distribution.

FDA – DSCSA Is Finally Here! Schedules DSCSA Workshop to Pilot Studies

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The FDA is finally getting serious about the DSCSA and to prove this they have released a DSCSA workshop to pilot their studies. This work shop will take place on April 5-6 to discuss and get feedback from leaders within the pharmaceutical industry. The FDA will collect inputs on related issues to track and trace and challenges that get in the way of implementing the requirements established under the DSCSA.

TrackTraceRx will be there during this workshop representing our network of clients providing factors of challenges on the DSCSA.

You can find out more about the two day workshop here!

What DSCSA Means For Pharmacists

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Since 1st November 2015, everyone dispensing prescription medicine in the US must comply with the Drug Supply Chain Security Act (DSCSA). That means every pharmacy, and every clinic, hospital, care facility and physician involved in the dispensing of any prescription medicine. DSCSA casts its net wide.

Where there is compliance there is enforcement. Where there is enforcement there is inspection and verification. So what must the pharmacist – every pharmacist – be prepared for? And what can happen if they are not?

Let’s begin by addressing what DSCSA is for. If the FDA believed that:

  • No drug was ever incorrectly manufactured
  • No drug drug manufacturer ever subcontracted drug manufacture to an unapproved source
  • All warehouses and all containers and trucks were entirely secure against theft
  • No logistics contractor ever succumbed to the temptation to buy counterfeit drugs
  • Every every pharmacist insisted on buying only drugs that could be proved to be correctly manufactured and that, as with logistics contractors, no pharmacist ever fell prey to the temptation to buy counterfeit drugs

… then there would be no need for a Drug Supply Chain Security Act.

But DSCSA exists and we must therefore assume that the FDA does not believe the statements listed above to be true.

The purpose of DSCSA is to provide a “track and trace” system that allows every drug in the USA to be traced from the moment of manufacture to the moment it is dispensed. When the act is fully in force, every package of every drug will bear a unique identifying code or number allowing it to be traced all the way through the supply chain. If there is ever a need to retrace every step of the route the drug took from manufacture to pharmacist’s customer, DSCSA will meet that need.

Nature Of Tracking

Tracking earlier in the chain will be part substantive and part transactional – that is, making sure the product was correctly manufactured and is what it is supposed to be as well as following the path it takes. As far as pharmacists are concerned, tracking is entirely a transactional matter. It must be possible to check every single transaction the pharmacist is involved in, from acquisition of a drug package to dispensing of the drug.

Inspections 

The purpose of an inspection is simple: to verify that rules laid down by the FDA under DSCSA have been complied with. Because checking of pharmacists is transactional (see above), what all pharmacists have to ensure is that every single transaction they enter into is documented and recorded.

The inspection may be carried out by the FDA, or – when a product has been recalled, or when there is suspicion that products in the supply chain may be suspect or illegitimate – by federal or state officials.

Necessary Documentation

The most important document that must be available at all times is the T3 – the DSCSA Transaction History, Information and Statement. Whether an inspection is random or motivated by suspicion, inspectors may choose any product or products and ask to see the relevant T3. Pharmacist should ensure that every T3 they have:

  1. is the correct T3 for the product to which they attach it; and
  2. contains the required data elements and meets the DSCSA requirements as to format.

For point (a) above, it is not enough for the pharmacist to know that the T3 they have is the right one for the product to which they have attached it; they must be able to prove that – to demonstrate beyond doubt that product and T3 match up.

An inspection is also likely to require the pharmacist to demonstrate the process by which the pharmacist meets the requirements of the Act in relation to archival and retrieval of T3 documents. The wise pharmacist will anticipate spot checks to show that this process does what it is supposed to do: that it allows documents to be retrieved quickly and efficiently.

Verification

There will be times when an inspection takes place because the inspectors believe that a particular product in the pharmacist’s possession may be suspect. Various factors may amount to suspicion: belief that the product may have been counterfeited, or that it may have been stolen, adulterated or otherwise made unfit for final use. The pharmacist may not be party to this suspicion and the inspector will have no duty to inform the pharmacist that suspicion exists.

It follows that the nature of the information and documentation the pharmacist will be asked to produce may not be straightforward. Although the Act does not specify everything that might be asked for, the wise pharmacist to whom we have already referred will wish to be sure of the ability to produce supporting evidence for every step and every date set out in the T3. It follows that T3s should be carefully checked at the time the goods they relate to are received – more on this below.

Penalties

A pharmacist unable to produce the required T3 documentation, or who produces inaccurate or inadequate documentation, may face a number of penalties. DSCSA envisions the fining of pharmacists in the circumstances; the product may also be quarantined.

There is also to be considered the fact that not all drugs received by a pharmacist are delivered to the end consumer. Pharmacists also on occasion lend, swap or resell drugs and when they do so they must ensure that they complete a T3 to mark the transaction; if this T3 contains inaccurate data, action may be taken against the pharmacist by the FDA or by state officials.

Finally, we have said that DSCSA exists to provide a “track and trace” system, but that is not its only objective. It also places on all elements in the supply chain – and that does include pharmacists – a responsibility to identify suspect drug products and report related issues. As well as implementing a recording, archival and recovery system allowing T3s to be produced at any point, pharmacists must also develop the habit of closely examining all T3s coming into their possession to ensure:

  1. that they accurately report the transaction that terminated with the receipt by the pharmacist of the drug batch named in the T3; and
  2. that nothing in the T3 would give an observant, informed and cautious recipient any reason to question the authenticity of the chain of transactions mentioned in the T3 or of the legitimacy of the drug itself.

This may be summarized as: “Don’t just receive and file the T3; read it carefully, too.”

Free DSCSA Evaluation

With the deadline fast approaching, 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.

The Importance of Collaboration Across the Supply Chain

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collaboration

We have less then 30 days before the DSCSA March 1st deadline. The first step in becoming compliant is creating a collaboration plan with your trading partners.

Collaboration by all parties in the supply chain has been the subject of discussion for some time. As far back as 2008, a survey of the Consumer Package Goods (CPG) industry showed that collaboration was one of the main issues concerning companies, with 80% of those surveyed saying that they were involved in at least one collaboration initiative and some involved in as many as ten.

What companies were looking for then, and are still looking for today, is:

  • Cost savings resulting in improved bottom lines at a time when margins are under serious pressure
  • Greater cooperation resulting from the change from an antagonistic to a cooperative stance.

With the advent of the Drug Supply Chain Security Act (DSCSA), however, companies engaged in the manufacture, transport and sale of affected drugs have more than that to concern themselves with. DSCSA demands infallible traceability of prescription medicines and imposes on all parties the need to make sure that no failure in traceability exists. For manufacturers, wholesalers, logistics suppliers, retailers and dispensers, there is an unavoidable, unbreakable requirement to be able to track every consignment and every item on every step of its journey from laboratory bench to consumer.

No company involved in the chain can expect to meet its obligations unaided.

Timelines

There are some timelines that tell companies involved in the drug supply chain what they have to do:

  • The first target date passed a year ago; from January 1 2015, trading partners have been permitted to purchase products only from authorized trading partners and must exchange transactional data on a lot batch level. Trading partners must have a system or process in place to investigate and quarantine products that are “suspect” or illegitimate, and notify the FDA and immediate trading partners.
  • From November 1 2017, manufacturers must add a “product identifier” to each individual package and homogeneous case of product.
  • From November 2023, the DSCSA will turn into an electronic, serialized records retention system.

Collaboration Is Not As Straightforward As It Seems

Even if all the changes that need to be made in the supply chain affected only one company, getting them right would still be difficult. There has to be a commitment to collaboration at all levels from senior management through middle managers to teams on the front line. Chinese whispers can mean that the message that started out in the boardroom is delivered to the shop floor in a completely different set of words with a different meaning. But now we are looking for collaboration not between departments but between companies, who in the past may have seen their interests as to some extent in conflict with each other.

To take the most simple example, a manufacturer may be intent on getting a new product out into the marketplace as quickly as possible, while the distributor has one eye on skinny margins and is much more interested in getting cost out of product handling and storage (an article in Supply Chain Digital suggested that the supply chain contributes between 9% and 17% of cost in the end-to-end value chain).

The DSCSA exists and, difficult or not, collaboration has to happen. With the first of our timeline points already passed and the requirement in operation, trading partners must now be looking at the November 2017 deadline for product identifiers. It is manufacturers who have to add the identifier, but if others in the chain are to find the end result satisfactory, they need to be engaging with manufacturers in a conversation about how the identifiers are to be presented.

The Elements of Supply Chain Track and Trace Technologies

Some of this is taken out of participants’ hands because the act says the product identifier is to be a standardized graphic (two-dimensional dot matrix) that carries the product’s standardized numerical identifier (SNI), lot number, and expiration date in both human-readable and machine-readable format. For those without a clear understanding of how supply chain track and trace technologies work, here is a brief introduction.

Let’s begin with the distinction between Master Data and Instance Data – or, Non-transactional Data and Transactional Data. Master Data is persistent and non-transactional; it contains a unique identifier; and it defines a business entity. “Business entity” does not just mean “company”; customer, location, employee and product are all examples of business entities that qualify for Master Data because they don’t change. The product remains the product; the location the location; the employee remains the employee.

What DSCSA requires is that Master Data applies not just within the company but right down the supply chain from beginning to end. In the past, a product may have gone through six different identifiers on its way from laboratory bench to consumer; now, there can only be one. What we are suggesting is that 2017 is not very far away and logistics companies, distributors and everyone else involved should be engaging with the manufacturers now to make sure that the Master Data identifiers allocated by the manufacturers are acceptable at all stages in the process and that the definition of the data elements is understood and accepted by all parties.

An example of what we have described as Transactional or Instance Data would be a lot number allocated to a specific batch. That batch begins its journey from the factory and ends being broken down for delivery to individual consumers. Once again, the act requires the data to remain exactly the same from one end of the chain to the other and – once again – this is the time for everyone involved in the chain to be discussing what it will contain and what it will look like. If those discussions don’t take place, the transactional data will still be created (indeed, it’s created now at the factory) and everyone will have to accept it as it is.

Free DSCSA Evaluation

With the deadline fast approaching, 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.