Penalties Under the Drug Supply Chain Security Act
The Drug Supply Chain Security Act (DSCSA) was passed to meet a serious need: the need to protect the American...
On November 27, 2013, President Obama signed into law The Drug Quality and Security Act (DQSA). Specifically in that bill, Title II of the DQSA, is the Drug Supply Chain Security Act (DSCSA).
On November 27, 2013, President Obama signed into law The Drug Quality and Security Act (DQSA). Specifically in that bill, Title II of the DQSA, is the Drug Supply Chain Security Act (DSCSA). The DSCSA, outlines the steps necessary to build an electronic interoperable system that can track and trace types of prescription drugs as they are sold and distributed in the United States. The companies that sell prescription drugs are commonly known as a Trading Partner, which are entities or organizations such as a Manufacturer, Repackager, Dispensers and Wholesale Distributors.
Before we begin let’s define what these entities are:
(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;
This falls in line of a NDA holder – (New Drug Application)
A ANDA Holder – (Abbreviated New Drug Application)
A BLA Holder – (Biologic License Application)
A company that repacks and relabels a product or a package for sale or for distribution. This also includes in-house repackaging departments within hospital networks.
A company that dispenses drugs directly to human patients:
A retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or and 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.
Is a organization or company that engages in wholesale distribution of prescription drugs.
Third-Party Logistic Provider (3PL):
Is an entity that coordinates logistics services of a product on behalf of other organizations but does not take ownership and disposition of the product.
“At first glance, when someone reads Title II of the DSCSA and its requirements, one would think that this is almost the same requirements as an epedigree document, but now an epedigree on steroids.”
Is the manufacturer, repackager, wholesale distributor and dispenser from who accepts direct ownership of a prescription drug. 3PLs do not take ownership of the product.
So what does this mean? Well, before this bill was signed, a few states had to comply with product traceability known as a pedigree (e-pedigree or electronic pedigree) requirements. Epedigree is an electronic document which provides a history trail of particular prescription drug. This trail shows transactions for every change of ownership in a supply chain.
Manufacturer -> Distributor -> WholesalerA -> WholesalerB -> Pharmacy – (Transfer of ownership in a supply chain)
Only a few states like Florida and California required ePedigrees. After a few years of state level ePedigree changes, the government decided to do away with epedigrees and create a new form of ePedigree 2.0. The main difference is now this new form of traceability is nationwide instead of state level. At first glance, when someone reads Title II of the DSCSA and its requirements, one would think that this is almost the same requirements as an epedigree document, but now an epedigree on steroids.
Back to my original question, “So what does this mean?”. Well, If you sell, distribute, repackage or manufacturer prescription drugs in the United States, you will need to follow certain guidelines depicted in the section of the DQSA Title II called the DSCSA section 202 related to tracing.
How do you determine if you have to comply with the DSCSA? First question to ask:
Are you a manufacturer, wholesale distributor, repackager or a dispenser?
is your product a prescription drug?
A PRESCRIPTION DRUG is a drug for human use that is subject to FD&C section 503(b)(1). If the law makes it mandatory to mark your product Rx Only, then your product is a prescription drug and falls within the DSCSA.
What are the exemptions?
Blood or blood components intended for transfusion
Radioactive drugs or radioactive biological products that are already regulated by the Nuclear
Regulatory Commission or by a State
Appropriately marked homeopathic drugs
Intravenous products that are intended for the replenishment of fluids and electrolytes or calories
Intravenous products used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions
Products intended for irrigation, or sterile water, whether intended for such purposes or for injection.
Very Important, if you have ANY doubts that your product will be subject to the DSCSA law, please check with the FDA.
Are you performing a transaction between trading partners? The DSCSA defines:
A transaction to be the transfer of prescription between persons in which a change
of ownership occurs.
Here are the exemptions:
i.Intracompany distribution of any product between members of an affiliate or within a manufacturer;
ii.The distribution of a product among hospitals or other health care entities that are under common control;
iii.The distribution of a product for emergency medical reasons, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;
iv.The dispensing of a product to fill a prescription;
v.The distribution of product samples by a manufacturer or a licensed wholesale distributor;
vi.The distribution of blood or blood components intended for transfusion;
vii.The distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use;
viii.The lawful sale, purchase or trade of a drug or an offer to sell, purchase or trade a drug by a 501(c)(3) charitable organization to a nonprofit affiliate of the organization;
ix.The distribution of a product that is acquired as part of the sale or merger of a pharmacy or pharmacies or a wholesale distributor or wholesale distributors, as long as any records required to be maintained for the product are transferred to the new owner;
x.The dispensing of an approved product for use in animals;
xi.Products transferred to or from any facility that is licensed by the Nuclear Regulatory Commission (NRC) or by a State under an agreement with the NRC;
xii.The distribution of a combination product that is regulated by the FDA as a device primary mode of action (PMOA),37 including “medical convenience kits” as described below
xiii.The distribution of “medical convenience kits”, a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user, if:
I.the kit is assembled in an establishment that is registered by the FDA as a device manufacturer;
II.the kit does not contain any controlled substance; and
III.the kit manufacturer purchased the product contained in the kit directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased it directly ￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼￼from the pharmaceutical manufacturer, and the primary container label of the product contained in the kit is not altered;
IV. and the product contained in the kit is:
xiv.The distribution of an intravenous product that, by its formulation, is intended for the replenishment of fluids and electrolytes or calories;
xv.The distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;
xvi.The distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;
xvii.The distribution of a medical gas; or
xviii.The distribution or sale of any biologic product that meets the definition of a device.
What do i call this data? Is it a document like the ePedigree document? Not at all…
The goal was always to have an exchange of tracing data. Data needs to securely be passed on from one trading partner to the next. Some refer it to Interoperable exchange of “transaction information”, “transaction history” and “transaction statements.”
eg. the three “Ts” *Tees (TI/TH/TS)
The Three T’s:
The exchange of data needs to be a paper or electronic format. The exchange of data must contain the Three T’s. Personally i don’t like to refer to the data as the Three T’s, I like to call it, “Transactional Data”.
For the first 10 years this data must be:
At a Lot level.
The transactional data must be stored and retrievable within 48 hours for a period of 6 years.
Let’s look at what each Transactional Data means:
The proprietary or established name or names of the product;
• The strength and dosage form of the product;
• The National Drug Code (NDC) number of the product;
• The container size;
• The number of containers;
• The lot number of the product;
• The date of the transaction;
• The date of the shipment, if more than 24 hours after the date of the transaction;
• The business name and address of the person from whom ownership is being transferred; and
• The business name and address of the person to whom ownership is being transferred.
The Transaction Information is pretty clear cut. It is informational data of the product, name, unit numbers, strength, dosage, size, ndc, container size and numbers, lot number, transaction date, shipment date, business name from and to.
A statement in paper or electronic form, including the Transaction Information for each prior transaction going back to the manufacturer of the product, …except, when provided by a wholesale distributor who bought the drug directly from the manufacturer, the Transaction History may not include the lot number of the product, the initial transaction date or the initial shipment date from the manufacturer. In that case, the Transaction Statement from the wholesale distributor must indicate that the drug was acquired directly from the manufacturer.
The Transaction History includes the Transaction Information for each transaction going all the way back to the manufacturer.
A statement, in paper or electronic form, that the entity transferring ownership in a transaction:
B.received the product from a person that is “authorized”
C.received “transaction information” and a “transaction statement” from the prior owner of the product;
D.did not knowingly ship a “suspect product” or “illegitimate product”;
E.had systems and processes in place to comply with DSCSA “verification” requirements;
F.did not knowingly provide false “transaction information”;
G.did not knowingly alter the “transaction history”; and
H.In some cases, an indication that the entity, or an affiliate, purchased the product directly from the manufacturer, exclusive distributor or repackager that purchased the product directly from the manufacturer
The Transaction Statement goes down the list of checks to make sure all checks are followed.
Transport methods for the Transactional Data: (How do i send this data to my trading partners?)
Electronic Data Interchanges (EDI) standards- such as Advance Ship Notice (ASN)
All transport methods above are valid as long as the information is captured, maintained, and provided in compliance with section 582.
The FDA requires that the exchange of tracing information must encompass “interoperability” which is the ability to exchange tracing information accurately, efficiently and consistently among trading partners to maintain product tracing information in paper or electronic format.
Timeline for Implementation – Timeframes of the DSCSA:
Jan 1st 2015, Everyone must provide Transactional Data (3 Ts) of their drug product at a lot level. This info can be in paper or electronic method as long as it is “interoperable”.
The FDA has one year after the enactment of the DSCSA to publish a draft guidance document that sets standards for interoperable exchange at lot-level. This will help companies in the supply chain in exchanging electronic information.
I feel that in the first few years companies will start with paper documents in order to be compliant.
November 2017 manufactures will need to encode their products with a unique identifier paving the way for serialization and verification at the package level.
November 2023, products will need to be serialized for track and trace.
Changes for 2023
Serialization will need to be added and included in the Transaction Information. Transaction Histories will no longer be required.
Transaction Information and Transaction Statements must be exchanged in a secure and interoperable electronic format that is currently to be determined by the FDA. This data now must be retrievable in 24 hours.
Current Products in the Supply Chain
For any product that are in the supply chain before January 1, 2015, trading partners are exempt from providing transactional information. A transaction history must begin with the owner of that product. Manufacturers and Authorized Trading Partners:
Managing Trading Partners Licenses
Manufacturers, Wholesalers, Repackagers, Dispensers that work with their authorized trading partners must make sure that they have some sort of system to manage their trading partners licenses and that they are kept valid and are not expired.
Illegitimate, Suspect Products
If a product is a suspect product, the entity responsible must immediately quarantine the product until it is either cleared or dispositioned. This can be determined internally, via trading or partners or from the FDA.
A suspect product is a product that in the supply chain that might potentially be a illegitimate product. A coordinated investigation with your trading partners should take place validating your transaction history and transaction information. If the product is found that it is not illegitimate then you must notify the FDA, if applicable that the product has been cleared. At this time it can be removed from quarantine.
A record of the occurrence must be kept for at least 6 years.
If a product has been determined to be illegitimate then the following must take place:
The product must be quarantined.
The product must be dispositioned.
Assist your trading partners
Keep samples of the illegitimate product in case needed by the FDA or the manufacturer.
Notify the FDA, manufacturer and immediate trading partners within 24 hours of your
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.
After consulting the FDA, the manufacturers and trading partners that the issue is resolved.
A record of the occurrence must be kept for at least 6 years.
Wholesale Distributors, Repackagers:
For Wholesale Distributors, Repackagers, Dispensers. Must not accept ownership of a product unless the upstream trading partner provides them with a transaction history, transaction information and a transaction statement.
Unless, the wholesale distributor and Repackagers directly purchased from the manufacturer and is the exclusive distributor or purchased from a repackager that purchased directly from the manufacturer. If this is the case then they do not need a transaction history, transaction information and a transaction statement from the manufacturer.
However, when selling this product…the wholesale distributor must provide the purchaser with a transaction statement indicating that the product was purchase directly from the manufacturer. That they are a exclusive distributor, or the repackager that purchased directly from the manufacturer.
For Dispensers when selling to another trading partners they must provide a transaction history, transaction information and a transaction statement. However, if they are selling to fulfill a specific patient need or directly to a patient or returning the product to the trading partner who originally supplied them.
A returned nonsaleable product maybe returned to the manufacturer, repackager, wholesale distributor without a transaction information, transaction history and a transaction statement.
A returned saleable product maybe returned to the manufacturer, repackager, wholesale distributor without a transaction information, transaction history and a transaction statement until November 27 2019. On November 27 2019, a transaction history must begin with the current owner. When a request of information is sent, the entity will have 1 business day to respond with the appropriate information and not exceed 48 hours. This request can come from the FDA or any other State or Federal agency in an event of a recall.
Wholesalers, Repackagers and Dispensers that work with their authorized trading partners must make sure that they have some sort of system to manage their trading partners licenses and that they are kept valid and are not expired.
Currently each state has their own licensing program for Wholesale distributors. If a state does not have an established licensing program then the State must hold a license issued by the FDA once the FDA established their licensing program.
Beginning on January 1, 2015, any person who owns or operates an establishment that engages in wholesale distribution of drugs shall:
Report to the FDA on an annual basis as scheduled by the FDA:
The States in which the person is licensed and the State license number for those states; o The name, address, and contact information of each facility from which the person conducts business, including all trade names used. Report to the FDA any significant disciplinary actions, such as the revocation or suspension of a license, taken by a State or Federal Government during the reporting period against the wholesale distributor.
No later than January 1, 2015, the FDA must establish a database of authorized wholesale distributors. This database shall:
Identify each authorized wholesale distributor by name, contact information, and each State where that wholesale distributor is appropriately licensed to engage in wholesale distribution;
Be available to the public on the FDA website; and
Be updated regularly on a schedule determined by the FDA.
Challenges moving forward
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The Drug Supply Chain Security Act (DSCSA) was passed to meet a serious need: the need to protect the American...