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Drug Supply Chain Security Act
Businesses that handle prescription drugs and medications have a significant responsibility to consumers prescribed specific drugs.
Because consumers risk exposure to counterfeit, stolen, or generally harmful drugs, regulations and precautions are vital to keeping consumers protected.
One strategy to ensure the safe purchase and consumption of prescription medication is the Drug Supply Chain Security Act (DSCSA).
The DSCSA outlines crucial criteria for distributing drugs in the United States. This Act is essentially a prescription verification system whereby institutions can follow specific steps to ensure safe drug distribution.
This article will outline specific sections and requirements of the act and highlight the essential role temperature and environmental monitoring plays for those subject to the stringent requirements of the act.
The first question you want is: what is the Drug Supply Chain Security Act?
According to the FDA, the DSCSA is an outline of steps necessary to achieve interoperable and electronic tracing of prescription drug products at a package level.
By following these steps, distributors can identify and trace prescription drugs to mitigate the risk of invalid and harmful substances.
The act was created to thwart bad actors and counterfeiters looking to exploit the massive and highly lucrative pharmaceutical industry.
- The purpose of the DSCA is to protect the U.S. domestic supply chain for prescription drugs and to make sure that bad actors and counterfeit products are kept out.
- On Nov. 27, 2023, pharmaceutical supply chain players including manufacturers, distributors, and pharmacies must provide serialized data in transaction information during a product ownership change.
One vital detail provided in the DSCSA is information on saleable returns of prescription drugs.
You might now ask: what is the DSCSA definition of a return under the DSCSA guidelines?
With the DSCSA, saleable drug returns require distributors to verify returns before reintroducing the returns to the supply chain.
The DSCSA’s compliance policy requires that wholesale distributors verify saleable returned products to vet each product and ensure that it is legitimate.
The DSCSA outlines guidelines vital to the safety of any business operating in the healthcare or pharmaceutical industry.
If your business distributes prescription drugs to patients, you must adhere to the guidelines in the DSCSA. There are other ways to ensure the safety and sustainability of prescription drugs in your organization.
For example, your institution must have measures to prevent medication damage due to shifting environmental conditions. Providers like Sonicu are vital to solving any issues with prescription medication storage and damage due to inaccurate environmental conditions.
Scores of retail pharmacies and pharmaceutical distributors rely on Sonic for affordable and trusted temperature and environmental monitoring that meets regulatory requirements for the FDA, USDA and Board of Pharmacy and the Joint Commission.
DSCSA Guidelines
The DSCA outlines specific guidelines and requirements to ensure safe drug distribution practices in the United States.
Instead of studying every last detail of the DSCSA, you may benefit from reading a Drug Supply Chain Security Act summary.
The ultimate purpose of the DSCSA is to improve security around drug distribution while adding necessary controls to ensure safe distribution and consumption.
According to the DSCSA guidelines, distributors must adhere to the following provisions:
- Follow licensure application DSCSA requirements.
- Have procedures regarding pre-licensure drug inspection along with denial, revocation, and suspension of licenses
- Follow established standards for storing, handling, and distributing prescription drugs, including individual facility requirements and drug maintenance.
- Adhere to personnel requirements and necessary qualifications
- Maintain records and document maintenance requirements
- Have requirements for individual written policies and procedures
Some of the chief benefits pharmacy and drug supply chain professional derive from Sonicu include:
- Asset Protection: Get alerts when a freezer is malfunctioning to protect assets like medicines, vaccines, blood, research, sperm/eggs
- Compliance Automation: Creates simple reports to satisfy local/state/federal regulations
- Operational Efficiency: Spend less time capturing data manually: Both temps/conditions and reporting
By following these guidelines, healthcare and pharmaceutical organizations can confidently and safely distribute prescription drugs to consumers.
The Sonicu monitoring system includes DataSync for robust redundancy and operational intelligence. The communicating meter that transmits data from the probe or sensor to the AWS Cloud includes onboard, back-up data and power.
In the event of a power or network outage, the SoniShield Duo meter will continue to operate with backup power designed to run for a year and collect data that will be synced to the cloud once connectivity is restored.
This is an essential differentiating feature that helps Sonicu better serve pharmacies and drug supply chain leaders.
DSCSA Compliance
Organizations responsible for distributing prescription medications for consumers must stay up-to-date on the different guidelines and requirements for DSCSA compliance.
Though reading a Drug Supply Chain Security Act summary is an excellent starting point, you must deepen your knowledge to ensure the safety of you and everyone to whom you provide medication.
Requirements in the DSCSA are subject to change when necessary for the continued safety of consumers.
Because of this, distributors must educate themselves on the upcoming DSCSA 2023 requirements.
A significant change of the law includes tracing drugs at the lot level to the product level, according to a recent interview with Elizabeth Gallenagh, JD, general counsel and senior vice president of supply chain integrity at the Arlington, Virginia-based Healthcare Distribution Alliance (HDA).
“Serialized data in this context means that the supply chain will have information related to transactions—sales of pharmaceutical products from supply chain partner to supply chain partner. This data will be at a finite level. Right now, we have a serialized product at the manufacturer level, which is uniquely identifiable. We also have data exchange of transaction information that is being passed along, but that information is at the lot level,” Gallenagh said in a recent article. “In 2023, the information will be unit-level data tied to a serial number for each product.”
“For example, now, we are passing transaction information statements and history that is not necessarily tied to a specific serial number. After the deadline, that serialized number will be incorporated into the data.”
According to the FDA DSCSA guidance on 2023 requirements, distributors of prescription medication must follow policies regarding the interoperable exchange, verification, and tracing of drugs.
However, some distributors may struggle to understand shifting DSCSA policies. You will benefit from checking to see if your organization meets the requirements for exemption from the DSCSA.
Generally, the exemptions to DSCSA requirements include:
- Exemptions when distributing a prescription drug for medical purposes, such as a public health emergency
- Exemptions from transaction requirements in scenarios where delaying medication will harm the patient
- Exemptions for drug transactions where the product is under common control
What is common control?
Generally, organizations will follow the DSCSA guidelines and comply with FDA standards for safe drug distribution. By following DSCSA compliance regulations, organizations can ensure the safe distribution of prescription drugs to consumers.
Drug Supply Chain Security Act Guidance
Organizations handling the distribution of prescription drugs must ensure that they follow the FDA DSCSA requirements, including any updates and amendments made to the original Act.
To ensure that your organization is safely distributing drugs to consumers, you must understand and adhere to the Drug Supply Chain Security Act guidance to safely manage prescription medication.
Though you previously learned about the upcoming DSCSA 2023 requirements, there are specific guidelines that you must follow to adhere to the legal requirements of drug distribution.
Among the DSCSA guidance requirements are recent measures for implementing the distribution of prescription medication.
One guidance within the DSCSA outlines electronic materials and standards for tracing pharmaceutical products through the entire supply chain.
Another recently implemented guidance by the DSCSA involves identifying trading partners authorized to track products throughout the supply chain.
All trading partners engaged in the U.S. supply chain must only transact with authorized trading partners.
The responsibility is on each entity—manufactures, wholesalers, third-party logistics providers [such as UPS], and pharmacies — to make sure their trading partners are licensed or registered with the Food and Drug Administration in the case of manufacturers.
While safety and security were the main goals, another goal was uniformity to combat a patchwork of state regulations. The federal government acted in 2013 after it decided that the lack of uniformity of track-and-trace laws between and within states left citizens vulnerable to bad actors and counterfeiters.
Sonicu is trusted by many multi-state enterprise organizations that rely on the cloud-based platform to track drug and other high-value, temperature sensitive items at distribution centers and in transit from a single intuitive dashboard or free mobile app.
The DSCSA is title II of the Drug Quality and Security Act of 2013, where the Act was signed into law to ensure proper measures to identify, monitor, and trace specific drugs during the supply chain to avoid counterfeit products.
Though the security measures in the DSCSA are somewhat different today than in earlier stages of the Act, the DSCSA is constantly adapting to new healthcare and prescription needs and health crises whereby some prescriptions are exempt
Drug Supply Chain Security Act Serialization
Drug serialization is essential to the general Drug Supply Chain Security Act summary.
Among the DSCSA 2023 requirements are additional guidelines and requirements for drug serialization.
Serialization helps ensure authentic prescriptions to avoid distributing counterfeit, dangerous substances. Additionally, FDA serialization guidance helps place a unique product identifier on prescription packages to avoid counterfeit medication.
By doing this, distributors make it challenging for counterfeit products to pass as legitimate medication, reducing the number of dangers associated with taking inauthentic prescriptions.
The Drug Supply Chain Security Act serialization guidelines are crucial to preventing harm to consumers accessing counterfeit prescriptions.
DSCSA serialization implements product identifiers, including serial numbers, national drug codes, lot numbers, and expiration dates.
The DSCSA requires distributors only to sell products encoded with serial numbers and other product identifiers. Serialization is a significant part of preventing counterfeit drugs and ensuring the safe distribution of prescriptions.
Because of this, serialization is one of the primary verification methods for distributors and a crucial part of the prescription packaging process. Serialization requires electronic proof of product origins to ensure that no counterfeit substances have entered the supply chains.
If a product has an invalid or nonexistent serial number, distributors can take action to recall medications before further damage occurs.
Drug Supply Chain Security Act Pharmacy Responsibilities
Healthcare and pharmaceutical businesses are most vulnerable to errors in DSCSA compliance protocol.
The DSCSA 2023 requirements outline specific measures and responsibilities for businesses operating in the pharmaceutical industry.
The Drug Supply Chain Security Act pharmacy responsibilities include requirements for a minimum quantity by a licensed pharmacy to a licensed practitioner.
Furthermore, DSCSA pharmacy requirements ensure that distributors can detect illegitimate products before reaching consumers. Reading a Drug Supply Chain Act summary will indicate pharmacies' hefty responsibility to ensure that consumers are safe and protected from dangerous substances.
The DSCSA is crucial because it provides extensive verification systems under the Drug Supply Chain Security Act for certain prescription drugs.
Among the responsibilities of pharmacies outlined in the DSCSA include:
The responsibility to confirm that the entities a pharmacy does business with are licensed or registered
The responsibility to safely receive, store, and provide product tracing documentation
The responsibility to investigate and appropriately handle any suspect or illegitimate drugs
Pharmacies have a massive responsibility to fight against counterfeit medications that harm consumers.
These responsibilities include the ability to properly store medications and maintain appropriate environmental conditions for all prescription drugs.
While some businesses manually monitor environmental conditions, it is essential to switch to a provider like Sonicu to access automated monitoring solutions and ensure the safe distribution and consumption of prescription medicines.
Drug Supply Chain Security Act Timeline
Following the DSCSA 2023 requirements is challenging without a comprehensive timeline to understand the new changes and updates.
Therefore, anyone operating in an industry that adheres to DSCSA serialization guidelines must follow a DSCSA timeline to ensure that they meet all requirements and can safely distribute prescription drugs.
Initially enacted in 2013, the Drug Supply Chain Security Act included a 10-year timeline for full implementation.
The Drug Supply Chain Security Act timeline concludes in 2023 and involves implementations to achieve a fully interoperable electronic tracing system for prescription drugs.
According to the FDA, DSCSA timeline constraints consist of measures to ensure that manufacturers and their trading partners have full, interoperable electronic tracing capabilities for all products at the package level.
The DSCSA timeline also involves a thorough verification process for saleable returns to ensure that medications are valid and safe for consumers.
By the end of 2023, the DSCSA will fulfill its promises to implement safer practices for distributing prescription drugs.
While the DSCSA timeline is reaching its conclusion, your work doesn't stop here. Even after implementing all of the updated guidelines from the DSCSA, your organization needs tools to monitor your medications and ensure proper environmental conditions constantly.
To safely monitor environmental conditions in your workplace and sustain medications, you should implement Sonicu's software to automate your institution's temperature monitoring, logging, and reporting.
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At Sonicu, that means our team of American-based customer success managers who are never more than a phone call away to help field and fix any service issues.
Our probes and sensors are placed in demanding frozen environments and our software literally sends billions bits of data monthly, meaning there’s always the potential for a hiccup on either the hardware or software.
We are committed to fielding every customer service request promptly and addressing our customer’s concerns promptly and professionally.
“I like to say that every refrigerator or freezer is like a car in that they all behave a bit differently,
and then every now and then you just get a bad boy who doesn’t want to perform as we need it to,”
Martha Rardin, Director, Nutrition and Dietetics, Hendricks Regional Hospital.
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to fix them before we have a serious issue.”
Tim Livesay, Director, Hancock Regional Hospital Pharmacy Director
