Contributing Author: Super User Submitted Date: 04 Mar 2024
Members of the drug supply chain, particularly wholesalers and manufacturers, have been diligently working to meet the impending deadline for product identifier compliance. The deadline necessitates that pharmaceutical manufacturers affix product identifiers to every package or homogenous case. Initially set for November 27, 2017, the product identifier deadline was extended by the FDA for one year. This extension granted additional time for manufacturers to implement proper labeling before facing regulatory action. In September of this year, the FDA released a draft guidance titled “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers – Guidance for the Industry.” This guidance was issued to address inquiries, apprehensions, and misconceptions regarding the steps drug supply chain members should take as the November deadline draws near. The draft guidance outlined crucial points, addressing many questions that had been foremost on the minds of pharmaceutical supply chain members. Understanding the content of this guidance is paramount, particularly as the deadline extension draws to a close. To shed light on key aspects of the draft guidance, here are some important questions and answers concerning product identifiers under the DSCSA. Which Types of Pharmaceutical Products Require Product Identifiers under the DSCSA? The DSCSA's product identifier requirements apply to packages and homogenous cases of pharmaceutical products, specifically prescription drugs, in a finished dosage form and intended for patient consumption without further substantial manufacturing. Excluded from these requirements are human blood or blood components for transfusion, imaging medications, medical gas, radioactive medications, homeopathic medications marketed in compliance with FD&C act guidelines, and certain intravenous products. All other prescription medications meeting the specified criteria must adhere to the product identifier guidelines. What Differentiates the Required Product Identifiers for the Human Readable and Machine Readable Portions of Drug Package Labels? According to the draft guidance, machine-readable formats must be presented in a 2-dimensional data matrix barcode for packages. For homogenous cases, the machine-readable format should be a linear barcode or a 2-dimensional data matrix. To ensure healthcare practitioners can easily and accurately utilize product information, the guidance suggests a specific format for human-readable product identifiers, comprising the Product NDC, Serial Number, Lot Number, and Expiration Date. Can Manufacturers and Wholesalers Use GTIN Instead of NDC in the Human Readable Part of the Product Identifier? No, the use of GTIN alone as an identifier is discouraged due to the increased risk of misidentification compared to the more user-friendly 3-digit format of NDC. However, GTIN can be included voluntarily alongside NDC if it is already present on the label. Do Product Identifier Requirements Apply to Prescription Medications Marketed Without FDA Approval? Yes, such medications are subject to product identifier requirements under the DSCSA. Manufacturers must submit their product identifier as part of the product labeling for registration, regardless of FDA approval status. Is It Acceptable to Use a 2D Matrix Barcode Instead of a Required Linear Barcode? No, the draft guidance specifies the types of product packaging and the appropriate type of product identifier to be affixed. For example, a 60-count bottle of tablets would require a 2D data matrix barcode, while a homogenous case of 10 bottles, each containing 100 capsules, would necessitate a linear barcode or 2D data matrix. Can a Manufacturer or Repackager Request a Waiver, Exemption, or Exception from the Product Identifier Requirements? Yes, the FDA holds the authority to grant waivers, exceptions, or exemptions from DSCSA product identifier requirements. Parties interested in seeking such relief should refer to the guidance titled “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act” for detailed information and instructions. How Can Serialization and Traceability Processes Required by the DSCSA be Simplified? Entrusting the serialization and traceability processes to a reliable partner offering comprehensive traceability and serialization software solutions can streamline compliance with DSCSA requirements. Such partners handle the intricacies and stresses of compliance, allowing pharmaceutical supply chain businesses to focus on their operations with confidence.
Members of the drug supply chain, particularly wholesalers and manufacturers, have been diligently working to meet the impending deadline for product identifier compliance. The deadline necessitates that pharmaceutical manufacturers affix product identifiers to every package or homogenous case. Initially set for November 27, 2017, the product identifier deadline was extended by the FDA for one year. This extension granted additional time for manufacturers to implement proper labeling before facing regulatory action.
In September of this year, the FDA released a draft guidance titled “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers – Guidance for the Industry.” This guidance was issued to address inquiries, apprehensions, and misconceptions regarding the steps drug supply chain members should take as the November deadline draws near.
The draft guidance outlined crucial points, addressing many questions that had been foremost on the minds of pharmaceutical supply chain members. Understanding the content of this guidance is paramount, particularly as the deadline extension draws to a close. To shed light on key aspects of the draft guidance, here are some important questions and answers concerning product identifiers under the DSCSA.
Which Types of Pharmaceutical Products Require Product Identifiers under the DSCSA?
The DSCSA's product identifier requirements apply to packages and homogenous cases of pharmaceutical products, specifically prescription drugs, in a finished dosage form and intended for patient consumption without further substantial manufacturing.
Excluded from these requirements are human blood or blood components for transfusion, imaging medications, medical gas, radioactive medications, homeopathic medications marketed in compliance with FD&C act guidelines, and certain intravenous products. All other prescription medications meeting the specified criteria must adhere to the product identifier guidelines.
What Differentiates the Required Product Identifiers for the Human Readable and Machine Readable Portions of Drug Package Labels?
According to the draft guidance, machine-readable formats must be presented in a 2-dimensional data matrix barcode for packages. For homogenous cases, the machine-readable format should be a linear barcode or a 2-dimensional data matrix.
To ensure healthcare practitioners can easily and accurately utilize product information, the guidance suggests a specific format for human-readable product identifiers, comprising the Product NDC, Serial Number, Lot Number, and Expiration Date.
Can Manufacturers and Wholesalers Use GTIN Instead of NDC in the Human Readable Part of the Product Identifier?
No, the use of GTIN alone as an identifier is discouraged due to the increased risk of misidentification compared to the more user-friendly 3-digit format of NDC. However, GTIN can be included voluntarily alongside NDC if it is already present on the label.
Do Product Identifier Requirements Apply to Prescription Medications Marketed Without FDA Approval?
Yes, such medications are subject to product identifier requirements under the DSCSA. Manufacturers must submit their product identifier as part of the product labeling for registration, regardless of FDA approval status.
Is It Acceptable to Use a 2D Matrix Barcode Instead of a Required Linear Barcode?
No, the draft guidance specifies the types of product packaging and the appropriate type of product identifier to be affixed. For example, a 60-count bottle of tablets would require a 2D data matrix barcode, while a homogenous case of 10 bottles, each containing 100 capsules, would necessitate a linear barcode or 2D data matrix.
Can a Manufacturer or Repackager Request a Waiver, Exemption, or Exception from the Product Identifier Requirements?
Yes, the FDA holds the authority to grant waivers, exceptions, or exemptions from DSCSA product identifier requirements. Parties interested in seeking such relief should refer to the guidance titled “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act” for detailed information and instructions.
How Can Serialization and Traceability Processes Required by the DSCSA be Simplified?
Entrusting the serialization and traceability processes to a reliable partner offering comprehensive traceability and serialization software solutions can streamline compliance with DSCSA requirements. Such partners handle the intricacies and stresses of compliance, allowing pharmaceutical supply chain businesses to focus on their operations with confidence.
Keywords:#DSCSA #pharma #compliance #drugsupplychain #FDA #serialization #traceability #pharmaceuticals #regulations #supplychainsecurity
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