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The Drug Supply Chain Security Act: Improving the Integrity of Drug Distribution—2018 Update

Introduction

The Drug Supply Chain Security Act (DSCSA) is one of two titles that comprise the Drug Quality and Security Act (DQSA) which was signed into law by President Obama on November 27, 2013.1 The DQSA purpose is to address issues related to drug compounding oversight, and incorporates a national prescription drug “track and trace” system inclusive of standards for prescription drug wholesale distributors and third-party logistics providers (3PLs). It amends the Food, Drug & Cosmetic Act (FDC). Title 1 of the DQSA addresses the compounding provisions through the Compounding Quality Act (CQA). The impetus behind the CQA was contaminated compounded drugs that led to the death of more than 60 people and infected more than 750 patients in the fall of 2012. Title 2 of the DQSA is the DSCSA, creates a uniform, national standard for tracing pharmaceuticals through the supply chain. The DSCSA calls for implementing a new electronic, interoperable system for product tracking and tracing, over a 10-year period from the date it was signed into law through November 27, 2023.2 The goal is to enhance the Food and Drug Administration’s (FDA) ability to help protect consumers by detecting and removing potentially dangerous products from the pharmaceutical distribution supply chain. In addition, the law’s immediate preemption provision eliminates the burdensome patchwork of state pedigree laws. Wholesale distributors can start conducting business the same way in all 50 states.

Drug Supply Chain

The drug supply chain in the United States, from raw source materials to finished products for consumers, has multiple opportunities for the product to be contaminated, diverted, or otherwise adulterated. National efforts related to supply chain security began in 1987, through the Prescription Drug Marketing Act (PDMA). Legal challenges to the PDMA forced a delay in implementation of federal law prompting some states to move ahead on creating their own requirements for product tracking and tracing, often referred to as “drug pedigrees.” In particular, California’s pedigree law drew the most attention nationwide due to its comprehensive requirements that included those for an electronic pedigree, product serialization, and track-and-trace capability from manufacturer to point of sale. These requirements were expected to be implemented in 2015 and concern was expressed about the exponential amount of data that would need to be maintained by each supply chain stakeholder. The cost of compliance was expected to be very high.

The DSCSA overrides the patchwork of pedigree laws in the states by creating national traceability requirements. The Act “immediately” preempts any/all state requirements that differ from the federal language. It begins an evolution to lot-based tracing then to serialized item traceability over the next 10 years that impacts all supply chain members: manufacturers, wholesalers, 3PLs, repackagers and dispensers. The DSCSA also established federal licensure standards for wholesalers by setting both “floor” and “ceiling” requirements that states must follow to license wholesalers. It also creates a federal license for states that opt not to conform and license wholesalers on their own. The pharmacist and pharmacy technician should check with their individual state board of pharmacy or regulatory body to determine what their state’s licensing requirements are for wholesaler distributors.

The FDA notes that the DSCSA will:

  • enable verification of the legitimacy of the drug product identifier down to the package level;
  • enhance detection and notification of illegitimate products in the drug supply chain; and
  • facilitate more efficient recalls of drug products.2

According to the FDA, the key provisions that will be implemented over the next 10 years are requirements for:

  • Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
  • Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market.
  • Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
  • Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
  • Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
  • Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database.
  • Third-party logistics provider licensing: Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.

DSCSA Timeline Milestones

The timeline for DSCSA is in stages over 10 years beginning with the Act’s passage date of November 27, 2013. The important dates for dispensers within the stages are summarized below. 2,3 In many cases, the FDA has published guidances on a delayed basis and as a result, delayed enforcement of many of the Act’s requirements.

DSCSA Timeline Milestones and Status

November 27, 2013 - DSCSA signed into law

January 1, 2015 - Manufacturers and distributors send and receive transaction history/transaction information/transaction statement (TH/TI/TS). The FDA delayed enforcement of this requirement until May 2015. Suspect and illegitimate product requirements effective Trading partners must be licensed and authorized.

July 1, 2015 - Dispensers receive TH/TI/TS, capture information, and maintain documentation for 6 years. The FDA delayed enforcement of this provision until March 1, 2016.4

November 27, 2015 - National standards for TH/TI/TS in paper and electronic format, and waiver, exceptions, exemptions, and grandfathered guidance published by FDA. A draft guidance was published in March 2, 2018.5

November 27, 2017 - Manufacturers must have all product serialized. FDA delayed enforcement of this provision for one year until November 26, 2018.6

November 27, 2018 - Repackagers must have all product serialized.

November 27, 2019 - Wholesalers must only engage in transactions with serialized product.

November 27, 2020 - Pharmacy lot-level traceability. Dispensers must only engage in transactions with serialized product.

November 27, 2023 - Unit-level traceability required.

Product Scope

Which products are subject to the DSCSA traceability requirements? All prescription drugs in finished dosage forms for human use are subject to the DSCSA traceability rules which begin with the manufacturer and include the direct purchase repackager and exclusive distributor as the start of the supply chain. The chain of product ownership, rather than possession, is what is tracked through the entire supply chain and transaction detail must be presented at the point of product receipt. The DSCSA does exclude numerous products which are listed in Table 1.

Table 1. Products Not Covered by DSCSA2
OTC medications
Medical devices
Animal use drugs
Blood or blood components intended for transfusion
Radioactive drugs or biologics
Imaging drugs
Certain IV products: those intended for fluid and electrolyte replenishment (e.g., sodium, chloride, potassium) or calories (e.g., dextrose and amino acids); those used to maintain equilibrium of water and minerals in body (e.g., dialysis solution); and those intended for irrigation or sterile water.
Medical gas
Homeopathic drugs
Lawfully compounded drugs

Definitions

In order to understand requirements placed on each supply chain partner, it is important to understand how the DSCSA defines each partner. Under the Act, a manufacturer is 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, or a co-licensed partner that obtains the product directly, or an affiliate. A wholesale distributor is a person (other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider or repackager) engaged in wholesale distribution (as defined in the DSCSA and FD&C Act). Wholesale distribution is distribution of an Rx product to an entity/person other than the patient.

Dispensers include:

  • A retail pharmacy
  • A 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.2

Authorized Trading Partners are manufacturers and repackagers with a valid registration with FDA. Wholesale distributors with a valid state or federal license and compliance with reporting requirements; considered authorized before federal licensing regulations effective if possesses “valid license under state law”. Third-party logistic providers with a valid state or federal license and compliance with reporting requirements; considered authorized before federal licensing regulations effective, unless FDA makes certain findings and gives notice. And, dispensers (pharmacies) with a valid state license.

Product Tracing and Transaction Information

Beginning on January 1, 2015, manufacturers, wholesale distributors, repackagers were required to provide transaction documentation with products. As of July 1, 2015, dispensers were required to comply with the provisions of the DSCSA for the tracing of products through the pharmaceutical distribution supply chain although the dispenser requirement was not enforced until March 1, 2016.4

The transaction records that are part of the DSCSA’s tracing and tracking requirements are three-fold: Transaction History (TH) which refers to who has owned the product. Transaction Information (TI) which refers to product information such as a product description, NDC number, Lot number, number of containers, etc. and Transaction Statement (TS) which is a statement attesting to a transaction being correct and that the information is accurate.

Transaction Information or TI includes the following:

  • Proprietary or established name or names of the product;
  • Strength and dosage form of the product;
  • National Drug Code number of the product;
  • Container size;
  • Number of containers;
  • Lot number of the product;
  • Date of the transaction;
  • Date of the shipment, if more than 24 hours after the date of the transaction; and
  • Business name and address of the person from whom and to whom ownership is being transferred.5

The pharmacist and pharmacy technician should note that the lot number, transaction date and shipment date are not required for sale of direct purchase products—these are products that the pharmacy purchases from a wholesale distributor who in turn purchased the product directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager that purchased directly from the manufacturer.2 The lot number, transaction date and shipment date would be required if the pharmacy purchased a product from Distributor Y who in turn had purchased the product from Distributor X who purchased the product directly from the manufacturer.

The TH is a statement in electronic or paper form that includes the TI for each prior transaction going back to the manufacturer of the product. The TS attests that the transaction statement entity did not knowingly ship a suspect or illegitimate product; had systems and processes in place to comply with verification requirements under the law; did not knowingly provide false transaction information; and did not knowingly alter the transaction history.

So, as a general rule, each seller must provide the TI, TH and TS to the subsequent owner for each transaction and each buyer must store the TI, TH and TS it receives. These records must be store by each for a period of six years.

Use of Third Parties for Dispenser Transaction Data

The majority of wholesaler distributors and buying groups created systems to store a dispenser’s purchasing data through web-based portals. The dispensers may enter business agreements to use these systems but it is important these agreements ensure the transaction documents are stored for six years and that the information can be accessed in 48 hours in the event of the dispenser is audited by the FDA (wholesaler distributors must produce documentation within 24 hours in the event of an FDA audit). It is not clear, however, that if a dispenser switches to a different wholesale distributor or buying group whether the initial wholesaler distributor and/or buying group will continue to maintain the transaction documentation or make it accessible. Some may choose to provide paper or electronic reports that the dispensing pharmacy will now need to create a system to store and access them for six years. Additionally, in the event of an audit, the dispenser is required to store all audit-related documents for up to six years after the audit.2

The FDA has indicated that dispensers may enter into a written agreement with a third party, including an authorized wholesale distributor, under which the third party confidentially maintains the product tracing information on the dispenser’s behalf. FDA considers authorized trading partners and entities that are not authorized trading partners to be acceptable third parties for this purpose. When such an arrangement exists, the dispenser must maintain a copy of the written agreement.5

The FDA recognizes that a dispenser that has entered into this type of agreement may request that the trading partner that sells product to the dispenser provide the product tracing information directly to the third-party. Pursuant to such request from the dispenser, the trading partner that is transferring ownership to the dispenser has met its obligation to provide product tracing information, and the dispenser has met its obligation to capture and maintain product tracing information for the transaction by providing this information directly to the third-party.

Returns are also governed by DSCSA requirements. For saleable returns, a dispenser may return product to the trading partner they purchased the product from without providing the requisite information. For non-saleable returns, a dispenser may return product to the manufacturer or repackager, to the wholesale distributor from whom the product was purchased, to a returns processor, or to a person acting on their behalf without providing the requisite information. However, by 2019, wholesale distributors must only accept returns that contain the required product identifier (see implementation timeline) before redistributing returned products.

Exceptions to DSCSA Tracing Requirements

There are several exceptions to the DSCSA tracing requirements. These include:

  • Intracompany distribution of any product between members of an affiliate or within a manufacturer.
  • Distribution of product between hospitals or healthcare entities under common control.
  • Distribution of product for emergency medical reasons, which includes a public health emergency, and excludes a drug shortage unless caused by such a public health emergency.
  • Distribution of minimal quantities by a licensed retail pharmacy or licensed practitioner for office use. What minimal quantities means is not defined. Many states define this as 5% or less of a pharmacy’s sales. The pharmacy technician should check with their state board of pharmacy or appropriate regulatory body.
  • Dispensing pursuant to a prescription.
  • Pharmacy sale to another pharmacy for a “specific patient need.” A special patient need means an identified patient exists and does not include transfers “for the purpose of increasing or replenishing…in anticipation of a potential need.”2

There are some complexities associated with the DSCSA as well. One is the exception to the lot number and transaction dates noted earlier related to direct purchase. Secondly, drop shipments are required to have TI, TH and TS provided to the shipper NOT the distributor. In addition, a 340B Covered Entity is considered the purchaser, not the contracted pharmacy that may be providing services. As such, the 340B Covered Entity will receive the transaction documentation instead of the contract pharmacy.

Verification

As of January 1, 2015, all trading partners, including dispensers must notify FDA and certain immediate trading partners, when it is determined that a product in its possession or control is a suspect or illegitimate product not later than 24 hours after making the determination. All trading partners must have systems in place that enable them, upon determining that a product in their possession or control is suspect or upon receiving a request for verification from the FDA, or other appropriate federal or state official, to quarantine suspect product and promptly conduct an investigation, in coordination with other trading partners, as applicable, to determine whether a product is illegitimate. Dispensers must be able to respond to verification requests made by the Secretary of HHS about suspect product within 2 business days. The FDA issued definitions of what it considers suspect product through a draft guidance on March 2, 2018.7

The FDA issued a final Guidance on Identifying Suspect Product and Notification on December 9, 2016.8 The Guidance provides information that trading partners, including dispensers, should take into consideration when developing policies and procedures and revolves around three specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution chain that might increase risk which should be mitigated and/or reviewed. These scenarios are:

  • Product Sourcing
  • Supply, Demand, History, and Value of the Product; and,
  • Product Appearance

The scenarios that are featured in the guidance are based on the FDA’s past experience with suspect product in the drug supply chain. They note the examples are “illustrative and should be viewed as guidance rather than as an exhaustive list of all potential scenarios” that may increase the likelihood that a suspect product could enter the pharmaceutical distribution supply chain. For these scenarios, pharmacists & pharmacy technicians should be particularity vigilant. Information for each scenario below is taken directly from the FDA guidance document.

1. Product Sourcing

  • Purchasing from a source new to the trading partner.
  • Receiving an unsolicited sales offer from an unknown source. Trading partners might receive unsolicited offers or advertisements through an email, a fax, a telephone call, or an in-person sales call from a person or entity with whom they do not have an established business relationship.
  • Purchasing on the Internet from an unknown source. Trading partners might be searching for a better price on the Internet or for a product that they cannot obtain from their usual source, and might be tempted to turn to a person or entity with whom they do not have an established business relationship.
  • Purchasing from a source that a trading partner knows or has reason to believe has transacted business involving suspect products, such as:
    • A trading partner that has been involved in business transactions where they sold or delivered suspect or illegitimate product.
    • A trading partner that has a history of problematic or potentially false transaction histories or pedigrees, such as those that contain misspelled words or incomplete information.
    • A trading partner that is reluctant to provide a transaction history or pedigree associated with the product being purchased, or does not do so in a timely manner.
    • Transaction information, a transaction statement, and/or transaction history that appears to be incomplete or suspicious.

2. Supply, Demand, History, and Value of the Product

3. Product Appearance

  • Appearance of a package or a container used for transport (e.g., case or tote) that seems suspicious (e.g., it has a label that contains misspellings or appears different from the standard label for that product in color, font, images, or otherwise).
  • Package that exhibits unusual or excessive adhesive residue.
  • Package that uses foreign terms, such as a different drug identification number rather than the National Drug Code (NDC).
  • Package that is missing information, such as the lot number or other lot identification, or the expiration date.
  • Package that is missing anti-counterfeiting technologies normally featured on the FDA-approved product that are easily visible to the eye, such as holograms, color shifting inks, or watermarks.
  • Finished dosage form that seems suspicious (e.g., it has a different shape or color from the FDA-approved product, a different or unusual imprint, an unusual odor, or there are signs of poor quality like chips or cracks in tablet coatings or smeared or unclear ink imprints).

The pharmacists and pharmacy technician can play an important role in helping to identify suspect product by using several strategies that the FDA recommends in the guidance. In particular, the pharmacist should be alert for offers of product for sale at a very low price or one that is “too good to be true.” When receiving product, the pharmacy technician should closely examine the package and the transport container (such as the case or tote) to:

  • Look for signs that it has been compromised (e.g., opened, broken seal, damaged, repaired, or altered).
  • See if it has changed since it was last received for an unexplained reason (e.g., a notification about the change from the manufacturer has not been received).
  • See if product inserts are missing or do not correspond to the product.
  • For shipping addresses, postmarks, or other materials indicating that the product came from an unexpected foreign entity or source.

When removing product from the case or tote, the pharmacy technician should closely examine the label on the package or on the individual retail unit and determine if there is:

  • Any missing information, such as the lot number or other lot identification, NDC, or strength of the drug.
  • Any altered product information, such as smudged print or print that is very difficult to read.
  • Misspelled words.
  • Bubbling in the surface of a label.
  • Lack of an Rx symbol.
  • Foreign language with little or no English provided.
  • Foreign language that is used to describe the lot number.
  • A product name that differs from the name of the FDA-approved drug.
  • A product name that is the product name for a foreign version of the drug.
  • A product that is transported in a case or tote, when not expected under the circumstances.
  • Lot numbers and expiration dates on product that do not match the lot numbers and expiration dates of its outer container5

If a product is identified as illegitimate, the dispenser should follow the reporting process outlined in the guidance:

  1. Access FDA’s Web page at: http://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm for notifications.
  2. Follow the instructions on the Web page for accessing Form FDA 3911. Using this form, provide information about the person or entity initiating the notification, the product determined to be illegitimate that is the subject of the notification to FDA, and a description of the circumstances surrounding the event that prompted the notification.

The FDA will acknowledge receipt of the notification and assign an incident number. That number should be referenced in all future correspondence about the illegitimate product, including any request for termination.

In addition to notifying FDA, the trading partner that determines it has an illegitimate product in its possession or control must notify all immediate trading partners that it has reason to believe may also possess the drug. The FDA says this can be done using existing systems and processes used for similar types of communications to those partners, which might include, but are not limited to, posting of notifications on a company Web site, telephoning, sending an email, or mailing or faxing a notification.5

Verification requirements will change once products are serialized.

Product Identifier & Grandfathering

The requirement for manufacturers to serialize product went into effect on November 27, 2017 and for repackagers on November 27, 2018. However, the FDA delayed enforcement of the product ID requirements through November 26, 2018.9 This means that each product must have an affixed or imprinted product identifier on each package and homogenous case of a product. Importantly, a drug product will be considered misbranded if it does not have this unique identifier. The identifier must be human- and machine-readable. Each product identifier should include: the product’s NDC number, serial number, lot number, and expiration date. Wholesaler distributors will need to be able to track serialized product beginning November 27, 2019 while dispensers will need to by November 27, 2020. In essence, after November 27, 2020 only products that have the product identifier will be able to be legally traded.2

The FDA’s Guidance on Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier10 exempts manufacturers, repackagers, wholesale distributors and dispensers from verifying products using the product identifier if the product or homogeneous case was packaged by a manufacturer or repackaged by a repackager before November 27, 2018.

FDA Required Activities

The DSCSA also sets forth some required activities that the FDA must conduct.2 The Agency has to assess both technology and software to see how feasible it is for small pharmacies to do product tracing at the package level by 2020 since it is uncertain what the cost of the technology and software will be for pharmacies in order to scan the serialized product bar codes. The FDA must also establish pilot projects in coordination with stakeholders to explore and evaluate methods to enhance supply chain safety and security by 2020. The pilot projects will be designed to utilize the product identifier for product tracing, improve technical capabilities and identify system attributes needed to implement security requirements. Further, they must develop regulations establishing an enhanced drug distribution security system for interoperable product tracing at the package level by 2021 and publish final guidance on standards for this interoperable system by 2022.

Summary

The DSCSA will help protect consumers by improving detection and removal of potentially dangerous products from the pharmaceutical distribution supply chain. The pharmacists and pharmacy technician working within a dispensing pharmacy will need to be aware of the DSCSA requirements and be able to assist with their implementation. The pharmacist and pharmacy technician should be able to use the FDA guidance documents to assist with compliance. A list of important DSCSA resources follows which should allow the pharmacist and pharmacy technician to remain current on DSCSA guidance.

DSCSA Resources

FDA Drug Security and Quality Act of 2013, Title II, Drug Supply Chain Security Act: http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainse curityact/ucm376829.htm

Drug Supply Chain Security Act http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainS ecurityAct/default.htm

FDA Timeline for Implementing the DSCSA: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChain SecurityAct/ucm382022.htm

FDA Guidance on Identifying Suspect Product and Notification: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM400470.pdf

FDA Guidance: DSCSA Implementation: Product Tracing Requirements – Compliance Policy http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM427867.pdf

FDA Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM565272.pdf

FDA Guidance: Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM586509.pdf

FDA Website: Are you ready for the Drug Supply Chain Security Act? http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChain SecurityAct/ucm427033.htm

FDA Website: Know Your Source: Protecting Patients from Unsafe Drugs http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm

FDA Website: Counterfeit Drugs

http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/co unterfeitmedicine/default.htm

FDA Email Contacts: DrugTrackandTrace@fda.hhs.gov; and CDERDrugSupplyChainIntegrity@fda.hhs.gov

References

  1. Oversight of the U.S. Drug Supply. National Conference of State Legislatures Website. October 1, 2014. http://www.ncsl.org/research/health/regulation-and-oversight-of-the-u-s-drug-supply-h-r-3204-the-drugquality-and-security-act.aspx. Accessed October 21, 2018.
  2. Title II of the Drug Quality and Security Act. The FDA Website. December 16, 2014. http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainsecurityact/ucm 376829.htm. Accessed October 21, 2018.
  3. Pharmaceutical Traceability. The Healthcare Distribution Management Association (HDMA) Website. https://www.hda.org/issues/pharmaceutical-traceability. Accessed October 21, 2018.
  4. DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised). FDA Guidance. November 2, 2015. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM453225.pdf. Accessed October 21, 2018.
  5. Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry. FDA Draft Guidance. March 2, 2018. file:///C:/Users/Marsha/Documents/PowerPak/TrackTraceCE/TrackTraceCE/2018/UCM598734.pdf. Accessed October 21, 2018.
  6. Rodgers D. FDA Delays Enforcement of DSCSA November Deadline: What It Means. RxTrace Website. July 3, 2017. https://www.rxtrace.com/2017/07/fda-delays-enforcement-dscsa-november-deadlinemeans.html/. Accessed October 21, 2018.
  7. Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act. FDA Website. March 2, 2018. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM598737.pdf. Accessed October 21, 2018.
  8. FDA Guidance on Identifying Suspect Product and Notification. FDA Website.December 9, 2016. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM400470.pdf. Accessed October 21, 2018.
  9. Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. FDA Website. September 20, 2018. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM565272.pdf. Accessed October 21, 2018.
  10. Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier. FDA Website. September 20, 2018. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM586509.pdf. Accessed October 21, 2018.

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