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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 One purpose of the DQSA is to address issues related to drug compounding oversight. The DQSA also incorporates a national prescription drug "track and trace" system inclusive of standards for prescription drug wholesale distributors and third-party logistics providers (3PLs). The DQSA amends the Food, Drug, and Cosmetic Act (FDCA). Title 1 of the DQSA addresses compounding provisions through the Compounding Quality Act (CQA). The impetus for the CQA was the contamination of compounded drugs that led to the deaths of more than 60 people and infections in more than 750 patients in the fall of 2012. Title 2 of the DQSA is the DSCSA and it 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.² The goal of the DSCSA is to enhance the U.S. Food and Drug Administration's (FDA) ability to help protect consumers by detecting and removing potentially dangerous products from the pharmaceutical distribution supply chain. Additionally, 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 (U.S.), from raw source materials to finished products for consumers, has multiple opportunities for products to be contaminated, diverted, or otherwise adulterated. National efforts related to supply chain security began in 1987 with the Prescription Drug Marketing Act (PDMA). Legal challenges to the PDMA forced a delay in implementation of federal law, which prompted some states to create their own requirements for product tracking and tracing, often referred to as "drug pedigrees." Nationwide, California's pedigree law drew the most attention because of its comprehensive requirements that included 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. Concern was expressed about the substantial amount of data that would have to be maintained by each supply chain stakeholder and the cost of compliance was expected to be very high.²

The DSCSA overrides the patchwork of pedigree laws in the states by creating national traceability requirements. The DSCSA immediately preempts any and all state requirements that differ from the federal language. It begins the transitions to lot-based tracing and then to serialized item traceability over a 10-year period that impact all of the following supply chain members: manufacturers, wholesalers, 3PLs, repackagers, and dispensers. The DSCSA also establishes federal licensure standards for wholesalers by setting 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. Pharmacists and pharmacy technicians should check with their individual state boards of pharmacy or regulatory bodies to determine what each state's licensing requirements are for wholesale distributors.²

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
• Facilitate more efficient recalls of drug products²

According to the FDA, the key provisions of the DSCSA that will be implemented over the next 10 years are requirements for the folllowing:²

• Product identification: Manufacturers and repackagers must put a unique product identifier on certain prescription drug packages; for example, a bar code could be used that can be easily read electronically.
• Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain must 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) must establish systems and processes to verify the product identifier on certain prescription drug packages.
• Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) must 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) must establish systems and processes to notify the FDA and other stakeholders if an illegitimate drug is found.
• Licensing of wholesalers: Wholesale drug distributors must report their licensing status and contact information to the FDA. This information will then be made available in a public database.
• Licensing of 3PLs: Entities that provide storage and logistical operations related to drug distribution must obtain a state or federal license.

DSCSA Timeline Milestones

The implementation timeline for the DSCSA is divided into several stages over a 10-year period, beginning with the Act's passage on November 27, 2013. The important dates for dispensers within the stages are summarized below.^2,3

November 27, 2013: DSCSA signed into law.

January 1, 2015: Manufacturers and distributors send and receive tracking and tracing documentation. (The FDA intended to begin enforcing this on May 1, 2015.) Suspect and illegitimate product requirements became effective. Trading partners must be licensed and authorized.

July 1, 2015: Dispensers receive tracking and tracing documentation, capture information, and maintain documentation for 6 years.

November 27, 2015: National standards established for tracking and tracing documentation in paper and electronic format, and waivers, exceptions, exemptions, and grandfathered guidance published by FDA.

November 27, 2017: Manufacturers must have all product serialized.

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 required. Dispensers must only engage in transactions with serialized product.

November 27, 2023: Unit-level traceability required.

Product Scope

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 tracked through the entire supply chain and transaction detail must be presented at the point of product receipt. The DSCSA excludes numerous products, which are listed in Table 1.²

Table 1. Products Not Included in the DSCSA2

Over-the-counter medications Medical devices Drugs for use in animals Blood or blood components intended for transfusion Radioactive drugs or biologics Imaging drugs Certain intravenous products, such as those intended for fluid and electrolyte replenishment (e.g., sodium, chloride, and 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

To understand requirements placed on each supply chain partner, it is important to understand how the DSCSA defines each partner. Under the DSCSA, 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; if such product is not the subject of an approved application or license, the manufacturer is defined as the person who manufactured the product, 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) who is engaged in wholesale distribution (as defined in the DSCSA and FDCA). Repackager is defined as “a person who owns or operates an establishment that repacks and relabels a product or package for – (A) further sale; or (B) distribution without a further transaction.” A 3PL is "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." Importantly, 3PLs do not take ownership of the product, nor have responsibility to direct the sale or disposition of the product. Wholesale distribution is the distribution of a prescription product to an entity or a person other than the patient. A dispenser is an entity that is authorized to dispense or administer prescription drugs and the affiliated warehouses or distribution centers of such entities. Examples of dispensers include the following:

• A retail pharmacy
• A hospital pharmacy
• A group of chain pharmacies under common ownership and control that does not act as a wholesale distributor
• Any other person authorized by law to dispense or administer prescription drugs
• Affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor²

Authorized trading partners are manufacturers and repackagers with a valid registration with the FDA. Wholesale distributors with a valid state or federal license and compliance with reporting requirements are also authorized trading partners; these partners are considered authorized before federal licensing regulations are effective if they possess a valid license under state law. 3PLs with a valid state or federal license and compliance with reporting requirements are also authorized trading partners; they are considered authorized before federal licensing regulations are effective, unless the FDA makes certain findings and gives notice. Dispensers (pharmacies) with a valid state license are also considered authorized trading partners.

Product Tracing and Transaction Information

Beginning on January 1, 2015, manufacturers, wholesale distributors, and repackagers were required to provide tracking and tracing documentation with each product transaction. As of July 1, 2015, dispensers were required to comply with the provisions of the DSCSA for the tracing of products through the drug supply chain.

The transaction records that are part of the DSCSA's tracking and tracing requirements include the following 3 components: transaction history (TH), which refers to who has owned the product; transaction information (TI), which refers to product description or other identifiable information; and transaction statement (TS), which is a statement attesting that the transaction is correct and that the information is accurate. TI includes the following components:

• Proprietary or established name or names of the product
• Strength and dosage form of the product
• National Drug Code (NDC) number of the product
• Container size
• Lot number of the product
• Date of the shipment, if more than 24 hours after the date of the transaction
• Business name and address of the person from whom and to whom ownership is being transferred²

The TH is a statement in electronic or paper form that includes the TI for each prior transaction, beginning with the manufacturer of the product. The TS attests that the 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.²

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 that it receives. These records must be store by each trading partner for a period of 6 years.²

The pharmacist and pharmacy technician should note that the lot number, transaction date, and shipment date are not required for the sale of direct purchase products, which are products that the pharmacy purchases from a wholesale distributor who 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 had purchased the product from Distributor X who had purchased the product directly from the manufacturer.

The majority of wholesale distributors and buying groups are creating 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 that these agreements ensure the transaction documents are stored for 6 years and that the information can be accessed within 48 hours in the event the dispenser is audited by the FDA. (Wholesale distributors must produce documentation within 24 hours in the event of an FDA audit.) It is not clear, however, if the initial wholesale distributor and/or buying group will continue to maintain the transaction documentation or make it accessible when a dispenser changes to a different wholesale distributor or buying group. Some trading partners may choose to provide paper or electronic reports; dispensing pharmacies must create systems to store and access this documentation for 6 years. Additionally, in the event of an audit, the dispenser is required to store all audit-related documents for up to 6 years after the audit.²

Product returns are also governed by DSCSA requirements. For saleable returns, a dispenser may return product to the trading partner from whom they purchased the product 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.²

Exceptions to DSCSA Tracing Requirements

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

• Intracompany distribution of any product between members of an affiliate or within a manufacturer
• Distribution of product between hospitals or health care 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. ("Minimal quantities" is not defined by the DSCSA, but many states define this as 5% or less of a pharmacy's sales. Pharmacists and pharmacy technicians should check with their state boards of pharmacy or appropriate regulatory bodies to verify the definition of "minimal quantities")
• Dispensing pursuant to a prescription
• Pharmacy sale to another pharmacy for a "specific patient need." A specific patient need means that an identified patient exists; it does not include transfers for the purpose of increasing or replenishing the quantity of a product in anticipation of a potential need²

There are some complexities associated with the DSCSA: One exception is to the lot number and transaction dates noted previously that are related to direct purchase. Second, drop shipments are required to have TI, TH, and TS provided to the shipper, not to 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.²

Enforcement Delay for Dispensers to Receive Transaction Documentation

Because many dispensers were not aware or ready to comply with the DSCSA provisions for tracing, on June 30, 2015 the FDA announced that it does not intend to take action against dispensers who, prior to November 1, 2015, accepted ownership of product without receiving the product tracing information required by the DSCSA.⁴ This compliance policy does not extend to the requirements that other trading partners (manufacturers, wholesale distributors, and repackagers) provide product tracing information to dispensers. In addition, this compliance policy does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information, including TH. In the Guidance, the FDA says, "If a dispenser has not received product tracing information prior to or at the time it takes ownership of a product, FDA recommends that the dispenser work with the previous owner to receive this information. FDA believes that product tracing information serves as an important tool for dispensers to meet their obligation to identify suspect product, quarantine the product, and investigate whether that product is illegitimate."⁴

Verification

As of January 1, 2015, all trading partners, including dispensers, must notify the FDA and certain immediate trading partners when it is determined that a product in their possession or control is a suspect or illegitimate product; this notification must be made within 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 Health and Human Services about suspect product within 2 business days.²

The FDA has issued a draft of the document, FDA Guidance on Identifying Suspect Product and Notification.⁵ The Guidance provides information that trading partners, including dispensers, should consider when developing policies and procedures. The recommendations revolve around 3 specific scenarios that could significantly increase the risk of a suspect product entering the drug supply chain and 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 drug supply chain.⁵ Pharmacists and pharmacy technicians should be particularity vigilant for these scenarios. The following example scenarios are provided in the FDA guidance document.

Examples of product sourcing that may contribute to a suspect product entering the drug supply chain include the following:

• 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 they 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 the following:
  • – A trading partner that has been involved in business transactions in which 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 TH or pedigree associated with the product being purchased, or does not do so in a timely manner
  • – TI, a TS, and/or TH that appears to be incomplete or suspicious⁵

Examples of supply, demand, history, and value of the product that may contribute to a suspect product entering the drug supply chain include the following:

• Product that is generally in high demand in the U.S. market
• Product that is in higher demand because of its potential or perceived relationship to a public health or other emergency (e.g., antiviral drugs)
• Product that has a high sales volume or price in the U.S.
• Product that has been previously or is currently being counterfeited or diverted (e.g., human immunodeficiency virus, antipsychotic, or cancer drugs)
• Product that has been previously or is currently the subject of a drug shortage. (The list of current drugs in shortage is available at http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/default.htm and http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
• Product that has been or is the subject of an illegitimate product notification under the DSCSA or other alert or announcement related to drug quality
• Product that has been or is the subject of an FDA counterfeit or cargo theft alert. (More information on counterfeit and theft alerts is available at http://www.fda.gov/iceci/criminalinvestigations/ucm182888.htm.)⁵

Examples of product appearance that may contribute to a suspect product entering the drug supply chain include the following:

• 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)
• A package that uses foreign terms, such as a drug identification number that is different from the NDC
• A package that is missing information, such as the lot number or other lot identification or the expiration date
• A package that is missing anticounterfeiting technologies normally featured on the FDA-approved product that are easily visible to the eye, such as holograms, color shifting inks, or watermarks
• A 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)⁵

Pharmacists and pharmacy technicians 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 an offer that is "too good to be true." When receiving product, the pharmacy technician should closely examine the package and the transport container 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
• Look for shipping addresses, postmarks, or other materials indicating that the product came from an unexpected foreign entity or source⁵

When removing product from the transport container, 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

Verification requirements will change once products are serialized. The requirement to serialize product goes into effect on November 27, 2017 for manufacturers and on November 27, 2018 for repackagers. The serialization will be designated with a 2D bar code that contains the product's NDC number, serial number, lot number, and expiration date. Wholesale distributors will need to be able to track serialized product beginning November 27, 2019, while dispensers will need to track product by November 27, 2020. Essentially, after November 27, 2020 only products that have a product identifier will be able to be legally traded.²

Product Identifier

In the earlier timeline, it is noted that by November 27, 2017 that manufacturers must have all products serialized. This means that each product must have an affixed or imprinted product identifier on each package and homogenous case of a product that will be introduced into commerce beginning not later than November 27, 2017.⁶ 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 National Drug Code (NDC), standardized numerical identifier, lot number and expiration date.⁷ The FDA has issued guidance for industry regarding these product identifiers including compliance with policies and enforcement of these policies.⁶

FDA-Required Activities

The DSCSA also sets forth some required activities that the FDA must conduct.² The FDA 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 because it is uncertain what the cost of the technology and software will be for pharmacies 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, the FDA 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 the detection and removal of potentially dangerous products from the drug supply chain. Pharmacists and pharmacy technicians working in a dispensing pharmacy will have to be aware of the DSCSA requirements and be able to assist with their implementation. They should also be able to use FDA guidance documents to assist with compliance. Important DSCSA resources, listed in Table 2, are available that allow pharmacists and pharmacy technicians to remain current on DSCSA guidance.

Table 2. DSCSA Resources

FDA Drug Security and Quality Act of 2013, Title II, Drug Supply Chain Security Act: http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainsecurityact/ucm376829.htm Drug Supply Chain Security Act: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm FDA Timeline for Implementing the DSCSA: http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainsecurityact/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 Enforcement Discretion for Dispensers: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM453225.pdf FDA Web site: Are you ready for the Drug Supply Chain Security Act? http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm427033.htm FDA Web site: Know Your Source: Protecting Patients from Unsafe Drugs: http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm FDA Web site: Counterfeit Drugs: http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/counterfeitmedicin e/default.htm FDA Center for Drug Evaluation and Research, Small Business and Industry Assistance (CDER SBIA) Webinar on DSCSA Overview & Implementation - March 12, 2014: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm388150.htm FDA DSCSA Checklist: Iowa Pharmacy Association Web site: http://www.ipha.org/assets/docs/AM2015/aphatrackandtracecompliancechecklistforpharmacies.pdf 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 Web site. Updated October 1, 2014. http://www.ncsl.org/research/health/regulation-and-oversight-of-the-u-s-drug-supply-h-r-3204-the-drug-quality-and-security-act.aspx. Accessed September 18, 2015.
2. Title II of the Drug Quality and Security Act. The U.S Food and Drug Administration Web site. Updated December 16, 2014. http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainsecurityact/ucm376829.htm. Accessed September 18, 2015.
3. Pharmaceutical Traceability. The Healthcare Distribution Management Association (HDMA) Web site. http://www.hdmanet.org/issues/pharmaceutical-traceability. Accessed September 19, 2015.
4. FDA Gives Pharmacies Another Four Months to Comply with Track and Trace Requirements. Regulatory Affairs Professional Society Website. Updated June 30, 2015. http://www.raps.org/Regulatory-Focus/News/2015/06/30/22804/FDA-Gives-Pharmacies-Another-Four-Months-to-Comply-With-Track-and-Trace-Requirements/. Accessed September 18, 2015.
5. U.S. Food and Drug Administration (FDA) Guidance on Identifying Suspect Product and Notification. FDA Website. Updated June 2014. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM400 470.pdf. Accessed September 18, 2015.
6. FDA Issues Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. FDA website. Updated June 30, 2017. https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm565358.htm.
7. Brechtelsbauer ED, Pennell B, Durham M, et al. Review of the 2015 Drug Supply Chain Security Act. Hosp Pharm. 2016 Jun;51(6):493-500.

 

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