United States: Ready Or Not, Here It Comes! The Drug Supply Chain Security Act Requirements Are Almost Fully Upon Us. Are You Prepared?

Introduction

Drugs entering the U.S. drug supply chain can pose a threat to public health and safety, especially if they are counterfeit, stolen, or contaminated. For example, in 2008, contaminated heparin containing an active pharmaceutical ingredient sourced from a firm in China resulted in the deaths of as many as eighty-one people. Several years later, in 2012, nineteen U.S. medical practices purchased counterfeit versions of the injectable cancer drug, Avastin, which lacked the genuine drug's active ingredient, from a foreign supplier. Although no deaths were reported as a result of this incident, it spurred Congress to take action to improve the security of the U.S. drug supply.

In November 2013, Congress enacted the Drug Supply Chain Security Act (DSCSA) as part of the Drug Quality and Security Act (DQSA) to address vulnerabilities in the drug supply chain and to facilitate the tracing of certain prescription drugs in finished dosage form throughout the pharmaceutical distribution supply chain.¹ The DSCSA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding sections 581 and 582, which established, among other things, product identifier, product tracing, authorized trading partner, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers. Implementation of these requirements is intended to enable the U.S. Food and Drug Administration (FDA or Agency) to better protect consumers from counterfeit, contaminated, or stolen drugs, and better detect and remove such drugs from the U.S. pharmaceutical supply chain.

The DSCSA is being progressively phased-in. Since the legislation's enactment on November 27, 2013, many of the requirements have taken effect, while others will become effective in the next few years. This article provides an overview of DSCSA requirements currently in effect, forthcoming requirements that should be on the radar for stakeholders in the drug supply chain, lessons from recent enforcement, implications for recordkeeping, and a discussion of how technological advances may be used to enhance drug supply chain security.

Part I: DSCSA Requirements

The DSCSA created a national uniform approach to tracking, tracing, and verifying the identity and validity of prescription drugs in the U.S. supply chain. Pharmaceutical supply chain stakeholders, including drug manufacturers, wholesale distributors, repackagers, third-party logistics providers, and dispensers, are now expected to comply with many of the major provisions of the DSCSA. Since 2015, many key elements of the statute have become effective, including product track and trace requirements, use of product identifiers on packages and cases of drugs intended for use in transactions (and verifying products at the package level) by manufacturers and repackagers, implementation of verification systems that facilitate identification and quarantining of suspect/illegitimate products, and notification of trading partners and FDA of suspect/illegitimate products. Other key requirements, such as the use of product identifiers and performing verification at the product level by wholesale distributors and dispensers, as well as the implementation of an interoperable electronic unit-leveltraceability system, are forthcoming.

The charts below provide an overview of the major DSCSA requirements currently in effect and on the horizon, the supply chain stakeholders to whom they apply, and the provisions' effective dates.

DSCSA Requirements Currently in Effect

DSCSA Requirements Forthcoming

Part II: DSCSA Enforcement

On February 7, 2019, FDA issued a Warning Letter to McKesson Corporation, a wholesale drug distributor, following a Form FDA 483 issued in connection with a 2018 inspection of the firm's corporate headquarters and a distribution facility. This marks the first Warning Letter issued by the Agency citing violations of DSCSA provisions currently in effect. Not only is this Warning Letter significant because it is indicative of FDA's commitment to improving the safety of the nation's drug supply, but also because it is instructive in that it included three (non-exhaustive) examples of McKesson's non-compliance with the verification requirements of the DSCSA that are applicable to wholesale distributors. Below is an overview of the FDA's Warning Letter to McKesson, examples of the firm's non-compliance set forth in the Warning Letter, and McKesson's responses to the Form FDA 483 as conveyed in the Warning Letter.

FDA Warning Letter to McKesson Corporation

Although the DSCSA's provisions are not yet fully implemented, the FDA issued its first Warning Letter citing violations of DSCSA provisions currently in effect to McKesson Corporation on February 7, 2019.¹⁵ According to the Warning Letter, FDA observed significant violations of the DSCSA's verification requirements during its inspection of McKesson's corporate headquarters from June 25 to July 3, 2018 and a McKesson distribution center facility from June 26 to June 29, 2018. FDA subsequently issued a Form FDA 483 to McKesson Corporation on July 3, 2018.¹⁶ The verification requirements said to be at issue, and identified in the warning letter, included those that apply to wholesale distributors when they determine or are notified that a product is "suspect" or "illegitimate."¹⁷ Among the violations observed/cited during FDA's inspection were:

(1) McKesson not having systems in place to enable compliance with the DSCSA's verification requirements;

(2) McKesson not responding to illegitimate product notifications, including identifying all illegitimate products subject to such notifications and quarantining such products; and

(3) McKesson not keeping records of the investigation of suspect product and the disposition¹⁸ of illegitimate product.

The Warning Letter included three non-exhaustive examples of McKesson's non-compliance with the verification requirements of the DSCSA that apply to wholesale distributors. The following is a brief discussion of each example.

Example 1

Example 1 in the Warning Letter describes how McKesson was notified several times by various Rite Aid pharmacies of their receipt of bottles labeled as containing 100 tablets of oxycodone hydrochloride, but the seals of the bottles were broken and the bottles contained no oxycodone hydrochloride. In some instances, the bottles contained tablets of another drug product. After receiving illegitimate product notifications from Rite Aid, McKesson was required to respond by identifying all illegitimate product subject to such notification that was in its possession or control, including any product that was subsequently received.¹⁹

After such identification, McKesson was then required to quarantine illegitimate product within its possession or control from product intended for distribution until the illegitimate product was dispositioned,²⁰ dispose of any illegitimate product within its possession or control,²¹ take reasonable and appropriate steps to assist trading partners to dispose of illegitimate product not in the possession of McKesson,²² notify within twenty-four hours FDA and all immediate trading partners that may have received such illegitimate product,²³ and keep (for not less than six years) records of the disposition of illegitimate product.²⁴ According to the Warning Letter, McKesson conducted an investigation but failed to demonstrate that the firm met key statutory obligations. For example, McKesson did not demonstrate that it identified or quarantined all illegitimate product subject to notification (e.g., by searching for product with the same lot number or National Drug Code [NDC]), and failed to demonstrate that it notified its immediate trading partners that might have received product with the same lot number or NDC.²⁵ Additionally, McKesson did not provide records demonstrating the disposition of illegitimate product. FDA was also concerned that a McKesson representative stated that "incidents involving stolen or diverted controlled substances are not treated as Drug Supply Chain Security Act (DSCSA) verification events" even though DSCSA "explicitly defines illegitimate product to include 'a product for which credible evidence shows that the product is counterfeit, diverted, or stolen.'"²⁶

Example 2

Example 2 in the Warning Letter describes how McKesson was notified by Albertsons (one of its trading partners) that Albertsons received suspect products on two different occasions where the drug products at issue, divalproex and losartan, did not have lot numbers or expiration dates. Albertsons also reported these occurrences to FDA, which in turn requested that McKesson conduct verification to determine the status of the suspect products. Under the DSCSA, McKesson was required to quarantine the suspect products from the products intended for distribution until the suspect products were cleared or dispositioned, and promptly conduct an investigation of the suspect products in coordination with trading partners to determine whether the products were illegitimate.²⁷ McKesson was also required to keep records of the investigation of the suspect products for at least six years.²⁸ According to the Warning Letter, McKesson did not demonstrate that it quarantined all of the suspect products or conducted an investigation of the suspect products to determine whether they were illegitimate, and there was no evidence that any quarantine notices were sent to any of its distribution centers. McKesson also could not provide information demonstrating that quarantine checks were conducted at each of its distribution centers. From all of this, FDA determined that McKesson failed to have systems in place to enable compliance with the DSCSA's verification requirements.²⁹ Based on FDA's remarks in Example 2, especially McKesson's failure to provide information demonstrating that quarantine checks were conducted at the distribution facilities, firms should expect and be prepared to produce evidence of their DSCSA compliance when requested by FDA.

Example 3

Example 3 in the Warning Letter describes how McKesson was notified by GlaxoSmithKline (GSK) (a direct trading partner) that a pharmacy reported receiving two sealed bottles of a product labeled as Triumeq (a drug for the treatment of HIV/AIDS) that actually contained a different drug, gemfibrozil (a drug for the treatment of high cholesterol and triglyceride levels in the blood).³⁰ GSK also notified FDA regarding the illegitimate product. Once McKesson received notification from its trading partner, GSK, that an illegitimate product determination had been made, McKesson was required to identify all illegitimate product subject to such notification in McKesson's possession or control, including any product it subsequently received.³¹ McKesson was also required to quarantine the illegitimate product within its possession or control from product intended for distribution,³² disposition any illegitimate product within its possession or control,³³ and take reasonable and appropriate steps to assist trading partners to disposition illegitimate product not in McKesson's possession.³⁴ According to the Warning Letter, McKesson was unable to provide records demonstrating that it met the requirement to identify illegitimate product or subsequent requirements. Although a McKesson representative stated that McKesson examined its remaining inventory and did not identify product with the same lot number, there was no supporting evidence, such as records showing that (1) an illegitimate product notification was issued to distribution centers instructing them to conduct inventory shelf-checks for the reported lot number; (2) inventory shelf-checks were conducted at distribution centers to determine if the firm was in possession or control of the illegitimate product; or (3) a quarantine flag was placed into the firm's system to alert distribution centers in the event they received illegitimate product. As a result, FDA determined that McKesson was unable to establish if it was in possession of illegitimate product and notify trading partners as required.

McKesson's Form FDA 483 Response

Certain statements made in McKesson's response to the Form FDA 483 resonated poorly with the Agency. For example, part of McKesson's response stated that it investigated "incidents related to potential diversion and theft issues" and that "the incidents were not necessarily related to suspect or illegitimate products."³⁵ However, the Agency viewed this response as McKesson not fully understanding the definitions of suspect and illegitimate products³⁶ and its responsibilities under the DSCSA when notified of an illegitimate product by a trading partner. Additionally, McKesson stated that it planned to make procedural updates to its standard operating procedures and would be forming a product safety committee that would be responsible for coordination of all actions related to suspect or illegitimate products. Because McKesson did not supply any supporting documents or information with respect to these representations, FDA stated that it did not have enough information to conclude that future investigations of suspect or illegitimate products by McKesson would be conducted in accordance with the DSCSA, including the DSCSA's verification requirements.

Part III: Records as a Focal Point

One recurrent observation cited in FDA's Warning Letter to McKesson was the absence of records to substantiate McKesson's compliance with the DSCSA. Per the DSCSA's verification requirements, trading partners (except 3PLs) must keep records of the investigation of a suspect product for at least six years after the conclusion of the investigation.³⁷ Similarly, trading partners (except 3PLs) must keep records of the disposition of an illegitimate product for at least six years after the conclusion of the disposition.³⁸ Thus, firms should ensure not only that they have up-to-date record retention policies, but also that these policies are known, in effect, and actually being followed. In any investigation or inspection involving FDA, records are generally the focal point.

Increasingly, a majority of records are created and/or maintained electronically. At the present time, the regulatory requirements under 21 CFR Part 11³⁹ governing electronic records and electronic signatures do not seem to apply to firm-initiated electronic records created and/or maintained for purposes of the DSCSA.⁴⁰ However, firms should keep an eye out for potential Part 11 implications in the future, especially if the Agency issues regulations pursuant to the DCSCA that require the creation, maintenance, and/or submission of records. The issuance of such regulations may not be too far off given the impending requirement for product-tracing information to be exchanged through an electronic, interoperable system by November 27, 2023.

Part IV: Technological Advances & Supply Chain Accountability – The DSCSA & Blockchain

FDA has expressed an interest in the use of technologies (like the use of blockchain)⁴¹ that can help spur greater accountability for participants in the supply chain, help improve the ability to trace prescription drugs at every point in the distribution chain, and enhance drug supply chain security.⁴² In this regard, FDA (in the Federal Register of February 8, 2019) announced a pilot project program under the DSCSA, which is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of an electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States.⁴³ Launching this pilot program fulfills a DSCSA requirement for FDA to establish one or more pilot projects in coordination with relevant stakeholders to investigate and evaluate methods of improving the safety and security of the pharmaceutical distribution chain.⁴⁴ FDA accepted applications for participation in the DSCSA Pilot Project Program from February 8, 2019 through March 11, 2019.⁴⁵

Of note elsewhere in the Agency, FDA is also incorporating blockchain and other technological advances into its strategy for modernizing food safety, including its "New Era of Smarter Food Safety."⁴⁶ In this regard, blockchain can assist FDA in alerting consumers, implementing recalls, preventing illness, and improving the safety and traceability of issues in the food supply chain. FDA's efforts surrounding the New Era of Smarter Food Safety will concentrate on opportunities and actions to evaluate the use of new technologies to improve track and trace capability in the food supply chain, which is intended to both support and align with the DSCSA pilot program.

FDA has previously experimented with blockchain technology for sharing oncology-related health data and facilitating health information sharing among FDA, healthcare providers, and hospitals.⁴⁷ The welcomed expansion of new technologies into the drug supply chain reflects the Agency's forward-looking approach and interest in using technological advances to enhance supply chain integrity and improve public health.

Conclusion

There are quite a few moving parts related to the rolling implementation of the DSCSA that affect multiple parties involved with the pharmaceutical drug supply chain. A good understanding of the DSCSA, Agency guidance, and forthcoming regulations is critical to successful compliance, especially because failure to comply with the requirements of the DSCSA is a prohibited act under the FD&C Act.⁴⁸ FDA is also taking note of trading partners at varying points within the drug supply chain. Given the opioid epidemic, trading partners should expect extra scrutiny (and potential enforcement, as was the case for McKesson) with respect to transactions involving prescription drugs that are also controlled substances.⁴⁹

Footnotes

1 P.L. 113-54 (Nov 27, 2013). The DSCSA amended Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding subchapter H – Pharmaceutical Distribution Supply Chain.

2 See sections 582(b)(1), (c)(1), (d)(1), (e)(1) of the FD&C Act (21 U.S.C. § 360eee-1(b)(1), (c)(1), (d)(1), (e)(1)).

3 See sections 582(b)(3), (c)(3), (d)(3), (e)(3) of the FD&C Act (21 U.S.C. § 360eee-1(b)(3), (c)(3), (d)(3), (e)(3)).

4 The term "authorized" means, in the case of a manufacturer or repackager, having a valid registration in accordance with section 510 of the FD&C Act (21 U.S.C. § 360). In the case of a dispenser, it means having a valid license under state law. In the case of a wholesale distributor or third-party logistics provider (3PL), it means having a valid license under state law or pursuant to relevant provisions of the DSCSA. 21 U.S.C. § 360eee(2). Although there is no explicit effective date associated with the authorized status of trading partners of 3PLs, 3PLs themselves are nonetheless included in the definition of trading partners who interface (by accepting or transferring direct possession of a product) with other trading partners (e.g., manufacturers, wholesale distributors) that are subject to the requirement that their trading partners be authorized (Jan. 1, 2015). 21 U.S.C. § 360eee(23).

5 See sections 582(b)(2), (e)(2) of the FD&C Act (21 U.S.C. § 360eee-1(b)(2), (e)(2)). The term "product identifier" means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product. Section 581(14) of the FD&C Act (21 U.S.C. § 360eee(14)). Subject to further Agency guidance, product identifiers must be included in a two-dimensional data matrix barcode when affixed to or imprinted upon a package and in a linear or two-dimensional data matrix barcode when affixed to or imprinted upon a homogenous case. Section 582(a)(9)(A) of the FD&C Act (21 U.S.C. § 360eee-1(a)(9)(A)).

6 FDA extended the compliance period for manufacturers until November 27, 2018. See FDA Guidance for Industry, Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM565272.pdf.

7 The term "transaction" means the transfer of product between persons in which a change of ownership occurs. Section 581(24)(A) of the FD&C Act (21 U.S.C. § 360eee(24)(A)).

8 See sections 582(b)(4), (c)(4), (d)(4), (e)(4) of the FD&C Act (21 U.S.C. § 360eee-1(b)(4), (c)(4), (d)(4), (e)(4)).

9 See sections 582(b)(4)(A)(i)(II), (e)(4)(A)(i)(II) of the FD&C Act (21 U.S.C. § 360eee-1(b)(4)(A)(i)(II), (e)(4)(A)(i)(II)). "Standardized numerical identifier" means a set of numbers or characters used to uniquely identify each package or homogenous case that consists of the National Drug Code combined with a unique alphanumeric serial number. Section 581(20) of the FD&C Act (21 U.S.C. § 360eee(20)).

10 See section 503(e)(2)(A) of the FD&C Act (21 U.S.C. § 353(e)(2)(A)); section 584(b) of the FD&C Act (21 U.S.C. § 360eee-3(b)).

11 See sections 582(c)(2), (d)(2) of the FD&C Act (21 U.S.C. § 360eee-1(c)(2), (d)(2)).

12 See sections 582(c)(4)(A)(i)(II), (d)(4)(A)(ii) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(A)(i)(II), (d)(4)(A)(ii)) (additional requirements exist for dispensers).

13 The requirement under section 582(c)(4)(D) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(D)) for wholesale distributors to also verify saleable returned drug products prior to redistribution goes into effect on November 27, 2019. However, FDA, through issuance of its compliance policy entitled, "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product," https://www.fda.gov/media/131005/download, announced that it does not intend to take enforcement action against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier prior to further distributing returned product as required under section 582(c)(4)(D) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(D)).

14 See section 582(g) of the FD&C Act (21 U.S.C. § 360eee-1(g)).

15 FDA Warning Letter to McKesson Corporation Headquarters, Feb. 7, 2019, https://wayback.archive-it.org/7993/20190214023432/https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631088.htm.

16 See Form FDA 483, July 3, 2018, https://wayback.archive-it.org/7993/20190214023435/https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM616533.pdf (last accessed May 20, 2019).

17 See sections 581, 582(c)(4) of the FD&C Act (21 U.S.C. § 360eee, 360eee-1(c)(4)).

18 "Disposition" means, with respect to a product within the possession or control of an entity, 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. Section 581(4) of the FD&C Act (21 U.S.C. § 360eee(4)).

19 See section 582(c)(4)(B)(iii) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(B)(iii)).

20 See section 582(c)(4)(B)(i)(I) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(B)(i)(I)).

21 See sections 581(8), 582(c)(4)(B)(i)(II) of the FD&C Act (21 U.S.C. § 360eee(8), 360eee-1(c)(4)(B)(i)(II)).

22 See section 582(c)(4)(B)(i)(III) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(B)(i)(III)).

23 See section 582(c)(4)(B)(ii) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(B)(ii)).

24 See section 582(c)(4)(B)(v) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(B)(v)).

25 FDA found this failure particularly "troubling" since the results of the investigation suggested that the oxycodone hydrochloride was likely replaced with different product at a McKesson distribution center.

26 See supra note 23.

27 See section 582(c)(4)(A)(i) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(A)(i)).

28 See section 582(c)(4)(A)(iii) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(A)(iii)).

29 See section 582(c)(4) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)).

30 Such product is "illegitimate" within the meaning of section 581(8) of the FD&C Act (21 U.S.C. § 360eee(8)) because it is "otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans." Products unfit for distribution refers to those products whose sale would violate the FD&C Act and includes products that are suspect or illegitimate, adulterated, or misbranded. See FDA Draft Guidance for Industry, Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act, Mar. 2018, https://www.fda.gov/media/111468/download.

31 See section 582(c)(4)(B)(iii) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(B)(iii)).

32 See sections 582(c)(4)(A)(i)(I), (c)(4)(B)(i)(I) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(A)(i)(I), (c)(4)(B)(i)(I)).

33 See section 582(c)(4)(B)(i)(II) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(B)(i)(II)).

34 See section 582(c)(4)(B)(i)(III) of the FD&C Act (21 U.S.C. § 360eee-1(c)(4)(B)(i)(III)).

35 See FDA Warning Letter to McKesson Corporation, Feb. 7, 2019 at "Corrective Actions".

36 An "illegitimate product," among other things, is a product for which credible evidence shows that the product is counterfeit, diverted, or stolen. Section 581(8) of the FD&C Act (21 U.S.C. § 360eee(8)). A "suspect product," among other things, is a product for which there is reason to believe that such product is potentially counterfeit, diverted, or stolen. Section 581(21) of the FD&C Act (21 U.S.C. § 360eee(21)).

37 Sections 582(b)(4)(B)(v), (c)(4)(B)(v), (d)(4)(B)(v), (e)(4)(B)(v) of the FD&C Act (21 U.S.C. § 360eee-1(b)(4)(B)(v), (c)(4)(B)(v), (d)(4)(B)(v), (e)(4)(B)(v)).

38 Sections 582(b)(4)(A)(iii), (c)(4)(A)(iii), (d)(4)(A)(iv), (e)(4)(A)(iii) of the FD&C Act (21 U.S.C. § 360eee-1(b)(4)(A)(iii), (c)(4)(A)(iii), (d)(4)(A)(iv), (e)(4)(A)(iii)).

39 In March of 1997, FDA issued final Part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. 62 Fed. Reg. 13,464 (March 20, 1997). These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health. Id.

40 Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. 21 C.F.R. § 11.1(b). This Part also applies to electronic records submitted to the Agency under requirements of the FD&C Act and the Public Health Service Act, even if such records are not specifically identified in Agency regulations. Id.

41 A blockchain is a continuously growing list of records, called blocks, which are linked and secured using cryptography. See e.g., https://en.wikipedia.org/wiki/Blockchain (last accessed April 30, 2019). It is an open, distributed ledger that can record transactions between two parties efficiently and in a verifiable and permanent way. Id. Each block typically contains a cryptographic hash of the previous block, a timestamp, and transaction data. Id. By design, a blockchain is inherently resistant to modification of the data. Id.

42 See FDA News Release, FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines, Feb. 7, 2019, https://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-adopt-more-modern-technologies-improving-security-drug-supply-chain-through.

43 84 Fed. Reg. 2880.

44 Id.

45 Id.

46 FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on new steps to strengthen FDA's food safety program for 2020 and beyond, Mar. 19, 2019, https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-deputy-commissioner-frank-yiannas-new-steps. See also FDA Statement, Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas on steps to usher the U.S. into a new era of smarter food safety, Apr. 30, 2019, https://www.fda.gov/news-events/press-announcements/statement-acting-fda-commissioner-ned-sharpless-md-and-deputy-commissioner-frank-yiannas-steps-usher.

47 GCN, The new building block(chain) of health care records management, Mar. 21, 2017, https://gcn.com/articles/2017/03/21/blockchain-health-care.aspx.

48 Section 301(t) of the FD&C Act (21 U.S.C. § 331(t)).

49 The Drug Enforcement Administration (DEA) has also taken an interest in prosecuting companies and individuals for non-compliance with DEA requirements for controlled substances, including, but not limited to, those related to the reporting of suspicious orders as well as the diversion or excessive loss or disappearance of controlled substances. See United States of America v. Rochester Drug Co-Operative Inc., Case 1:19-cv-03568 (S.D.N.Y. 2019); United States of America v. Laurence F. Doud III, Case 1:19-cr-00285-GBD (S.D.N.Y. 2019). See also 21 C.F.R. § 1310.05.

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