J. Randall Hoggle, B.Pharm., D.Ph., M.B.A., is the managing director of Advasur, LLC
J. Randall Hoggle, B.Pharm., D.Ph., M.B.A., Managing Director, Advasur, LLC

I WOULD BE REMISS NOT TO RECOGNIZE THE WEIGHTED responsibility you have as a pharmacist, that until the DSCSA compliance federal mandate, you did not shoulder, but do now. This is the first of a series of articles on DSCSA.

What Is DSCSA?

The Drug Quality and Security Act (DQSA) contains two titles: Title I, which relates to compounding pharmacy practice, and Title II, the Drug Supply Chain Security Act (DSCSA), which relates to the noncompounded prescription products that make up most of your practice. DQSA and its Title II, DSCSA, were enacted into law to reduce the counterfeit drug rate in the United States, estimated still to be greater than 2%.

What Do Pharmacists Have to Do Today? 5 Requirements To Know And The Most Common Inspection Pitfalls

The DSCSA compliance has 10 requirements, as Advasur categorizes them in the absence of the FDA’s Center for Drug Evaluation and Research (CDER) requirement categorization. These are the five current requirements pharmacists have been responsible to comply with since March 2016.

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Requirement #1: Authenticate and Validate Authorized Trading Partners (ATPs)

• Dispensers must validate and authenticate every supplier who provides Rx products to your pharmacy. Your suppliers will also be validating your state pharmacy license and DEA (Drug Enforcement Administration) license.

• This is not just the dispensers’ wholesalers but every supplier, including generic manufacturers you buy from routinely or occasionally.

DSCSA Track and Trace Compliance Timeline Drug Supply Chain Security Act Inspections
Source: www.pharmaceuticalcommerce.com/view/2016-product-security-report

Requirement #2: Receipt and Validation of Rx Product Electronic Advance Shipping Notices

• The dispenser must track and validate every Rx product you receive by validating and retaining the advance shipping notice (ASN) sent to you for every shipment of Rx, which many times is a mixed shipment of Rx and non-Rx products.

• The dispenser, upon a federal and/or state government authority request, must produce an ASN for any product that the dispenser (since March 2016) should have collected and held in an electronic file, usually a repository, within 48 hours of the authority’s request.

Requirement #3: Quarantine Suspected Illegitimate Drugs

It is important that you set up suspicious order fulfillment standard operating procedures (SOPs) and then your quarantine SOPs for suspected illegitimate drug investigations. This is the only request a federal or state government inspector can make that the pharmacist does not have 48 hours to respond to. For requirement #3, the pharmacist on duty (POD) has to produce this SOP and deliver it upon request. It is important to develop “comprehensive” DSCSA compliance SOPs, not just SOPs to quarantine suspect illegitimate drugs, and your SOPs should be hyperlinked to the federal and state government guidance updates, so they never become outdated.

Requirement #4: Notification of FDA and Trading Partners of Suspect Illegitimate Drugs

Upon identifying a suspect product and then validating that it is illegitimate, your pharmacist in charge (PIC) must notify that supplier and, using a Form 3911, must notify the FDA simultaneously.

Requirement #5: Provide a Timely Response to Government Authorities and Trading Partners

This requirement is by far the most critical requirement to be able to demonstrate 100% compliance. Upon a federal or state government authority’s entrance into your pharmacy and demand for product shipping information or any other requirements #1 through #4 information, you must be able to produce this within 48 hours. No exceptions and no excuses.

These Are the Most Common Pitfalls for Pharmacists When Inspected:

(a) Assumption that the wholesaler has you covered: a. The wholesaler supplier is one supplier and does not have any of your other suppliers’ data. b. Wholesaler, secondary wholesalers, and direct- selling generic suppliers should provide the 10 data ASNs, but portal access to an electronic packing slip or transaction history summary does not have all 10 data sets required on the ASN documentation.

(b) Belief that they don’t need to worry about federal DSCSA compliance until they hear about inspections occurring:

The FDA on Feb. 2, 2022, announced effective Feb. 7, 2022, that they were renewing their supply chain compliance inspections based on the COVID-19 pandemic subsiding.

Additionally, in the FDA announcement referenced above, the FDA will look to add nonphysical inspection tools like remote assessment auditing and monitoring systems. We anticipate that these remote tools will include a tabletop electronic audit with the request of up to six years of data, as allowed under the law.

(c) Belief that they don’t need to worry about state DSCSA compliance inspections: The state boards of pharmacy have been more active inspection authorities than the federal authorities. Also, if the state boards of pharmacy use the remote assessment auditing and monitoring systems announced to be used on the federal level, then the number of pharmacies being inspected at a state level and the frequency of inspection could be greatly increased. CT

J. Randall Hoggle, B.Pharm., D.Ph., M.B.A., is the managing director of Advasur, LLC, the Advasur Audit & Supply Chain Resource Center in Rockville, Md. The author can be reached at r.hoggle@advasur.com.

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