Supply Chain Logistics

Your supply chain may not be as ironclad as you think.

If you manufacture, distribute — or even reverse distribute — controlled substances, you shouldn’t underestimate your risk for drug diversion and abuse. The journey of the pill can be a long and winding one, with unsavory characters waiting in the shadows to do bad things with good shipments.

Today’s DEA rules and regulations are so complex, business owners and practitioners struggle to understand what they should be doing. Plus, the opioid crisis has resulted in more federal and state resources being put toward preventing drug diversion. And, the pressure is on investigators to step up controlled-substance compliance programs and conduct even tougher oversight.

96% of online pharmacies
do not comply
with applicable
laws and standards put in place
to protect patients

Source: Alliance for Safe Online Pharmacies. Key data about online
sales of prescription medicines. Last updated February 2016.

The World Health Organization
estimates that the counterfeit
and grey markets were worth
$75 billion dollars in 2010.

Source: Growing threat from counterfeit medicines. Bull World Health Organ.
2010 Apr; 88(4): 247-8. [PubMed]

Manufacturers, repackagers,
wholesalers and dispensers must
provide transaction information,
transaction history, and a transaction
statement to each subsequent
owner of the drug product.

Source: www.ncbi.nlm.nih.gov/pmc/articles/PMC4911992

Hefty civil fines are being levied against non-compliant individuals and businesses across the healthcare industry, including supply chain and logistics operations. Inspections conducted by the DEA and state agencies are typically unannounced, and the current federal fine per infraction is $14,502. But, it’s not uncommon for fines to exceed $1 million.

Most common violations
cited by the DEA:

Registration
issues

Most common violations
cited by the DEA:

Lack of
physical security

Most common violations
cited by the DEA:

Poor
record-keeping

Most common violations
cited by the DEA:

Failure to
prevent diversion

It can happen to you.

If you’re handling controlled substances in any way, you’re at risk for drug diversion. It’s imperative that you be prepared. Now is the time to investigate, identify, correct and strengthen your operation against the most common vulnerabilities you face today. Keeping up with changing standards, best practices, new requirements and growing threats are the most effective ways to protect your company. But failing to adapt to these new realities may not only cost you financially, it can also cause irreparable harm to your personal and professional reputation.

Don’t worry. We can help.

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