Logistics and 3PL requirements for medical devices

[SGquality]

I have read lot of Wholesale Distributor and Third-Party Logistics (3PL) provider requirements for Drugs under the Drug Supply Chain Security Act (DSCSA) applicable for CDER and CBER. Are there any specific regulatory requirements specifically for the medical device industry besides requirements that they have a QMS (Quality Management System), perform internal audits, have a process for CAPAs (Corrective and Preventative Action), process to handle recalls, handle inventory, traceability etc.?

Thank you!

 

[chris1price]

Unlike for drugs, there are no specific regulatory requirements for medical device wholesalers or 3PL warehouses. However, there is a general requirement that they should ensure the device is unharmed in any way (temperature, humidity, physical damage, etc). It is up to the manufacturer to specify what level conformity or certification the QMS should have. Any additional requirements should be in a quality agreement. Today a ISO9001 compliant QMS would probably be the minimum.

Under the new EU MDR there are requirements for importers and distributors. the 3PL warehouses may get involved here.

 

[SGquality]

.... Under the new EU MDR there are requirements for importers and distributors. the 3PL warehouses may get involved here.

Could you please direct me to the EU MDR requirements?

 

[chris1price]

Download a copy of the EU MDR, 2017/745 and take a look at Articles 13 and 14.

 

[SGquality]

Thanks for the reference. However that is applicable for the distributors and not the third-party logistics service provider. In my scenario, these 3PL would be an entity that provides or coordinates logistics services of a product in interstate commerce on behalf of a manufacturer or a wholesale distributor, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.

 

[meddevuser]

The National Associations of Boards of Pharmacy have established an accreditation process for wholesale distributors (VAWD) (see nabp.pharmacy/programs/vawd/) The criteria for accreditation includes a lot of the Drug Supply Chain Security Act (DSCSA) requirements and it applies to both prescription drugs and devices. Please be aware that individual states also have regulatory requirements--if you ship prescription products (drugs or devices) into a state, you need to (in most cases) be specifically licensed to do so by that state and may have other regulatory reporting requirements at the state level to maintain your license. You can review the criteria on line without making any commitment to pursue VAWD.

 

[meddevuser]

With regards to 3PL, you will still need to follow the requirements of the DSCSA at all points of logistics and distribution. Again, the DSCSA has specific sections that apply to both drugs and devices beyond the one's listed in the original post--how about suspect product? Illegitimate product? Diversion of product? Reporting requirements? Work with the client you are servicing to set the boundaries of what is and what isn't in your scope for regulatory requirements. You may be surprised what they consider to be on your side of the fence.

 

[medicaldevicequestions]

@meddevuser @chris1price @SGquality

Did you ever come to consensus on this topic?

My understanding is that the DSCSA does not address 3Pls who manage medical devices, just 3PLs who manage drugs/prescription drugs/etc.

However, the State Board of Pharmacy of many states suggest that all 3PLs need a license even though in their state code they specifically mention drugs and not devices...or if they mention devices they clarify devices as "devices used in the delivery of a drug" (e.g., insulin pump).

Thoughts? I know that there was a Medical Device Distribution Licensing Act of 2015 (part of the 21st Century Cures Act" that never passed that would have addressed this.

 

[meddevuser]

Last October the State of Alaska started requiring non resident wholesale licenses. The regulation itself only mentions Rx drugs but the State published a faq in December that had a user ask specifically about Rx medical devices—guess what, you need the same license to distribute Rx medical devices into Alaska. Say what? Yep. Vermont recently broke their non resident manufacturer license into 3 sub specialties including contract manufacturing—that’s a first for me!

Licensing is the single most convoluted, complex, contradictory compilation of compliance codes ever passed into State or Federal law. There are several states that absolutely require licenses or permits for medical devices. You have to read definitions, determine what licenses are offered, read the application requirements, and doublecheck everything. There are states that require specific licenses for OTC drug distribution.

My employer only makes drug products that are exempt from DSCSA (IV solutions, combo kits containing anesthetic) as well as Rx med devices and OTC drugs (surgical soaps). Combination kits we make are FDA registered medical devices even though they contain drug product like Lidocaine. Exempt yeah— from transaction documentation (pedigree) requirements that’s it—The IV fluid is still a drug as is the anesthetic drug. Companies that purchase from us still have to verify that we hold the proper licenses to sell and distribute to them and we have to verify that these products are purchased by and shipped to licensed facilities by our warehouse that can ship to the customers state.

I started in supply chain in 2013 working for a 3pl contracted for domestic and OUS distribution by a global med tech company. In 2019, the contract ended by the customer taking on their own distribution—all of us were transitioned into the customers company. I’ve been the designated rep for the distribution site since 2013–we still maintain some 3PL licenses due to company structure of some subsidiaries. Anyhow, with all that said, if you are looking for consensus I doubt you will find it. Every company has a different risk profile, different products, different distribution strategy, etc. DSCSA does not include Rx medical devices... but some of the requirements in DSCSA are applied to Rx med devices by state regulations directly or indirectly IMHO.

 

[LUFAN]

This is a bit of an older thread, but reading through the comments on the proposed rule, there are a lot of comments of medical device companies and industry professionals. A few of which seem confused, or using their interpretation whether or not DSCSA will apply to them. One comment I read "Some states interrupted the DSCSA rule to include prescription legend medical devices. Does this proposed rule clear up this misinterpretation? Prescription medical devices (Class II) is still regulated as per CDRH rules, correct? "

The state interpretation could add a lot of confusion/burden on a manufacturer if they assumed DSCSA did apply to a medical device only 3PL. I'm hoping FDA attempt to make clear the regulation come final rule time. Having read the proposed rule and sitting on it for a while, I still find it a bit odd FDA didn't want to include medical devices in the rule.