Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Is there any guidance from FDA prohibiting post-consumer resin in primary packaging or suggesting it is inappropriate? The only information I've been able to find is in a 1999 guidance document on containers and closures that predated innovations in the PCR manufacturing space.  FDA now grants Letters of No Objection for use of PCR in food, wondered if there is any updated information for drug packaging.

Anon,

I am not sure about drug packaging, but a few years back there were some mummering on the medical device side about US FDA issuing some position statement on use of post-consumer materials in material packaging, i.e. using recycled materials for packaging.  Think green !  Personally, I am all for this and it would be nice if not just US FDA, but other regulatory agencies were a bit more progressive in current state of the world by providing direction and guidance on use of post-consumer materials (recycled materials).  I saw the notice from FDA as well on food packaging, think maybe around 2019 or 2020, but I am not personally aware of anything related to drug, biologics, or medical devices.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 01-May-2023 07:35
From: Anonymous Member
Subject: Post consumer resin (PCR) in primary packaging for drug

This message was posted by a user wishing to remain anonymous

Is there any guidance from FDA prohibiting post-consumer resin in primary packaging or suggesting it is inappropriate? The only information I've been able to find is in a 1999 guidance document on containers and closures that predated innovations in the PCR manufacturing space.  FDA now grants Letters of No Objection for use of PCR in food, wondered if there is any updated information for drug packaging.

Hi, Anon - My direct experience with this topic is very dated (back in the mid-90's when I worked for a pharma primary packaging material supplier) - so definitely anything I know from then predates the innovations you mention in the PCR manufacturing space. 

However, I found a site that may provide some more information leads for you.  The Institute of Packaging Professionals has a Drug and Pharmaceutical Packaging Committee.  They have a list of Industry Resources on this page (https://www.iopp.org/i4a/pages/index.cfm?pageid=567) along with general information about the committee at their home page.

I hope this helps!

Carolyn Tomlinson ASQ CQE, CSSBB, CMDA, CQA
Sr. Director QMS Consulting and Training
Washington, DC

Original Message:
Sent: 01-May-2023 07:35
From: Anonymous Member
Subject: Post consumer resin (PCR) in primary packaging for drug

This message was posted by a user wishing to remain anonymous

Is there any guidance from FDA prohibiting post-consumer resin in primary packaging or suggesting it is inappropriate? The only information I've been able to find is in a 1999 guidance document on containers and closures that predated innovations in the PCR manufacturing space.  FDA now grants Letters of No Objection for use of PCR in food, wondered if there is any updated information for drug packaging.