Update on the Status of USP <661.1> and <661.2>

May 31, 2018

USP announced last year that the newly issued <661.1> “Plastic Materials of Construction” and <661.2> “Plastic Packaging Systems for Pharmaceutical Use” were being suspended until May of 2020 so that the pharmaceutical industry could adapt to all of the significant changes made to the “old” version of <661>.  In the meantime <661> “Containers Plastic” was back in effect as the chapter of record.  However, FDA may have their own opinion on the “suspension” of <661.1> and <661.2>.  Many pharmaceutical companies submitting NDAs and ANDAs are receiving deficiencies for not having packaging systems tested according to these new chapters.  Furthermore, representatives from the USP Packaging Expert Panel announced last week at the PharmaEd Resources E&L Conference in Philadelphia that the “grandfathering” clause for currently marketed pharmaceutical drugs will be removed in edition to <661.2> that will be released in May 2020.  This means that all packaging systems will have to be tested and meet the specification of <661.1> and <661.2>.  At Pine Lake Laboratories, we recommend that our clients don’t wait until 2020 to be compliant with these new chapters.  We can design a stepwise, integrated approach to ensure that our client’s plastic packaging systems meet the FDA expectations today as well as a few years down the road.