Old Habits Could Be Costly
An update from Compounders StateSide.
It takes a while for most people to break the habit of writing “2014” on correspondence. Most people understand that a letter or payment received with an accidental “2014” know that you really intended it to read “2015.”
The first day of the year isn’t just a change in the date, it also is one of the days most frequently cited in state legislation and regulations for when new laws go into effect. And continuing habits from 2014 into 2015 can lead to unintentional violations of those laws.
In compounding, many new regulations and changes went into effect on January 1, including:
• California – clarified that any 503B outsourcing facility must also register as a pharmacy in the state.
• Maryland – formally delayed its sterile compounding permit requirements from January 1 to July 1, 2015.
• Michigan – new legislation enables the Board to bill non-resident compounding pharmacies for all costs associated with inspections and investigations.
• North Carolina – new rules require compliance with USP <795> and <797> and also requires individual patient specific prescriptions for all compounded preparations.
IACP monitors all state legislation and Board of Pharmacy regulation and rule promulgation each and every week. In 2014, your Academy reviewed and tracked 82 pieces of state legislation affecting compounding pharmacy. Of those, 23 new laws were enacted, 13 are still pending in those states with multi-year legislatures, and 46 were defeated.
You can keep yourself up-to-date by making a new resolution to check our Compounders StateSide section of the IACP website where you can see what new legislation has been introduced, where it is within the hearing process, and what the final outcome is. To see the summary of 2014 legislation, including the pending bills which we continue to monitor, click here.