When the FDA introduced SPL (structured product labeling), the idea was to help inform consumers and improve patient safety. This regulation requires manufacturers to submit prescribing and product information (i.e., the package insert or label) using standardized medical terminology in a readable, accessible format. (more…)
Archive for 2010
Nov 24th
Are you compliant with FDA labeling legislations?
One of the top areas where organizations fall short when audited for FDA compliance is not documenting their standard operating procedures for labeling.
What are you doing to make sure you have the required documentation? (more…)
Nov 23rd
What is HDMA?
The Healthcare Distribution Management Association (HDMA) is the USA’s association representing primary healthcare distributors, the vital link in the healthcare system. Each business day, HDMA member companies ensure that more than nine million prescription medicines and healthcare products are delivered safely and efficiently to 164,000 pharmacies, hospitals, nursing homes, clinics and others nationwide. HDMA and its members work daily to provide value and contain costs, saving the USA’s healthcare system an estimated $32 billion per year. (more…)
Nov 2nd
Product Recalls in Prescription Pharmacy Manufacturing
Do you know labeling errors are the most common reason for product recalls in mainstream pharmacy manufacturing?
There are three key components that need to be in place for prescription pharmacy manufacturers to financially succeed and sustain brand confidence with key stakeholders – and avoid labeling errors.
(more…)
Oct 5th
Reinterpretation of CLP Article 61 – extension to relabelling deadlines
There has been an important development with respect to the 2 year extension to the relabeling deadline This information came into the CHCS via the HSE in the last 2 weeks. (more…)
