New FDA Guidance on Dosage Delivery Devices (measuring Spoons, Droppers, etc.)
In May 2011 the FDA published the Guidance for Industry "Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products".
Many liquid drug products which must be orally ingested are packaged with dosage delivery devices intended to facilitate proper dispensing of the product by the patient. These devices have calibrated units of measure (e.g. millilitres) and should ensure proper measurement of the appropriate dose.
For around 20 years now (since 1991), the FDA has been criticizing the fact that many orally ingested OTC products (= over-the-counter, e.g. non-prescription products) available on the market are packaged with insufficient dosage delivery devices which don't meet with the requirements.
The FDA possesses numerous reports about accidental overdose that were partially due to wrong dosage delivery devices. The FDA is particularly concerned because many orally ingested OTC liquid drug products are designed for children. The topic raises FDA's concerns regarding drug safety.
In the new Guidance, the FDA considers any written, printed, or graphic matter, including measurements on dosage delivery devices, packaged with OTC liquid drug products to be "labeling" according to FD&C Act. Wrong indications render the drug product "misbranded".
A large number of recommendations are made to find a way to improve the situation in the future. Firms should also perform "Usability Studies". The Guidance presents further examples of misbranded dosage delivery devices and in Appendix B you can find an example of how labeling should be.
You can find the full document
here.Besides, the FDA published Questions and Answers on this Guidance for Industry which can be found
here.Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Related GMP News
24.07.2024FDA Warning Letter to Chinese OTC Manufacturer for Lack of Analytical Test Data
10.07.2024Pharmeuropa: Two Revised Chapters on Dissolution Testing published for comments
03.07.2024FDA Warning Letter: GMP Requirements also apply to HPLC Analyses for Internal Use
12.06.2024NMPA Announcement on Application of ICH Q2(R2) and Q14 Principles
22.05.2024Q&As from the Live Online Training "Introduction to the AQCG's new AIQSV Guide" - Part 1
22.05.2024FDA Warning Letter to Contract Testing Laboratory in Uruguay due to Data Integrity Violations