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 documenthere.
Besides, the FDA published Questions and Answers on this Guidance for Industry which can be foundhere.
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)