Requested clarification for the billing unit quantity. At the February 2011 WG2 meeting the form was discussed. Issue: Product label has 2 different package size listings.
--Net contents after reconstitution: 175ml
--Deliverable volume after reconstitution: 160-165ml
(There is also a 225ml listing but it reads like that is the size of the bottle, not the volume contained, “contains 225ml bottle with bottle adapter…”)
Which volume after reconstitution is used when the deliverable volume is variable (a range from 160 – 165ml)?
Discussion: The Product Review and Billing Unit Exception Task Group discussed on their calls of October 26, December 7, January 4, and January 18:
Background: The dilemma associated with CellCept Oral Suspension is that its deliverable volume after constitution is stated as a range (160-165mL). If CellCept Oral Suspension remains as 175mL on the databases, then it will be an exception to the BUS. Therefore, should we change existing FAQs to include CellCept Oral Suspension, or add a new FAQ?
Concern: Are we consistent in the BUS in how we are addressing reconstitutable products? It appears we are clear on powders for injection. The non-injectable, reconstitutable products when the final volume is not expressed or the reconstituted volume is not fully delivered seem to be the most problematic.
The group reviewed the package image of the product and looked to the BUS for possible modifications.
Decision: Change Section 5.2.3 and FAQ 7.34 of the BUS as follows (changes in red).
5.2.3
Reconstitutable Non-injectable Products must be billed as the total number of milliliters (ML) dispensed after reconstitution; i.e., once the powder and added flavor packet (if applicable) have been reconstituted with diluent, according to manufacturer instructions. For example, Amoxicillin Suspension 25Ø mg/15Ø ml is billed as 15Ø ml and GolytelyÔ 4ØØØ ml bottle is billed as 4ØØØ
ml. See section “Frequently Asked Questions”, question 7.34.
For non-injectable products to be reconstituted, the package size will be based on the total amount of the product delivered (maximum amount that can be extracted from the container; i.e. dispensed). The overfill after reconstitution will not be considered. Example: Tamiflu for Oral Solution contains approximately 33 mL, after reconstitution. Each bottle can delivers up to a total of 25mL of solution.suspension. The reported quantity for dispensing should be 25mL.
For non-injectable products to be reconstituted where the deliverable volume is expressed as a range, the reported quantity for dispensing will be the lower volume of the range. Example: CellCept 200mg/mL oral suspension lists the net content after reconstitution as 175 mL and the deliverable volume after constitution as 160-165 mL. The reported quantity for dispensing should be 160mL.
Should the WG approve, the compendia will make their database changes from 175 ml to 160 ml at the end of the first quarter. Changes to the BUS will be incorporated into the DERF submitted for the May 2011 WG meeting.
When there is a range given, the least amount should be billed. The compendia have 175 mL currently. A motion was moved and seconded to approve as suggested by the task group. The motion carried without opposition. The three examples are Valcyte, Cellcept and Tamiflu. These should be sent to the FDA to shows160 mL as the volume in the SPL.