March 30, 2016: Changes in Expression of Strength: Elimination of Ratios on Single-Entity Injectable Products
The standards set by the United States Pharmacopeial Convention, through the United States Pharmacopeia and the National Formulary (USP-NF), are being updated for publication as USP39-NF34. One of the changes in the new edition will be the elimination of ratios as an acceptable method for expressing the strength of single-entity injectable products. The requirement for compliance with this change will take effect in the United States on May 1, 2016. After that date, the strength on the labels for all such products must be expressed only as the amount per unit volume (e.g., mg/mL). While it is unknown exactly how these changes will affect Canadian products, it is anticipated that manufacturers of affected products will be required to meet these standards. Read more ...
