No. In May 2005, a Notice of Availability of the draft revision of FDA’s Compliance Policy Guide Section 480.200 (CPG 7132b.11), “Expiration Dating of Unit-Dose Repackaged Drugs,” was announced in the Federal Register. The draft CPG specifies certain conditions when it may be possible to assign up to twelve month expiration-dating to non-sterile solid and liquid oral drug products repackaged into unit-dose containers without conducting new stability studies to support the length of expiration-dating on the repackaged products. The draft CPG was prompted by United States Pharmacopeia (USP) standards for assigning up to a twelve month “beyond-use date” to non-sterile solid and liquid oral dosage forms dispensed in unit-dose containers. (“Beyond-use date” is USP’s pharmacy dispensing term for specifying a date on a prescription container beyond which a patient should not use the product.) If finalized, FDA’s draft CPG would replace the current version of CPG Section 480.200. The current version of CPG Section 480.200 was finalized in March 1995 and provides conditions under which FDA will not initiate action for assigning up to six month expiration dating for drug products repackaged into unit-dose containers without conducting new stability studies. FDA is conducting a stability study of certain commercially repackaged drugs to determine the suitability of the draft revision of CPG Section 480.200. Until the stability study is complete and FDA evaluates all comments submitted to the public docket in response to the May 2005 Federal Register Notice of Availability, the agency does not intend to make a final decision on the draft revision of CPG Section 480.200. Consequently, at this time and until FDA announces a final decision on the draft CPG, the current CPG Section.480.200, which was finalized in March 1995, is in effect.