Product Labeling means, with respect to a particular pharmaceutical product and a particular country, (a) the full prescribing information for the product approved by the applicable Regulatory Authorities in such country, including any required patient information; and (b) all labels and other written, printed or graphic matter physically upon a container, wrapper or any package insert utilized with or for the product in such country.
Ignition cycle download means the number (count) of power mode cycles as determined by the EDR ECU at the time when the data was downloaded since the first use of the EDR.
Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate):
Drug outlet means a pharmacy, nursing home, shelter home, convalescent home, extended care facility, drug abuse treatment center, penal institution, hospital, family planning clinic, student health center, retail store, wholesaler, manufacturer, mail-order vendor or other establishment with facilities located within or out of this state that is engaged in dispensing, delivery or distribution of drugs within this state.
PSP or “PSPs” means the State’s IT Policies, Standards and Procedures. “SSAE” means Statement on Standards for Attestation Engagements.