Federal MPJE 2024 Verified Solutions

Federal MPJE 2024 Verified Solutions DEA form for narcotic treatment program? ️️363 DEA form for ordering CI/II? ️️-222 -Purchaser sends copy of form to DEA and keeps a copy DEA for for registering a new pharmacy? ️️224 DEA form for reporting loss? ️️-106 -DEA and local authorities should also immediately be called/faxed/messaged regarding the situation DEA for for drug destruction? ️️41 Requirements for a controlled substance prescription: ️️-Dated and signed on issue date -Patient's name/address -Prescriber's name/address/DEA/phone/signature -Drug name/strength/form/quantity/directions/refills -Be issued for legitimate purpose by a professional w/in usual court of practice -Cannot be issued for an individual practitioner for general dispensing to patients Who is responsible for the federal Controlled Substances Act (CSA)? ️️-DEA Which color book is for bioequivalants? ️️Orange Which color book is for biosimilars? ️️Purple Which color book is for drug pricing? ️️Red Which color book is for animal drugs? ️️Green Who keeps the original copy of a DEA form 222? ️️Supplier Non-prescription control purchasing requirements: ️️-Must be 18yo -Only dispensed by pharmacist -Not more than 240cc (8 oz) OR 48 dosage units for opium in a 48-hour period -Not more than 120cc (4oz) OR 24 dosage units for all others in a 48-hour period -Show suitable identification -Record book is maintained w/ name/address of purchaser, name/quantity of product, and name/initials of pharmaicst Considerations for 90-day supplies of C-II: ️️-Issued for legitimate medical purpose -Each script must be fully filled out appropriately -Practitioner may indicate earliest date on which pharmacy can fill each prescription (not requirement) -Each prescription must be dated on the day written What act regulates the sale and recordkeeping requirements for drug samples? ️️Prescription Drug Marketing Act Requirements for the Combat Methamphetamine Epidemic Act: ️️-Placed behind the counter -ID of purchaser verfiied -Log purchaser's name/address/signature -Log product/quantity sold and date/time -Logbook kept for 2 years -Employee training -3.6g per day max OR 9g per 30 days max -No more than 7.5g imported by mail -Logbook not required for sales less than 60mg Quantity limit per day of pseudoephedrine? ️️3.6g Quantity limit per 30 days of pseudoephedrine? ️️9g What amount of pseudoephedrine is the logbook not required to use? ️️Less than 60mg Types of FDA approaches to expedite drug approval: ️️-Fast track -Breakthrough therapy -Accelerated approval -Priority review What is fast track approval? ️️Expedited process for drugs that treat serious conditions and fill an unmet medical need What is breakthrough therapy? ️️Expediated process for drugs that demonstrate substantial improvement over available therapy What is accelerated approval? ️️-Expediated process for drugs with long-term endpoints that are hard to measure -Use surrogate endpoints What is priority review? ️️FDA is to take action on the approval application w/in 6 months What make a drug "adultered?" ️️-Contains decomposed substances -Stored in unsanitary conditions -Not manufactured to required standards -Drug container leaches into the drug -Drug not pure/contains nonlisted active ingredients -Drug contains unapproved color additive What was the first law requiring drugs to be proven safe before being marketed? ️️Food, Drug, and Cosmetic Act What does GMP stand for and what does it do? ️️-Good manufacturi