DEA Form 222 - correct answer Required for purchase of CI and CII drugs
1 item per line, number of lines noted at the bottom
List name and address of
... [Show More] supplier
Copies 1 and 2 are submitted to supplier, copy 3 kept for record
Should record each item received and date received on copy 3
Orders may be partially filled as long as the balance is shipped within 60 days
Supplier may substitute 5x100 when 1x500 is requested
After order is filled, supplier sends copy 2 to Special Agent in Charge at the DEA
Form must be complete and legible, show no signs of alteration or erasure
Order forms must be maintained for 2 years
Software to order CII's electronically is available
Must report stolen or lost forms to the DEA immediately
Must use 222 form to sell to doctor's office for office use
Initial and Biennial Inventory - correct answer Within 10 days of becoming pharmacist-manager
Any time a drug is reclassified from non-controlled to a controlled substance
CIIs must be an exact count or weight
CIII, IV, and V can be estimated unless the bottle contains more than 1000 tabs or caps
Keep record for 2 years, 3 years in NC
Inventory must include:
Name, address, and DEA number of registrant
Date and time inventory was taken
Signature of person doing inventory
Name, dosage form, strength of CS
Number of units or total volume
Emergency Refills - correct answer May give up to a 30 day supply of any drug except a CII, must notify provider within 72 hours
Medication must be essential to the maintenance of life or to the continuation of therapy in a chronic condition
If the physician is unable to provide services to the patient (dies, moves, unable to practice) the pharmacist may dispense a one-time emergency refill of up to a 90-day supply
Order CII, CIII, and CIV for office use - correct answer Schedule II: must use a DEA Form 222 and send to the supplier
CIII and CIV may use an invoice
Identification for CS pick-up - correct answer Required for all CII and some CIII
Acceptable forms: driver's license, special ID issued by NC DMV, military ID, passport
Other pharmacy staff may review the ID
1938 Food, Drug, and Cosmetic Act - correct answer Following sulfonilamide tragedy, required companies to prove safety to the FDA
1951 Durham-Humphrey Amendment - correct answer Distinguished RX from OTC, label must read RX only
1961 Kefauver Harris - correct answer Required to prove drug safe and effective if introduced after 1962
Labels on commercial containers - correct answer Name and address of manufacturer
Ingredient information
Identity (brand and generic name)
Quantity
Net quantity of package (# of pills)
Dosage statement or package insert
Lot number
NDC
Prescription Drug Marketing Act of 1987 - correct answer 1. Reimportation of drugs in US banned
2. Prohibits sale (except emergency) of RX drugs by hospital to non-hospital
3. Prohibits sale of human drugs bought by charitable institutions at reduced prices
4. Bans sale of samples
5. Requires prescribers to request samples in writing
6. Mandates storage and records of samples
DEA Form 41 - correct answer Destruction of controlled substances
Must list all drugs to be destroyed
Must submit a letter requesting permission to destroy the drugs stating proposed date of destruction, method of destruction, and name of 2 witnesses
Witnesses may be physicians, pharmacist, mid-level practitioner, nurse, or law enforcement officer
Must submit 2 signed copies of DEA form 41 to be forwarded to DEA
2 methods of destruction: incinerator or flush into city sewer system
Must keep perpetual inventory of all substances waiting destruction
Hospital: continuous destruction, retail: once a year
If pharmacy transfers CII to a distributor for destruction, distributor must issue a DEA form 222 to the pharmacy, CIII-CV may be documented in writing
Storage of controlled substances - correct answer Must be stored in securely locked cabinet OR dispersed throughout the store
DEA is okay with locking up CIIs and dispersing the rest [Show Less]