NC MPJE Questions and Answers with
Certified Solutions
DEA Form 222 ✔✔Required for purchase of CI and CII drugs
1 item per line, number of lines noted at the bottom
List name and address of 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 ✔✔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 ✔✔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 ✔✔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 ✔✔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 ✔✔Following sulfonilamide tragedy, required companies to
prove safety to the FDA
1951 Durham-Humphrey Amendment ✔✔Distinguished RX from OTC, label must read RX
only
1961 Kefauver Harris ✔✔Required to prove drug safe and effective if introduced after 1962
Labels on commercial containers ✔✔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 ✔✔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 ✔✔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
Certified Solutions
DEA Form 222 ✔✔Required for purchase of CI and CII drugs
1 item per line, number of lines noted at the bottom
List name and address of 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 ✔✔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 ✔✔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 ✔✔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 ✔✔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 ✔✔Following sulfonilamide tragedy, required companies to
prove safety to the FDA
1951 Durham-Humphrey Amendment ✔✔Distinguished RX from OTC, label must read RX
only
1961 Kefauver Harris ✔✔Required to prove drug safe and effective if introduced after 1962
Labels on commercial containers ✔✔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 ✔✔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 ✔✔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
