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NC MPJE Questions and Answers with Certified Solutions

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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 fi...

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  • September 3, 2023
  • 61
  • 2023/2024
  • Exam (elaborations)
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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

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