NEBRASKA MPJE EXAMINATION SET QUESTIONS AND
ANSWERS RATED A+
✔✔Requirements for Wholesale Drug Distributor License - ✔✔1. A separate license
MUST be obtained for EACH
facility engaged in wholesale drug distribution.
2. Fill out an application
3. PASS an inspection within 6 MONTHS of application
OR if accreditation status by a nationally recognized
accreditation program or another state or federal
regulatory agency inspection approved by the BOP
remains current.
✔✔Criminal Background Checks - Wholesalers - ✔✔Individuals subject to background
check.
1. designated representative of a wholesale drug
distributor.
2. supervisor of the designated representative of a
wholesale drug distributor.
3. Each owner with greater than a 10% interest in the
wholesale drug distributor, it the wholesale drug
distributor in a non-publically held company.
✔✔Inspection requirement - Wholesalers - ✔✔Inspected by DEPARTMENT:
- schedule inspection and pay dept fee including,
but not limited to transportation, lodging, and
meals
- DEPT will inspect within 90 DAYS of request
- MUST conduct during NORMAL business hours
Inspected by NATIONALLY ACCREDITED PROGRAM:
- submit documentation of current accreditation,or
- contact program to schedule inspection + Pay fee
Inspected by ANOTHER STATE or FEDERAL agency
- submit documentation of current state or federal
inspection.
- contact state or federal agency for appointment
and pay fee.
✔✔Inspection requirements - Wholesalers - ✔✔Every 3 Years
✔✔Standards for Engaging in Wholesale Drug Distribution -- Personnel - ✔✔1. have
knowledge of federal and state statutes
2. No felony/convictions related to controlled drugs
3. MINIMUM of TWO (2) years of full time managerial or
supervisory experience in a pharmacy or wholesale
drug distributor licensed in any state, with
, responsibilities including record keeping, storage,
and shipment of Rx's.
4. Be actively involved in and aware of the actual daily
operations of the wholesale drug distributor. (BE ON
SITE)
✔✔Standards for Engaging in Wholesale Drug Distribution --Facility - ✔✔1. Suitable for
accurate storage of all Rx medications
2. Be big enough for daily operations
3. Have adequate storage areas
4. Have area for drugs that are unfit for distribution
5. Be clean and orderly
6. Be free from infestation of any kind
7. Commercial location (NOT private residence)
8. Provide secure storage of policies and procedures
9. Maintain inventory control to detect theft, etc.
10. Provide adequate drug pedigrees for drugs that
leave normal distribution chains
11. Maintain PEDIGREES for THREE (3) YEARS
12. Duly registered with DEA and state controlled
substance agency and in compliance with
controlled substance laws
✔✔Drug Pedigrees - ✔✔kept for 3 YEARS
Mfgs and Wholesalers have to provide adequate authentication of pedigree information
in 48 HOURS
> 48 HOURS, must quarantine drug and file to DEPT within 5 BUSINESS DAYS
✔✔Standards for Engaging in Wholesale Drug Distribution -- Pedigrees - ✔✔ALL
DRUGS THAT LEAVE THE NORMAL DISTRIBUTION CHAING MUST BE
ACCOMPANIED BY A PAPER OR ELECTRONIC PEDIGREE
✔✔Pedigrees - ✔✔MUST INCLUDE:
1. Name of Drug
2. Dosage Strength and Form
3. Container size
4. Number of containers
5. Lot number
6. Name of original manufacturer
7. Name, Address, Telephone #, and (if applicable)
email of each owner of the drug and each wholesale
distributor who does not take title to the drug.
8. Name and Address of each location from which the
drug was shipped if different from owner
9. Transaction dates
10. Certification that each recipient has authenticated
ANSWERS RATED A+
✔✔Requirements for Wholesale Drug Distributor License - ✔✔1. A separate license
MUST be obtained for EACH
facility engaged in wholesale drug distribution.
2. Fill out an application
3. PASS an inspection within 6 MONTHS of application
OR if accreditation status by a nationally recognized
accreditation program or another state or federal
regulatory agency inspection approved by the BOP
remains current.
✔✔Criminal Background Checks - Wholesalers - ✔✔Individuals subject to background
check.
1. designated representative of a wholesale drug
distributor.
2. supervisor of the designated representative of a
wholesale drug distributor.
3. Each owner with greater than a 10% interest in the
wholesale drug distributor, it the wholesale drug
distributor in a non-publically held company.
✔✔Inspection requirement - Wholesalers - ✔✔Inspected by DEPARTMENT:
- schedule inspection and pay dept fee including,
but not limited to transportation, lodging, and
meals
- DEPT will inspect within 90 DAYS of request
- MUST conduct during NORMAL business hours
Inspected by NATIONALLY ACCREDITED PROGRAM:
- submit documentation of current accreditation,or
- contact program to schedule inspection + Pay fee
Inspected by ANOTHER STATE or FEDERAL agency
- submit documentation of current state or federal
inspection.
- contact state or federal agency for appointment
and pay fee.
✔✔Inspection requirements - Wholesalers - ✔✔Every 3 Years
✔✔Standards for Engaging in Wholesale Drug Distribution -- Personnel - ✔✔1. have
knowledge of federal and state statutes
2. No felony/convictions related to controlled drugs
3. MINIMUM of TWO (2) years of full time managerial or
supervisory experience in a pharmacy or wholesale
drug distributor licensed in any state, with
, responsibilities including record keeping, storage,
and shipment of Rx's.
4. Be actively involved in and aware of the actual daily
operations of the wholesale drug distributor. (BE ON
SITE)
✔✔Standards for Engaging in Wholesale Drug Distribution --Facility - ✔✔1. Suitable for
accurate storage of all Rx medications
2. Be big enough for daily operations
3. Have adequate storage areas
4. Have area for drugs that are unfit for distribution
5. Be clean and orderly
6. Be free from infestation of any kind
7. Commercial location (NOT private residence)
8. Provide secure storage of policies and procedures
9. Maintain inventory control to detect theft, etc.
10. Provide adequate drug pedigrees for drugs that
leave normal distribution chains
11. Maintain PEDIGREES for THREE (3) YEARS
12. Duly registered with DEA and state controlled
substance agency and in compliance with
controlled substance laws
✔✔Drug Pedigrees - ✔✔kept for 3 YEARS
Mfgs and Wholesalers have to provide adequate authentication of pedigree information
in 48 HOURS
> 48 HOURS, must quarantine drug and file to DEPT within 5 BUSINESS DAYS
✔✔Standards for Engaging in Wholesale Drug Distribution -- Pedigrees - ✔✔ALL
DRUGS THAT LEAVE THE NORMAL DISTRIBUTION CHAING MUST BE
ACCOMPANIED BY A PAPER OR ELECTRONIC PEDIGREE
✔✔Pedigrees - ✔✔MUST INCLUDE:
1. Name of Drug
2. Dosage Strength and Form
3. Container size
4. Number of containers
5. Lot number
6. Name of original manufacturer
7. Name, Address, Telephone #, and (if applicable)
email of each owner of the drug and each wholesale
distributor who does not take title to the drug.
8. Name and Address of each location from which the
drug was shipped if different from owner
9. Transaction dates
10. Certification that each recipient has authenticated
