Federal Law MPJE UPDATED ACTUAL
Exam Questions and CORRECT Answers
Red Book - CORRECT ANSWER - Drug pricing and packaging information
The Orange Book - CORRECT ANSWER - - Official name: "Approved Drug Products
with Therapeutic Equivalence Evaluations"
- Primary source for therapeutic equivalency of drugs
Two-letter coding system:
- Starts with A = FDA considers the drug to be pharmaceutically and therapeutically equivalent
- Starts with B = Not equivalent
- Second letters (e.g. T) = Dosage form (e.g. topical)
Examples:
AA = Conventional dosage forms (equivalent)
AN = Aerosolization solutions/powders (Nasal?)
AO = Injectable Oil solutions
AP = Injectable aqueous solutions (iv Push?)
AT = Topical
AB = Potential bioequivalence problems, but evidence has shown bioequivalence.
The Purple Book - CORRECT ANSWER - Lists biological products that are considered
biosimilars and provides interchangeability evaluations for these products
Pink Book - CORRECT ANSWER - Immunizations, vaccine-preventable diseases, and
vaccine safety
Yellow Book - CORRECT ANSWER - CDC's standard resource on travel information
,Occupational Safety and Health Administration (OSHA) - CORRECT ANSWER -
Requires employers to meet the Hazardous Communication Standard to protect workers:
- Harzardous communication plan (e.g. Safety Data Sheet)
- Trained workers on hazardous chemicals
The Consumer Product Safety Commission - CORRECT ANSWER - Administers the
Poison Prevention Packaging Act (PPPA)
The Drug Enforcement Administration (DEA) - CORRECT ANSWER - Part of the U.S.
Department of Justice and is responsible for the federal Controlled Substances Act (CSA).
Controlled Substance Ordering System (CSOS) - CORRECT ANSWER - Allows for
secure electronic transmission of Schedule I-V controlled substance orders without the
supporting paper Form 222, CANNOT be faxed anymore.
Purchasing Scheduled II CS - CORRECT ANSWER - 1. Pharmacy fills out a DEA Form
222 and submit to the supplier. Supplier receives the original form.
2. The purchaser is required to make a copy of the original DEA Form 222 for records (paper or
electronic).
DEA Form 41 - CORRECT ANSWER - - Documents disposal and destruction of
scheduled drugs. Transferring CS to a reverse distributor requires them to document the
destruction NOT the pharmacy.
- Required on the form:
1) Name
2) NDC number
3) Strength
4) Dosage form
5) Package size
6) Quantity
7) Method of destruction
,8) 2 witness signatures
DEA Form 106 - CORRECT ANSWER - - "Report of Theft or Loss of Controlled
Substances
- The form requests information such as the name and address of the registrant, phone number,
name of the police department contacted, type of theft or loss, purchase value to registrant and
name of common carrier.
- MUST "notify" the DEA within 1 business day, but the form does not need to be submitted
within that time
DEA Form 222 - CORRECT ANSWER - - Order and transfer form for C-I and C-II
substances. Must be kept for 2 years (NORMAL forms for other CS).
- Must be signed by the most recent pharmacist, but could be bestowed to others via power of
attorney
- Executed DEA Form 222 must be maintained separately
- Defective DEA Form 222 must be replaced by using Form 222a to order more forms and
MUST be returned to the DEA with a reason (illegible or altered)
- Triplate forms:
1. Brown copy goes to supplier (warehouse color)
2. Green copy goes to the supplier (then to DEA, the people making money-green)
3. Blue copy is retained by purchaser which they will then fill out upon receipt of packages
power of attorney - CORRECT ANSWER - must be signed by the registrant and the
person to whom the power of attorney is being granted, and two witnesses
DEA Form 224 - CORRECT ANSWER - - registration form for all pharmacies and
facilities that dispense and possess controlled drugs. must be renewed every 3 years and renewal
notification sent 60 days prior to expiration.
- Form 224a for renewals
, DEA Form 225 - CORRECT ANSWER - Registration form for manufacturers,
distributors, researchers, analytical laboratories, importers, exporters
DEA Form 363 - CORRECT ANSWER - New Application Registration - Narcotic
Treatment Program
DEA registration number - CORRECT ANSWER - - First letter indicates practitioner
status (e.g. A/B/F = practitioner, M = Mid-level practitioner)
- Second letter indicates the first letter of the practitioner's last name/pharmacy name/hospital
name
Verifying DEA number - CORRECT ANSWER - 1. Add 1st, 3rd, and 5th digits together
2. Add 2nd, 4th, and 6th digits together. Multiply by 2
3. Add Step 1 and Step 3 together. The last digit of this sum should match the last digit of the
prescriber's DEA number (Check Digit)
Example: BT6835752
1. 6 + 3 + 7 = 16
2. (8 + 5 + 5) * 2 = 36
3. 16 + 36 = 52 = 2
Temporary use of a DEA registration upon sale of a pharmacy - CORRECT ANSWER --
A new owner may continue the business under the previous owners DEA number.
- The new owner must "expeditiously" apply for an appropriate DEA registration.
- The previous owner is still held accountable, and must sign a power of attorney.
- Can only be in effect for 45 days.
Investigational New Drug Application (IND) - CORRECT ANSWER - Submitted and
approved by the FDA before a drug can be tested in humans. The FDA has 30 days to decide if
the drug is suitable.
Exam Questions and CORRECT Answers
Red Book - CORRECT ANSWER - Drug pricing and packaging information
The Orange Book - CORRECT ANSWER - - Official name: "Approved Drug Products
with Therapeutic Equivalence Evaluations"
- Primary source for therapeutic equivalency of drugs
Two-letter coding system:
- Starts with A = FDA considers the drug to be pharmaceutically and therapeutically equivalent
- Starts with B = Not equivalent
- Second letters (e.g. T) = Dosage form (e.g. topical)
Examples:
AA = Conventional dosage forms (equivalent)
AN = Aerosolization solutions/powders (Nasal?)
AO = Injectable Oil solutions
AP = Injectable aqueous solutions (iv Push?)
AT = Topical
AB = Potential bioequivalence problems, but evidence has shown bioequivalence.
The Purple Book - CORRECT ANSWER - Lists biological products that are considered
biosimilars and provides interchangeability evaluations for these products
Pink Book - CORRECT ANSWER - Immunizations, vaccine-preventable diseases, and
vaccine safety
Yellow Book - CORRECT ANSWER - CDC's standard resource on travel information
,Occupational Safety and Health Administration (OSHA) - CORRECT ANSWER -
Requires employers to meet the Hazardous Communication Standard to protect workers:
- Harzardous communication plan (e.g. Safety Data Sheet)
- Trained workers on hazardous chemicals
The Consumer Product Safety Commission - CORRECT ANSWER - Administers the
Poison Prevention Packaging Act (PPPA)
The Drug Enforcement Administration (DEA) - CORRECT ANSWER - Part of the U.S.
Department of Justice and is responsible for the federal Controlled Substances Act (CSA).
Controlled Substance Ordering System (CSOS) - CORRECT ANSWER - Allows for
secure electronic transmission of Schedule I-V controlled substance orders without the
supporting paper Form 222, CANNOT be faxed anymore.
Purchasing Scheduled II CS - CORRECT ANSWER - 1. Pharmacy fills out a DEA Form
222 and submit to the supplier. Supplier receives the original form.
2. The purchaser is required to make a copy of the original DEA Form 222 for records (paper or
electronic).
DEA Form 41 - CORRECT ANSWER - - Documents disposal and destruction of
scheduled drugs. Transferring CS to a reverse distributor requires them to document the
destruction NOT the pharmacy.
- Required on the form:
1) Name
2) NDC number
3) Strength
4) Dosage form
5) Package size
6) Quantity
7) Method of destruction
,8) 2 witness signatures
DEA Form 106 - CORRECT ANSWER - - "Report of Theft or Loss of Controlled
Substances
- The form requests information such as the name and address of the registrant, phone number,
name of the police department contacted, type of theft or loss, purchase value to registrant and
name of common carrier.
- MUST "notify" the DEA within 1 business day, but the form does not need to be submitted
within that time
DEA Form 222 - CORRECT ANSWER - - Order and transfer form for C-I and C-II
substances. Must be kept for 2 years (NORMAL forms for other CS).
- Must be signed by the most recent pharmacist, but could be bestowed to others via power of
attorney
- Executed DEA Form 222 must be maintained separately
- Defective DEA Form 222 must be replaced by using Form 222a to order more forms and
MUST be returned to the DEA with a reason (illegible or altered)
- Triplate forms:
1. Brown copy goes to supplier (warehouse color)
2. Green copy goes to the supplier (then to DEA, the people making money-green)
3. Blue copy is retained by purchaser which they will then fill out upon receipt of packages
power of attorney - CORRECT ANSWER - must be signed by the registrant and the
person to whom the power of attorney is being granted, and two witnesses
DEA Form 224 - CORRECT ANSWER - - registration form for all pharmacies and
facilities that dispense and possess controlled drugs. must be renewed every 3 years and renewal
notification sent 60 days prior to expiration.
- Form 224a for renewals
, DEA Form 225 - CORRECT ANSWER - Registration form for manufacturers,
distributors, researchers, analytical laboratories, importers, exporters
DEA Form 363 - CORRECT ANSWER - New Application Registration - Narcotic
Treatment Program
DEA registration number - CORRECT ANSWER - - First letter indicates practitioner
status (e.g. A/B/F = practitioner, M = Mid-level practitioner)
- Second letter indicates the first letter of the practitioner's last name/pharmacy name/hospital
name
Verifying DEA number - CORRECT ANSWER - 1. Add 1st, 3rd, and 5th digits together
2. Add 2nd, 4th, and 6th digits together. Multiply by 2
3. Add Step 1 and Step 3 together. The last digit of this sum should match the last digit of the
prescriber's DEA number (Check Digit)
Example: BT6835752
1. 6 + 3 + 7 = 16
2. (8 + 5 + 5) * 2 = 36
3. 16 + 36 = 52 = 2
Temporary use of a DEA registration upon sale of a pharmacy - CORRECT ANSWER --
A new owner may continue the business under the previous owners DEA number.
- The new owner must "expeditiously" apply for an appropriate DEA registration.
- The previous owner is still held accountable, and must sign a power of attorney.
- Can only be in effect for 45 days.
Investigational New Drug Application (IND) - CORRECT ANSWER - Submitted and
approved by the FDA before a drug can be tested in humans. The FDA has 30 days to decide if
the drug is suitable.
