Federal Law MPJE
Red Book - answerDrug pricing and packaging information
The Orange Book - 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 - answerLists biological products that are considered biosimilars and
provides interchangeability evaluations for these products
Pink Book - answerImmunizations, vaccine-preventable diseases, and vaccine safety
Yellow Book - answerCDC's standard resource on travel information
Occupational Safety and Health Administration (OSHA) - answerRequires 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 - answerAdministers the Poison Prevention
Packaging Act (PPPA)
,The Drug Enforcement Administration (DEA) - answerPart of the U.S. Department of
Justice and is responsible for the federal Controlled Substances Act (CSA).
Controlled Substance Ordering System (CSOS) - answerAllows 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 - answer1. 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 - 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 - 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 - 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 - answermust be signed by the registrant and the person to whom the
power of attorney is being granted, and two witnesses
DEA Form 224 - 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 - answerRegistration form for manufacturers, distributors, researchers,
analytical laboratories, importers, exporters
DEA Form 363 - answerNew Application Registration - Narcotic Treatment Program
DEA registration number - 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 - answer1. 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 - 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) - answerSubmitted 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.
Emergency Investigational New Drug Application (EIND) - answerApplications for
Antiviral Products
Treatment Investigational New Drugs - answerAllow investigational new drugs to pts not
enrolled in the clinical trials
*Pts must be in an imminent life-threatening stage of illness with no other cure option
Requires company to present data related to safety & efficacy
Red Book - answerDrug pricing and packaging information
The Orange Book - 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 - answerLists biological products that are considered biosimilars and
provides interchangeability evaluations for these products
Pink Book - answerImmunizations, vaccine-preventable diseases, and vaccine safety
Yellow Book - answerCDC's standard resource on travel information
Occupational Safety and Health Administration (OSHA) - answerRequires 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 - answerAdministers the Poison Prevention
Packaging Act (PPPA)
,The Drug Enforcement Administration (DEA) - answerPart of the U.S. Department of
Justice and is responsible for the federal Controlled Substances Act (CSA).
Controlled Substance Ordering System (CSOS) - answerAllows 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 - answer1. 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 - 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 - 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 - 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 - answermust be signed by the registrant and the person to whom the
power of attorney is being granted, and two witnesses
DEA Form 224 - 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 - answerRegistration form for manufacturers, distributors, researchers,
analytical laboratories, importers, exporters
DEA Form 363 - answerNew Application Registration - Narcotic Treatment Program
DEA registration number - 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 - answer1. 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 - 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) - answerSubmitted 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.
Emergency Investigational New Drug Application (EIND) - answerApplications for
Antiviral Products
Treatment Investigational New Drugs - answerAllow investigational new drugs to pts not
enrolled in the clinical trials
*Pts must be in an imminent life-threatening stage of illness with no other cure option
Requires company to present data related to safety & efficacy
