Federal MPJE (2022/2023) Graded A+
What did the FDCA of 1938 accomplish?
Food, Drug, and Cosmetic Act
1) Drugs must be safe prior to marketing
2) Established the FDA - Food, Drug, Cosmetic, Medical device safety
Durham-Humphrey Amendment of 1951
• Created a distinction between "OTC" and "Legend Drugs/Prescription".
• Authorized verbal prescriptions/refills
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
Kefauver-Harris Amendment of 1962
1) Requires all medications in US to be pure safe and effective.
2) Established the Good Manufacturing Practices (currentGMPs)
Prescription Drug Marketing Act of 1987 (PDMA)
1) Prevents re-importation of a drug into US.
2) Prohibited hospital and healthcare entities from reselling their pharamaceuticals.
3) Prohibits sale, trade, or purchase of Rx samples
4) "Samples Act"
Drug Compounding Quality and Security Act 2013 (DQSA)
,1) Outsourcing (503B) facilities can compound (w/o a prescription) - Regulated by FDA/cGMP
- 503B are exempt from premarket approval, adequate directions for use, and track-and-trace
provisions.
Benefits and restrictions of a 503A facility
503A facilities can pre-emptively compound (anticipatory) but only pursuant to a prescription or
medication order.
Regulated by states/USP standards
Benefits and restrictions of a 503B facility
Outsourcing facility (503B)
Can compound (w/o a prescription)
- Regulated by FDA/cGMP.
- Exempt from: premarket approval, adequate directions for use, and track-and-trace provisions.
- May not compound a bulk drug unless on a shortage or bulk list.
Requirements of a 503B facility
1) Licensed pharmacist to provide direct oversight
2) Register with the FDA as an outsourcing facility
3) Report to HHS every 6 months
4) Report serious adverse events w/in 15 days
5) Label products with a compounded drug statement
What is the difference between distributing and dispensing?
,Distributing: Providing a drug to anyone (other than the patient/consumer.
Dispensing: Providing a drug directly to the patient/consumer.
Drug Supply Chain Security Act (DSCSA)
Framework for national track-and-trace system
Manufacturers are required to provide "transaction data"
Applies to prescription drugs for human use in finished dosage form
Pharmacies must investigate and properly handle suspect and illigitimate products.
What consists of "transaction data"
1) Transaction Information: Drug name, strength, dosage form, NDC, container size, number of
containers, date of transaction, name and address of person from whom and to whom. Serialized
numerical identifier (SNI)
2) Transaction History: Statement including transaction information back to manufacturer
3) Transaction Statement: Statement by the seller that: they are authorized, the person is
authorized, has systems to comply with verification requirements.
What actions should a pharmacy take to handle suspected illigitimate products? (per DSCSA)
Notify FDA using form 3911 within 24 hours and work with manufacturers to prevent products
from reaching patients.
What must pharmacies who are distributing have? Are there exemptions? (per DSCSA)
Wholesale distribution license.
Exemptions:
, 1) Distribution between 2 affiliated entities
2) Patient specific basis
3) Emergency medical reasons
4) "Minimal quantities"
A drug is adulterated if:
1) Contains something bad/decomposed
2) Prepared under unsanitary conditions/may have been contaminated
3) Did not follow cGMP
4) Is stored in a place that inhibits inspection
5) Contains a contaminant or unsafe additive
6) Strength or purity differs from its official compendium or label
A drug is misbranded if:
1) False or misleading label
2) Rx that does not contain:
- Name and address of manufacturer
- Name of drug product
- Net quantity
- Weight of active ingredient per dosage unit
- "Rx only"
- Route of administration
- Storage instructions if appropriate
- Mfg. control number
What did the FDCA of 1938 accomplish?
Food, Drug, and Cosmetic Act
1) Drugs must be safe prior to marketing
2) Established the FDA - Food, Drug, Cosmetic, Medical device safety
Durham-Humphrey Amendment of 1951
• Created a distinction between "OTC" and "Legend Drugs/Prescription".
• Authorized verbal prescriptions/refills
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
Kefauver-Harris Amendment of 1962
1) Requires all medications in US to be pure safe and effective.
2) Established the Good Manufacturing Practices (currentGMPs)
Prescription Drug Marketing Act of 1987 (PDMA)
1) Prevents re-importation of a drug into US.
2) Prohibited hospital and healthcare entities from reselling their pharamaceuticals.
3) Prohibits sale, trade, or purchase of Rx samples
4) "Samples Act"
Drug Compounding Quality and Security Act 2013 (DQSA)
,1) Outsourcing (503B) facilities can compound (w/o a prescription) - Regulated by FDA/cGMP
- 503B are exempt from premarket approval, adequate directions for use, and track-and-trace
provisions.
Benefits and restrictions of a 503A facility
503A facilities can pre-emptively compound (anticipatory) but only pursuant to a prescription or
medication order.
Regulated by states/USP standards
Benefits and restrictions of a 503B facility
Outsourcing facility (503B)
Can compound (w/o a prescription)
- Regulated by FDA/cGMP.
- Exempt from: premarket approval, adequate directions for use, and track-and-trace provisions.
- May not compound a bulk drug unless on a shortage or bulk list.
Requirements of a 503B facility
1) Licensed pharmacist to provide direct oversight
2) Register with the FDA as an outsourcing facility
3) Report to HHS every 6 months
4) Report serious adverse events w/in 15 days
5) Label products with a compounded drug statement
What is the difference between distributing and dispensing?
,Distributing: Providing a drug to anyone (other than the patient/consumer.
Dispensing: Providing a drug directly to the patient/consumer.
Drug Supply Chain Security Act (DSCSA)
Framework for national track-and-trace system
Manufacturers are required to provide "transaction data"
Applies to prescription drugs for human use in finished dosage form
Pharmacies must investigate and properly handle suspect and illigitimate products.
What consists of "transaction data"
1) Transaction Information: Drug name, strength, dosage form, NDC, container size, number of
containers, date of transaction, name and address of person from whom and to whom. Serialized
numerical identifier (SNI)
2) Transaction History: Statement including transaction information back to manufacturer
3) Transaction Statement: Statement by the seller that: they are authorized, the person is
authorized, has systems to comply with verification requirements.
What actions should a pharmacy take to handle suspected illigitimate products? (per DSCSA)
Notify FDA using form 3911 within 24 hours and work with manufacturers to prevent products
from reaching patients.
What must pharmacies who are distributing have? Are there exemptions? (per DSCSA)
Wholesale distribution license.
Exemptions:
, 1) Distribution between 2 affiliated entities
2) Patient specific basis
3) Emergency medical reasons
4) "Minimal quantities"
A drug is adulterated if:
1) Contains something bad/decomposed
2) Prepared under unsanitary conditions/may have been contaminated
3) Did not follow cGMP
4) Is stored in a place that inhibits inspection
5) Contains a contaminant or unsafe additive
6) Strength or purity differs from its official compendium or label
A drug is misbranded if:
1) False or misleading label
2) Rx that does not contain:
- Name and address of manufacturer
- Name of drug product
- Net quantity
- Weight of active ingredient per dosage unit
- "Rx only"
- Route of administration
- Storage instructions if appropriate
- Mfg. control number
