Federal Laws And Regulations Flashcards

1
Q

Agencies governing Pharmacy Law

A

1) FDA
- Manages the drug approval process for both prescription and non-prescription drugs
- Manages drug manufacturing and distribution
- Drug Safety

2) DEA - Drug Enforcement Administration
- Responsible for enforcing the Controlled Substances Act
- Placing drugs into their schedules

3) Consumer Product Safety Commission
- Regulates OTC drug labeling and child resistant packaging

4) Federal Trade Commission
- Regulates OTC drug ads

5) Centers for Medicare and Medicaid Services (CMS)
- Regulates state and federally funded health programs

6) Department of Health and Human Services
- Oversees the FDA and CMS

7) State Board of Pharmacy
- Grant and Revoke Licenses
- Alter Federal laws to meet state-specific needs
- Enforce pharmacy practice regualtions

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2
Q

What is a misbranded drug?

A

1)A LABEL is:
-False or misleading
-Missing name, active ingredients, quantity
-Label is missing required information
2) The drug is made in a non-registered facility
3) Not in compliance with laws or regulations
4) Packed without regard to Poison Prevention Packaging Act

Misbranding “Something is wrong with the labeling”
-Label is lacking required information or illegible
-False or misleading label or advertising
-Improper packaging
-Ingredients differ form USP monograph standards

*Dispensing adulterated or misbranded drugs is considered illegal

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3
Q

What is an adulterated drug?

A

1) Contains any unapproved, unsafe substance
2) Exposed to unsanitary conditions or lack of cGMPs
3) Strength, purity or quality standard is false
4) Used in substitution of another substance

Adulteration “Something is wrong with the drug”
-Product is filthy, putrid, decomposed or contaminated
-Drug is prepared or stored under unsanitary conditions
-Lack of quality control or purity testing
-Strength or quality is different than official standards or labeling

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4
Q

Largest of FDA’s 6 centers

A

Center for Drug Evaluation and Research (CDER)

*Drug approval is based on safety and efficacy

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5
Q

Prescription Drug Approval Process

A

1) Pre-clinical
- This is testing on animals
- Must prove safety with potential therapeutic use
- If yes to above, the manufacturer will file an IND (Investigational New Drug)

2) Phase 1
- Needs IND approval to move into Phase 1
- 20-100 HEALTHY volunteers or people without the disease
- Used to determine toxicology, safety, metabolism, MOA, and early evidence of effectiveness.

3) Phase 2
- 100’s of subjects from the PATIENTS WITH THE DISEASE
- Used to determine the compound’s effectiveness against the targeted disease and safety

4) Phase 3
- 1000’s of patients from multiple drug centers
- The drug is compared to Placebo/Standard of Care
- Goal: Adverse events
- Application for FDA approval begins. NDA (New Drug Application) or BLA (Biologics License Application)

5) Phase 4 (aka. Post Marketing Surveillance)
- Long term surveillance
- Long-term safety and efficacy
- High-risk patient monitoring

*ALL PHASES ASSESSES THE DRUG’S SAFETY

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6
Q

OTC Drug Approval

A

Can be approved by:
1) NDA - full review by the FDA
2) OTC Monograph Process
-FDA has standard monographs for drugs generally recognized as safe and effective
-FDA review not required if monograph for therapeutic class followed

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7
Q

How to get a Generic Drug Approval?

A

1) Abbreviated New Drug Application (aNDA)

*Excipients/inactive ingredients can vary
-Must be proven bioequivalent

2) 505b2 Application
-In this application, the strength or formulation can be different than the reference drug

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8
Q

Is it possible for unapproved drugs to be on the market?

A

YES

This may be because it was available before 1938
-The FDA is working on bringing the unapproved drugs through the approval process

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9
Q

Is there a way the FDA monitors the drugs Post-Approval?

A

YES

1) MedWatch
2) FDA Adverse Event Reporting System (FAERS)
3) Risk Evaluation and Mitigation Strategy (REMS)

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10
Q

Why are withdrawal of drugs done?

A

*Done by manufacturer

1) Safety or efficacy concerns
2) Lack of profitability
3) Manufacturing problems

*Manufacturer should notify the FDA

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11
Q

Who regulates Prescription drug advertising?

A

FDA

Items required by the FDA:
-Name of Drug
-At least 1 approved use
-Most significant risk

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12
Q

Who regulates OTC drug advertising?

A

Federal Trade Commission (FTC)

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13
Q

List of All Pharmacy Acts

A

1) 1906 - Pure Food and Drug Act (The Wiley Act)
2) 1914 - The Harrison Narcotic Act
3) 1938 - Food, Drug and Cosmetic Act
4) 1945 - Penicillin Amendment
5) 1951 - Durham-Humphrey Act
6) 1962 - Kefauver-Harris Act
7) 1965 - Drug Abuse Control Amendment
8) 1970 - Drug Abuse Prevention and Control Act (Controlled Substances Act)
9) 1972 - Drug Listing Act
10) 1982 - Federal Anti-tampering Act
11) 1983 - Orphan Drug Act
12) 1984 - Hatch-Waxman Act (Drug price competition and Patent term restoration Act)
13) 1988 - Prescription Drug Marketing Act (PDMA)
14) 1990 - Omnibus Budget Reconciliation Act (OBRA ’90)
15) 1994 - Dietary Supplement Health and Education Act (DSHEA)
16) 1997 - FDA Modernization Act (FDAMA)
17) 1998 - Pediatric Rule
18) 2000 - The Drug Addiction Treatment Act (DATA 2000)
19) 2009 - The Biologics Price Competition and Innovation Act
20) 2010 - Affordable Care Act
21) 2013 - Drug Quality and Security Act (DQSA)
22) 2016 - The Comprehensive Addiction and Recovery Act (CARA)
23) 2018 - Lowest Price Act
24) 2020 - Drug Supply Chain Security Act (DSCSA)
25) 2020 - COVID-19 and PREP Act
26) 2023 - Consolidated Appropriations Act

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14
Q

What is the Pure Food and Drug Act (Wiley Act)?

A

1906

-Food/drug label cannot be false or misleading
-No adulterated or misbranded drugs through interstate commerce
-Recognition that USP and NF are standards

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15
Q

What is The Harrison Narcotic Act?

A

1914

-Requires prescriptions for products exceeding the allowable limit of narcotics
-Mandates increased record-keeping for physicians and pharmacists who dispense narcotics.

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16
Q

What is the Food, Drug and Cosmetic Act?

A

1938

-Passed because of 107 deaths due to Sulfonamide Elixir
-Requiring new drugs to be proven safe before marketing; starting a new system of drug regulation.
-FDA given authority to approve drugs and conduct inspections
-Labeling requirements
-Extends control to cosmetics and therapeutic devices.
-Eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases.
-Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions.

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17
Q

What is the Penicillin Amendment?

A

1945

-Required FDA testing and certification of the safety and effectiveness of all penicillin products. –Later amendments extended this requirement to all antibiotics.

18
Q

What is the Durham-Humphrey Amendment?

A

1951

-Distinction made between OTC and prescription drugs including labeling requirements for each

-Requires “Caution: Federal law prohibits dispensing without a prescription” (later “Rx only”)

19
Q

What is the Kefauver-Harris Drug Amendment?

A

1962

-Thalidomide tragedy: marketed as a safe anti-nausea drug in pregnancy, is found to have caused birth defects in thousands of babies born in western Europe

-For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them
-Requires adverse events reporting
-Informed consent for clinical trials
-FDA can enforce CGMP
-FDA can regulate advertising of Rx drugs

20
Q

What is the Drug Abuse Control Amendments?

A

1965

  • Enacted to deal with problems caused by abuse of depressants, stimulants, and hallucinogens
21
Q

What is the Drug Abuse Prevention and Control Act?

A

1970

-aka. Controlled Substances Act
-Replaces previous laws
-Categorizes drugs based on abuse and addiction potential compared to their therapeutic value.

22
Q

What is the Drug Listing Act?

A

1972

-Each prescription and OTC drug must be registered with the FDA
-Drugs are assigned a unique 10 or 11-digit national drug code (NDC)

*NDC Number breakdown:

12345-6789-01
“12345” - Labeler Code (Manufacturer)
“6789” - Product Code (Strength , dose and formulation)
“01” - Package Code

23
Q

What is the Anti-Tampering Act?

A

1982

-Issued by FDA to prevent poisonings after many died after cyanide placed in Tylenol capsules
-Federal crime to tamper with OTC products
-Tamper-resistant features on OTC meds

24
Q

What is the Orphan Drug Act?

A

1983

-Provided incentives for manufacturers to develop drugs for rare diseases
-Conditions affecting <200,000 people in the USA
-Tax credits and 7-year exclusivity for manufacturers

25
Q

What is the Hatch-Waxman Act?

A

1984

-Encouraged cheaper generic alternatives to brand names by permitting the FDA to approve applications to market generic drugs without repeating the research to prove that they are safe and effective.
-Streamlined generic drug approvals
-5 year exclusivity for brand drugs
-Interchangeable generics listed in Orange Book

26
Q

What is the Prescription Drug Marketing Act?

A

1988

-No reimportation of drugs from outside US except by manufacturer
-Patients cannot buy drugs in other countries and bring them into the US except under these conditions:
1) < 90 day supply for the patient’s own use
2) Effective treatment is not available in the US
3) Condition is serious
4) Drug has no unreasonable risk

-Sales of drug samples and coupons prohibited
-Limited reselling of drugs by hospital
-Wholesalers must be registered in each state

27
Q

What is the Omnibus Budget Reconciliation Act (OBRA)?

A

1990

-Pharmacists must perform prospective DUR
-Counseling for Medicaid beneficiaries
-States must have retrospective DUR programs

28
Q

What is the Dietary Supplement Health & Education Act (DSHEA)?

A

1994

-FDA approval is not required for supplements unless product contains a new dietary ingredient

-Supplements may only claim to
1) Address a nutrient deficiency
2) Support overall health
3) Be linked to body functions
*Not cure a disease

*A disclaimer is required if structure/function claims are made
[This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

29
Q

What is the FDA Modernization Act?

A

1997

-Extended Prescription Drug User Fee Act (PDUFA): FDA can charge fees to manufacturers for expedited reviews
-It established a Clinical Trials database (clinicaltrails.gov)
-Legend shortened to “Rx Only”
-Updated regulations for fast track and other expedited approvals

30
Q

What is the Pediatric Rule?

A

1998

-Requires manufacturers of selected drugs to conduct studies to assess their safety and efficacy in children.

31
Q

What is the Drug Addiction and Treatment Act (DATA 2000)?

A

2000

-Allowed physicians to dispense and prescribe opioid addiction treatments in the office setting

32
Q

What is the Biologics Price Competition & Innovation Act?

A

2009

-Created an abbreviated pathway for biosimilar approval
-Listed in Purple Book

*Because of the complexity of biologics, true generics are nearly impossible. The closest we can get is to create a biosimilar.
*Biosimilars must have the same MOA, dosage form, Strength and Indication

33
Q

What is the Affordable Care Act (ACA)?

A

2010

-Aimed at improving quality care while decreasing cost

34
Q

What is the Drug Quality and Security Act (DQSA)?

A

2013

-An amendment to the FDCA
-2 parts: Compounding Quality Act & Drug Supply Chain Security Act
-Compounding Quality Act gave the FDA increased authority to regulate compounding.
-In 2012, an outbreak of fungal meningitis linked to a contaminated compounded drug product resulted in the loss of 64 lives and caused more than 751 illnesses
-FDA to regulate compounding (separated traditional 503A and outsourcing facilities 503B compounders)
-Required documentation regarding prescription drugs

503A: Traditional Compounders (compounds for individual patients based on prescription)

503B: Outsourcing Facilities (makes larger batches of sterile compounds that are distributed to hospitals and other facilities. 503B regulations do not require that prescriptions be obtained for individual patients. If a facility compounds sterile compounds for humans, they can register as a 503B facility.

TO prevent counterfeiting, the Drug Supply Chain Security Act established a ‘track and trace’ system. Records must be kept for 6 years, and must include transaction information, history and statements.

35
Q

What is the Comprehensive Addiction & Recovery Act (CARA)?

A

2016

-Authorizes over $181 million each year to respond to the epidemic of opioid abuse.
-Increased availability of:
1) Prevention/education
2) Addiction treatment
3) Naloxone

-Allowed partial fill of schedule 2 drugs
1) Patient or provider can request
2) Must be filled within 30 days of issue

36
Q

What is the Lowest Price Act?

A

2018 (effective 2020)

-Enforces any Medicare prescription drug (Part D) plans to NOT PREVENT a pharmacy from notifying a customer if they could pay a lower price for a drug without insurance. The pharmacy cannot be penalized for taking such an action, either in notifying a customer of lower drug prices.

37
Q

What is the Drug Supply Chain Security Act (DSCSA)?

A

2020

-Serial numbers to track and trace drugs from manufacturer to dispenser.

NOTE:
- Pharmacists should check the following:
1) Registration of manufacturers and re-packagers
2) Licensing of wholesaler-distributors and third-party logistics providers
3) Licensing of pharmacies through the state

Pharmacies should only accept prescription drugs that have the following three product tracing documentation:
1)Transaction information
2) Transaction history
3) Transaction statement.
The product tracing documentation must be stored in paper or electronic format for 6 years.

38
Q

What is the COVID-19 and PREP Act?

A

2020

-Declares COVID-19 a public emergency
-HHS releases guidance for qualified technicians to administer childhood vaccinations, COVID-19 vaccinations, and perform COVID-19 testing

*Pharmacy Intern and Pharmacy Technician must be under pharmacist supervision to
1) Administer all vaccines to patients 3-18 y.o.
2) Order and administer COVID-19 vaccines 3+
3) Order and administer COVID-19 tests

39
Q

What is the Consolidated Appropriations Act?

A

2023

-Removes the federal responsibility for providers or practitioners to apply for a special (DATA) waiver to treat patients with buprenorphine for opioid use disorder (OUD).
-All buprenorphine prescriptions will now require a standard DEA registration number.
-This act does not change or impact the treatment of methadone for opioid use disorder

40
Q

What is the Consumer Bill of Rights?

A

1962

-Proclaimed by JFK in a message to congress
-Included is the right to safety, right to be informed, the right to choose, and the right to be heard.

41
Q
A