Pharmacy Laws: 2025 PTCB exam

Pure food and drugs act of 1906

prohibit the interstate transportation or sale of adulterated or misbranded food or drugs

What does Adulterated mean?

Consists of any filthy, decomposed, putrid susbtance
Perpared, packed, or help under unsanitary conditions
Perpared in containers composed of any poisonous or deleterious substance
Containing unsafe color additives
Recognized in an official compendium but differing in strength, quality, or purity of the drugs

What does Misbranding mean?

False labeling
No label
Label lacks Name, place of business of the manufacturer/packer/distributor, lack accurate quantity of contents.
No Warning if the product is habit forming
No labeled direction for use and no warning against certain pathological conditions
Products that are dangerous to health under the labeled dosage
No ingredient/alcohol content if have alcohol
Failed to bear the established name of the drug

Durham-Humphrey Act of 1951

Amendment of FDCA 1938
Require all products to have adequate directions for use
Don't need to have adequate directions for use if the drug/products must be dispense with a prescription (not over-the-counter)
Separated drugs into Legend and Nonlegend (over the counter)
Allows verbal prescriptions over the phone
Allows refills to be called in from a doctors' office

Food, Drugs, and Cosmetic Act of 1938 (FDCA)

Created the US Food and Drug Administration (FDA)
Required all new drug applications be filed with the FDA
Clearly defined Adulteration and misbranding

Kefauver-Harris Amendment of 1962

Requires all medication in the US to be pure, safe, and effective

Comprehensive drugs abuse prevention and control act of 1970

Established "Controlled substance" rating
Created the Drug Enforcement Agency (DEA)
Separated the controlled substance into 5 Schedule based on potential for abuse and accepted medical use in the US

Prescription monitoring programs. the federal National All Schedules Prescription Electronic Reporting Act in 2005

The Act establish an electronic system for practitioner monitoring of the dispensing of controlled substances in SCH 2, 3, 4. The act would require specific information to be reported. But the act was never enacted at the federal level. But many states have enacted similar legislation.

Poison prevention packaging act of 1970

to reduce accidental poisoning in children.
Requires that most OTC and legend drugs be packaged in child-resistant containers --> can't be opened by 80% of children <5 yrs old but can be opened by 90% of adults.

Occupational safety and health act (OSHA) of 1970

Created the Occupational Safety and Health Administration (OSHA)
OSHA ensures a safe and healthful workplace for all employees
Ensures job safety and health standards for employees
Maintain a reporting system for job-related injuries and illness, reduce hazards in the workplace, and conduct audits to ensure compliance with the Act
Address Air contaminants, flammable, and combustible liquids, eye and skin protection, and hazard communication standards.
Requires the MSDS to be use

Drug listing act of 1972

Establish the NDC (National Drug Code) number
5

Orphan Drug Act of 1982

Provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan medication

Orphan medication

medications for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world.

Drug Price Competition and Patent term restoration act of 1984

encouraged the creation of both generic and new medications
streamlining the process for generic drug approval and by extending patent licenses.

Prescription Drug marketing act of 1987

prohibits the re-importation of a drug into the US by anyone except the manufacturer.
prohibits the sale or distribution of samples to anyone other than those licensed to prescribe them
Required labels to appear on all medication for animals

Omnibus Budget Reconciliation act of 1987 (OBRA 87)

Revision to Medicare and Medicaid Conditions of participation regarding long term care facilities and pharmacy.

Anabolic Steroid control act of 1990

Harsher penalties for the abuse of anabolic steroids and their misuse by Athletes

Omnibus Budget Reconciliation Act of 1990 (OBRA-90)

Required manufacturers to provide the lowest prices to any customer or medicaid patient by rebating each state Medicaid agency the difference between its average price and the lowest price
Offer to counsel is made to every patient and drug utilization review is performed for every patient --> failure to do so may result in loss of medicaid funding
Authorizes government-sponsored demonstration project relating to the provision of pharmaceutical care

FDA Safe Medical devices Act of 1990

Requires that all medical devices be tracked
Records be maintained for durable medical equipment such as infusion pumps

American with Disabilities Act (ADA) of 1990

Prevent discrimination against potential employees who may possess a disability.
Must make a reasonable accommodation for the potential employee.

Resources Conservation and Recovery Act

From the Environmental Protection Agency (EPA)
federal guidelines regarding the disposal of hazardous waste

FDA modernization Act

Replace the Federal Drug legend "Federal Law prohibits the dispensing of this medication without a prescription" with the Rx abbreviation.
An update of the Humphrey Act

Dietary Supplement Heath and Education Act (DSHEA) of 1994

Guideline to prevent Adulteration of Herbal products and Dietary supplements
Must be labeled as Dietary supplements
identifies all ingredients and quantities of the ingredient in the label
Packaging that identifies the plant and plant part that derives the ingredients
Meet the quality, purity and compositional specification

HIPAA of 1996

improve portability and continuity of health coverage in the group and individual markets
Combat waste, fraud, and abuse in health insurance and delivery
Promote use of medical saving accounts
Improve access to long term care services and coverage
Simplify the administration of health insurance
Maintain patient confidentiality

Isotretinoin safety and risk management act of 2004

Isotretionoin (Accutane) is a medication used to treat acne that cause sever birth defect and psychiatric effects
The act helps control the use of Accutane

Anabolic Steroid Control act of 2004

An update to the Same Act of 1990.
New definition of anabolic steroid
SCH 3 medications
Eliminate requirement to prove muscle growth.
Increase the number of anabolic steroids to 59 substances
Also implement requirement for handling and recording of the use of anabolic steroids substances

Any willing provider Law

allows any pharmacy to participate in a prescription drug benefit plan as long as the pharmacy agrees to the terms and conditions of the plan

Freedom of choice law

allows a member of a prescription drug plan to select any pharmacy as long as the pharmacy agrees to the terms and conditions of the plan

Freedom of choice with regard to long term care

Long term care residents may choose an outside pharmacy for their medication if the pharmaceutical service is not provided under their contract.
However the long term care facility may refuse admission to a resident if the resident refuses to use the drug distribution system already in place
The facility may have additional policies that the outside pharmacy must agree to

Prescription Drug Equity Law

prohibit a prescription drug plan from requiring mail order prescription drug coverage without also providing non-mail order coverage

Medicare Drug improvement and modernization act of 2003

Provide voluntary prescription drug benefit to medicare beneficiaries
Part B and Part D prescription plan
Add preventive medical benefits to senior citizens

Combat Methamphetamine epidemic Act of 2005

Place Ephedrine, pseudoephedrine, and Phenyl-propanolamine in the Controlled Substances in Schedule
Impose sale and production restrictions

Medicaid Tamper0resistant Prescription Act

2008
Special Prescription pad for any prescription that are paid by Medicaid (any portion)
Prevent unauthorized copying of the prescription form and modification of the prescription
Prevent counterfeit prescription forms

USP

designed to cut down on infection transmitted to patients through pharmaceutical products and better protect staff working in pharmacies
Contain procedural training and quality assurance requirements for preparing sterile products

ATF stands for what regulatory agency? What is its responsibilities?

Bureau of Alcohol, Tobacco and FireArms
Set regulations regarding the purchase of tax-free alcohol (use in hospitals and clinics)

CMS stands for what regulatory agency? What is its responsibilities?

Centers for Medicare and Medicaid Services
Oversees medicare and medicaid

DEA stands for what regulatory agency? What is its responsibilities?

Drug Enforcement Agency
Enforces compliance with the Controlled Substance Act
It places medications into the appropriate schedule, monitor records, and reports of controlled substances, registering pharmacies, issuing Form 222 and 41, and monitor the destruction of controlled substances
DEA is overseas by Department of Justice

FDA stands for what regulatory agency? What is its responsibilities?

Food and Drugs administration
Ensure that all pharmaceutical products are pure, safe, and effective

Institutional Review Board stands for what regulatory agency? What is its responsibilities?

A board, committee, or other group designated by an institution to approve biomedical research in accordance with the FDA

TJC stands for what regulatory agency? What is its responsibilities?

The Joint Commission
address quality of patient care and patient safety.
establish standard and accredits health care providers (places): hospital, home health care agencies, long term care pharmacies…

NABP stands for what regulatory agency? What is its responsibilities?

National Association of The Boards of Pharmacy
Composed of all State Boards of Pharmacy.
No regulatory authority but meets to discuss current trends and issues in pharmacy that affect the practice of pharmacy

BOP stands for what regulatory agency? What is its responsibilities?

State Boards of Pharmacy
Regulatory state agency that oversees the practice of pharmacy in a given state

USP stands for what regulatory agency? What is its responsibilities?

United States Pharmacopeia
official public standards-setting authority for all prescription and oTC medicines and other health care products manufactured or sold in the US
Set standards for food ingredients and dietary supplements