PTCB - Pharmacy Laws
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
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
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.
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
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
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
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
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
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
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
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
Drug listing act of 1972
Establish the NDC (National Drug Code) number 5 - 4 - 2 First 5: the manufacturer 2nd 4: the drug product Final 2: package size and packaging
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
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
FDA stands for what regulatory agency? What is its responsibilities?
Food and Drugs administration Ensure that all pharmaceutical products are pure, safe, and effective
Resources Conservation and Recovery Act
From the Environmental Protection Agency (EPA) federal guidelines regarding the disposal of hazardous waste
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
Anabolic Steroid control act of 1990
Harsher penalties for the abuse of anabolic steroids and their misuse by Athletes
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
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
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
Combat Methamphetamine epidemic Act of 2005
Place Ephedrine, pseudoephedrine, and Phenyl-propanolamine in the Controlled Substances in Schedule Impose sale and production restrictions
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.
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
Orphan Drug Act of 1982
Provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan medication
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
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
Kefauver-Harris Amendment of 1962
Requires all medication in the US to be pure, safe, and effective
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
Omnibus Budget Reconciliation act of 1987 (OBRA 87)
Revision to Medicare and Medicaid Conditions of participation regarding long term care facilities and pharmacy.
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.
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...
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
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
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
USP <797>
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
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.
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
Orphan medication
medications for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world.
Prescription Drug Equity Law
prohibit a prescription drug plan from requiring mail order prescription drug coverage without also providing non-mail order coverage
Pure food and drugs act of 1906
prohibit the interstate transportation or sale of adulterated or misbranded food or drugs
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
