PTCE Laws and Regulations

Kefauver-Harris Amendment of 1962

establishes the scientific safeguards used today by the Food and Drug Administration (FDA) to ensure that consumers will not be the victims of unsafe and ineffective medications.

Food, Drug, and Cosmetic Act of 1938

requires that drugs be labeled with adequate directions for safe use and manufacturers will have to prove to FDA that a drug were safe before it could be sold.

Durham-Humphrey Act of 1951

requires any that is habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the statement, "Caution: Federal law prohibits dispensing without prescription."

Comprehensive Drug Abuse Prevention and Control Act of 1970

brings together a number of laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances.

DEA 222

a form used to order Schedule II medications.

DEA 41

a form for destruction of outdated or damaged controlled substances.

DEA 106

a form for theft of controlled substances.

Occupational Safety and Health Act (OSHA) of 1970

to assure safe and healthful working conditions for working men and women; by authorizing enforcement of the standards developed under the Act; by assisting and encouraging the States in their efforts to assure safe and healthful working conditions; by providing for research, information, education, and training in the field of occupational safety and health; and for other purposes.

Drug Listing Act of 1972

requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution.

Orphan Drug Act of 1983

to stimulate the development of drugs and biological products for the treatment of rare diseases.

1950 Alberty Food Products v. U.S.

U.S. Court of Appeals rules that the directions for use on a drug label must include the drug's purpose.

2003 Medicare Modernization Act

introduced significant changes to the Medicare program, specifically by adding a prescription drug benefit known as Medicare Part D. This Act allows beneficiaries who are enrolled in Medicare under Title XVIII to receive assistance through the Medicare Prescription Drug Discount Card Program, providing discounts on medications. Additionally, it established subsidies to help lower-income individuals cover premiums and cost-sharing expenses associated with Medicare Part D. The Act aimed to improve access to prescription medications for seniors and individuals with disabilities, promoting better health outcomes and reducing out-of-pocket costs for necessary drugs.

DEA 224

form pharmacies use to apply for a new registration with the DEA to dispense controlled substances

DEA 104

form for reporting a pharmacy closure or surrender of a pharmacy permit

How many different items can be placed on one DEA Form 222?

10

Who is required to retain the first page of DEA Form 222?

supplier is required to retain the brown copy

Who is required to retain the second page of DEA Form 222?

The DEA is required to retain the green copy

Who is required to retain the third page of DEA Form 222?

The pharmacy is required to retain the blue copy

Clozaril National Registry

Used record and reference the white blood cell count of patients who take the drug it was established for.

iPLEDGE

focuses on making sure people who are starting isotretinoin therapy are not pregnant and will not become pregnant

THALIDOMID REMS

was established because the drug it was established for causes severe birth defects and venous thromboembolic events.

Tikosyn In Pharmacy System (T.I.P.S.)

was established to communicate the risk of cardiac arrhythmias associated with taking the drug it was established for.

Class I drug recall

This recall is issued when there is a significant chance that the drug could lead to death

Class II drug recall

This recall is issued when there is a probability that the drug could cause temporary adverse health events

Class III drug recall

This recall is issued when adverse health events are not probable

Poison Prevention Packaging Act of 1970 (PPPA)

requires pharmacies and manufacturers to dispense prescription and over-the-counter medications in child-resistant containers to minimize the risk of accidental poisoning in children. Nitroglycerin sublingual tablets and some emergency medications are exempt from the PPPA due to their unique usage and need for immediate accessibility.

The Omnibus Reconciliation Act of 1990 (OBRA '90)

mandates pharmacies to conduct Drug Utilization Reviews (DUR) for Medicaid patients. This includes evaluating patients' medication regimens for potential drug interactions, therapeutic duplications, and contraindications. The act also requires pharmacists to offer counseling to Medicaid patients about their prescriptions, providing important information on proper drug use, possible side effects, and health benefits. OBRA '90 aims to promote the safe and effective use of medications, enhance patient understanding of their therapies, and ultimately improve health outcomes.

The Combat Methamphetamine Epidemic Act of 2005 (CMEA)

requires pharmacies to secure pseudoephedrine products from consumers. CMEA requires pseudoephedrine products to be packaged and sold in blister packs. CMEA limits daily sales of pseudoephedrine to 3.6 grams and monthly sales (30 days) of pseudoephedrine to 9 grams. The federal law limits monthly mail order sales (30 days) of pseudoephedrine to 7.5 grams.

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

requires healthcare providers to keep patients' identifiable and protected health information confidential and establishes national standards for electronic health care transactions. It also aims to improve the portability and continuity of health insurance coverage for millions of Americans, especially for individuals changing jobs or having pre-existing conditions.

Food and Drug Administration (FDA)

Responsible for monitoring the purity, safety, and effectiveness of all pharmaceutical products. It aims to safeguard the public from unsafe pharmaceuticals and ensure that the benefits of the drugs outweigh their risks.

Drug Enforcement Agency (DEA)

primary responsibility is to enforce controlled substances laws and regulations. It is also responsible for assigning medications to the appropriate schedule based on their potential for abuse, medical usefulness, and safety.

United States Pharmacopeia (USP)

a scientific nonprofit organization that sets quality standards for medicines, food ingredients, and dietary supplements in the United States. USP develops and publishes official standards for drug substances, drug products, excipients, and dietary supplements to ensure they are of the highest quality, purity, strength, and consistency.It plays a critical role in promoting public health by establishing standards that manufacturers must follow.

The Joint Commission (TJC)

is responsible for accrediting healthcare organizations for meeting and maintaining specific performance standards, which include the proper use of laminar flow hoods, personal hygiene requirements, and disposal of waste. The Joint Commission does not certify retail pharmacies.