Drug Acts - HOSA // pharmacy science

1906 Federal and Food Drug Act

The 1906 Pure Food and Drug Act was a U.S. law that aimed to regulate food and medicine by prohibiting the sale of adulterated or mislabeled products. It required manufacturers to accurately label ingredients and outlawed harmful additives or false claims about a product’s effects.

This act led to the creation of the Food and Drug Administration (FDA) and was an early step in federal consumer protection laws. It was influenced by public outrage over unsanitary conditions in food production, especially after Upton Sinclair’s book The Jungle exposed the meatpacking industry's horrors.

1914 Harrison Narcotic Act

The 1914 Harrison Narcotic Act was a U.S. law that regulated and taxed the production, importation, and distribution of opium, heroin, morphine, and cocaine. It required doctors, pharmacists, and distributors to register and pay taxes for handling these substances.

Although the law was initially meant for regulation, it later led to criminalization as stricter interpretations made it illegal for doctors to prescribe narcotics to addicts, treating addiction as a crime rather than a medical condition. This act was a key step in the U.S. government's efforts to control drug use.

1938 Food Drug and Cosmetic Act

The 1938 Food, Drug, and Cosmetic Act (FDCA) was a major expansion of U.S. consumer protection laws, strengthening regulations on food, drugs, and cosmetics. It was passed after the 1937 Elixir Sulfanilamide disaster, where a toxic drug formulation killed over 100 people.

Key provisions of the act:

• Required drug manufacturers to prove safety before marketing their products.

• Gave the FDA authority to inspect factories and enforce standards.

• Mandated proper labeling with accurate ingredient lists and usage instructions.

• Regulated cosmetics and medical devices for the first time.

This act laid the foundation for modern drug approval processes and consumer safety laws.

1951 Durham Humphrey Amendment

The 1951 Durham-Humphrey Amendment to the 1938 Food, Drug, and Cosmetic Act established the legal distinction between prescription and over-the-counter (OTC) drugs in the U.S.

Key provisions:

• Required drugs that are potentially dangerous or habit-forming to be dispensed only with a doctor’s prescription.

• Allowed pharmacists to sell OTC drugs without a prescription.

• Mandated that prescription drugs carry the label: "Caution: Federal law prohibits dispensing without a prescription."

This amendment clarified drug regulations and ensured that certain medications could only be used under medical supervision.

1962 Kefauver-Harris Amendment

The 1962 Kefauver-Harris Amendment, also known as the Drug Efficacy Amendment, significantly strengthened U.S. drug regulation. Prompted by the thalidomide tragedy, where the drug caused severe birth defects in thousands of infants worldwide, this amendment required drug manufacturers to provide proof of both safety and effectiveness before a drug could be approved for marketing. It also mandated that drug advertising disclose accurate information about side effects and efficacy, and required informed consent from patients participating in clinical trials. This legislation marked a pivotal shift toward more rigorous pharmaceutical oversight in the United States.

1970 Drug Abuse Prevention and Control Act (Controlled Substance Act-CSA)

The 1970 Drug Abuse Prevention and Control Act, commonly known as the Controlled Substances Act (CSA), established the modern framework for regulating drugs in the United States.

Key provisions:

• Created the drug scheduling system (Schedules I–V) based on a drug's potential for abuse, medical use, and safety.

  • Schedule I: High potential for abuse, no accepted medical use (e.g., heroin, LSD, marijuana).

  • Schedule II–V: Decreasing potential for abuse and increasing accepted medical use (e.g., oxycodone, Xanax).

• Gave the DEA (Drug Enforcement Administration) authority to enforce drug laws and regulate controlled substances.

1970 Poison Prevention Packaging Act

The 1970 Poison Prevention Packaging Act (PPPA) was a U.S. law designed to protect children from accidental poisoning by requiring child-resistant packaging for certain household substances.

Key Provisions:

• Required child-resistant packaging for prescription drugs, over-the-counter medications, and hazardous household products (e.g., cleaning supplies, pesticides).

• Packaging had to be designed so that 80% of children under five could not open it, but 90% of adults could.

• Allowed exceptions for some medications if a patient or physician requested non-child-resistant packaging (e.g., for elderly or disabled individuals).

This law significantly reduced accidental poisonings, particularly among young children.

1970 Patient Package Inserts

The 1970 Patient Package Inserts (PPI) regulation required that certain medications come with informational leaflets to educate patients about their use, risks, and side effects.

Key Provision:

• Required drug manufacturers to provide package inserts for specific medications, especially those with serious risks (e.g., birth control pills).

• Inserts had to include dosage instructions, potential side effects, risks, and precautions.

• Aimed to increase patient awareness and safety by ensuring they had clear, accessible information about their medications.

This regulation marked a shift toward greater patient education and informed consent in medical treatments.

1972 Drug Listing Act

The 1972 Drug Listing Act required all drug manufacturers to register their products with the U.S. Food and Drug Administration (FDA).

Key Provisions:

• Mandated that manufacturers submit a list of all drugs they produced or marketed, including chemical formulations and identifying codes.

• The FDA created a National Drug Code (NDC) system to track drugs and ensure consistency in identification.

The act helped improve drug regulation, monitoring, and enforcement, making it easier to identify and track drugs in the marketplace.

1976 Medical Device Amendment of 1976

The Medical Device Amendments of 1976 significantly expanded the U.S. Food, Drug, and Cosmetic Act to include regulation of medical devices.

Key Provisions:

• Created a classification system for medical devices based on their risk, dividing them into Class I (low risk), Class II (moderate risk), and Class III (high risk, such as pacemakers).

• Required premarket approval for high-risk devices (Class III) to ensure their safety and effectiveness.

• Established guidelines for the manufacturing, labeling, and marketing of medical devices.

• Gave the FDA authority to inspect manufacturing facilities and enforce standards for medical devices.

The amendment provided a stronger regulatory framework to ensure the safety and reliability of medical devices used in healthcare.

1983 Orphan Drug Act

The 1983 Orphan Drug Act was a U.S. law designed to encourage the development of drugs for rare diseases (also known as "orphan diseases"), which affect a small number of people.

Key Provisions:

• Provided financial incentives to pharmaceutical companies, such as tax credits for clinical research and market exclusivity for seven years for drugs that treat rare conditions.

• Defined an orphan drug as one that treats a condition affecting fewer than 200,000 people in the U.S.

• Streamlined the approval process for orphan drugs, making it easier for companies to bring these treatments to market.

This law significantly increased the number of treatments available for rare diseases and has led to the approval of many orphan drugs over the years.

1984 Drug Price Competition and Patent- Term Restoration Act (Hatch- Waxman Amendment)

The 1984 Drug Price Competition and Patent-Term Restoration Act, also known as the Hatch-Waxman Amendment, aimed to balance the need for affordable generic drugs with incentives for innovative drug development.

Key Provisions:

• Streamlined the approval process for generic drugs, allowing them to be marketed once the brand-name drug’s patent expired, without having to repeat costly clinical trials.

• Established a system where generic drug manufacturers could submit an Abbreviated New Drug Application (ANDA) to demonstrate that their product is bioequivalent to the brand-name drug.

• Extended patent protection for brand-name drugs by up to five years if the drug manufacturer could prove that additional testing (such as pediatric studies) was required.

• Facilitated competition by reducing barriers for generics, lowering overall drug prices.

The Hatch-Waxman Amendment helped increase the availability of lower-cost generics while still providing protections and incentives for innovation in drug development.

1987 Prescription Drug Marketing Act

The 1987 Prescription Drug Marketing Act (PDMA) was a U.S. law aimed at ensuring the safety and integrity of the drug supply chain by regulating the distribution of prescription drugs.

Key Provisions:

• Prohibited the reimportation of prescription drugs into the U.S. (except by the original manufacturer), to prevent the entry of drugs from unregulated sources.

• Banned the sale of drug samples (except under specific circumstances), aiming to prevent the diversion of prescription drugs for illegal resale.

• Required state licensing of drug wholesalers to prevent counterfeit and substandard drugs from entering the market.

• Mandated tracking and record-keeping for the distribution of prescription drugs, increasing accountability in the supply chain.

The PDMA helped enhance drug safety by reducing the risk of counterfeit or diverted drugs reaching consumers.

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1988 Food and Drug Administration Act

The 1988 Food and Drug Administration Act (also known as the FDA Revitalization Act) was designed to strengthen the authority of the U.S. Food and Drug Administration (FDA) and improve its ability to protect public health.

Key Provisions:

• Increased FDA authority over the regulation of food, drugs, and medical devices, including the ability to impose fines for non-compliance.

• Expanded the FDA’s role in regulating the safety of blood and blood products.

• Improved FDA oversight on the production and distribution of prescription drugs and medical devices.

• Established new user fees for drug and medical device companies to speed up the approval process, which helped fund the FDA’s activities and reduce delays in bringing products to market.

This act significantly enhanced the FDA’s regulatory power, helping it better protect the public from unsafe drugs and products while facilitating more efficient product approval processes.

1990 Anabolic Steroid Control Act

The 1990 Anabolic Steroid Control Act was a U.S. law that aimed to regulate and control the use of anabolic steroids and related substances, which were being abused by athletes and bodybuilders for performance enhancement and muscle growth.

Key Provisions:

• Classified anabolic steroids as controlled substances under Schedule III of the Controlled Substances Act, making their use, distribution, and possession illegal without a prescription.

• Targeted substances that were chemically similar to testosterone and had the potential for abuse or health risks, including physical and psychological harm.

• Provided penalties for trafficking and possession of anabolic steroids without a prescription, aiming to curb their illegal use.

This law was part of efforts to reduce the misuse of performance-enhancing drugs and protect athletes' health from the harmful effects of steroid abuse.

1996 (HIPAA) Health Insurance Portability and Accountability Act

The 1996 Health Insurance Portability and Accountability Act (HIPAA) is a U.S. law designed to improve the efficiency and effectiveness of the healthcare system while protecting patient privacy and health data.

Key Provisions:

1. Privacy Rule: Established standards for the protection of health information (PHI) and set requirements for the confidentiality of patient data, ensuring that healthcare providers and insurers maintain the privacy of personal health information.

2. Security Rule: Outlined measures for the security of electronic health information (ePHI), mandating healthcare entities to safeguard patient data from unauthorized access or breaches.

3. Portability: Allowed individuals to maintain health insurance coverage when changing or losing jobs, ensuring that workers and their families would not lose coverage during transitions.

4. Administrative Simplification: Created standards to streamline and simplify the process of electronic health transactions (e.g., billing, claims processing), reducing costs and inefficiencies in the healthcare system.

HIPAA played a key role in protecting patient rights, improving the security of medical records, and increasing the efficiency of healthcare transactions.

1990 Omnibus Budget Reconcilliation Act (OBRA)

The 1990 Omnibus Budget Reconciliation Act (OBRA) was a major piece of legislation that included a variety of provisions, but it is particularly known for its impact on healthcare policy and pharmacy practice.

Key Provisions:

1. Medicaid Reforms: OBRA 1990 made significant changes to the Medicaid program, including requiring states to implement more cost-effective and quality-driven practices.

2. Pharmacy Regulations:

   • Drug Use Review (DUR): Established a requirement for states to implement prospective drug use review (DUR) to ensure that prescriptions are appropriate, medically necessary, and not likely to result in adverse effects.

   • Counseling Requirement: Required pharmacists to offer counseling to patients regarding medications they were prescribed, ensuring they understood dosage, side effects, and proper use.

3. Expansion of Coverage: OBRA 1990 also worked to expand coverage and improve healthcare quality for low-income individuals, including provisions to improve the accessibility of services.

This law had a significant impact on healthcare delivery, particularly for Medicaid recipients, and improved pharmacy practices by promoting safety and patient education.

1994 Dietary Supplement Health and Education Act (DSHEA)

The 1994 Dietary Supplement Health and Education Act (DSHEA) was a law that regulated dietary supplements in the United States, aiming to clarify and expand the market for supplements while ensuring consumer safety.

Key Provisions:

1. Defined Dietary Supplements: DSHEA defined dietary supplements as products intended to supplement the diet, including vitamins, minerals, herbs, amino acids, and other substances. These products were classified separately from food and drugs.

2. Regulated Claims: The law allowed manufacturers to make structure-function claims (e.g., “supports immune health”) without needing FDA approval, as long as the claims were truthful and not misleading. However, health claims (e.g., disease prevention or treatment) were subject to more stringent FDA regulation.

3. Safety Requirements: While dietary supplements were not required to undergo FDA approval before being marketed, the FDA could take action against products that were adulterated or misbranded, and manufacturers were required to report any adverse events associated with their products.

4. Good Manufacturing Practices (GMPs): DSHEA established that dietary supplement manufacturers must follow specific manufacturing standards to ensure product quality, safety, and consistency.

The DSHEA was pivotal in expanding the dietary supplement market while ensuring a level of oversight, though critics argue it has allowed for some questionable claims and practices in the industry.

1996 Health Insurance Portability and Accountability Act (HIPAA)

The 1996 Health Insurance Portability and Accountability Act (HIPAA) was a landmark U.S. law aimed at improving the efficiency and effectiveness of the healthcare system while ensuring the privacy and security of patient health information.

Key Provisions:

1. Privacy Rule: Established national standards for the protection of health information (protected health information, or PHI) to ensure that patients' personal health data is kept confidential and can only be shared with authorized individuals or entities.

2. Security Rule: Set standards for the security of electronic health information (ePHI), requiring healthcare organizations to implement safeguards to protect against data breaches and unauthorized access.

3. Portability: Ensured that individuals who changed or lost jobs would be able to maintain health insurance coverage, preventing the loss of coverage due to job transitions or pre-existing conditions.

4. Administrative Simplification: Introduced standards for electronic health transactions like claims processing, billing, and record-keeping, helping to reduce administrative costs and inefficiencies.

5. Enforcement and Penalties: Established the Office for Civil Rights (OCR) to enforce the law, with penalties for violations of privacy and security regulations.

HIPAA was a significant step in protecting patient rights, ensuring confidentiality of health information, and improving efficiency within the healthcare system.

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2003 Medicare Modernization Act

The 2003 Medicare Modernization Act (MMA) was a significant reform of the Medicare program, aimed at improving benefits for seniors and modernizing the program to meet evolving healthcare needs.

Key Provisions:

1. Medicare Part D: Introduced prescription drug coverage (Part D) for Medicare beneficiaries, providing subsidized prescription drug plans through private insurers. This was one of the most significant changes, aiming to help reduce the cost of medications for seniors.

2. Health Savings Accounts (HSAs): Established Health Savings Accounts, allowing individuals to save money in tax-free accounts for future medical expenses, paired with high-deductible health insurance plans.

3. Medicare Advantage (Part C): Expanded the Medicare Advantage program, allowing beneficiaries to receive their Medicare benefits through private insurance plans, which could offer additional benefits beyond traditional Medicare.

4. Improved Preventive Care: The act increased the focus on preventive health services, covering certain preventive screenings and services without cost-sharing.

5. Prescription Drug Discount Card: Introduced a prescription drug discount card to help seniors save on the cost of medications until the full Part D benefits were implemented.

The Medicare Modernization Act significantly expanded Medicare coverage, especially for prescription drugs, and aimed to make healthcare more affordable for seniors. However, it also raised concerns over long-term costs and the role of private insurers in the Medicare system.

2004 FDA Modernization Act

The 2004 FDA Modernization Act was a U.S. law that aimed to modernize and improve the operations of the Food and Drug Administration (FDA), with a focus on drug safety, medical device regulation, and the overall efficiency of the FDA's operations.

Key Provisions:

1. Clinical Trials: The act required the registration of clinical trials for drugs and medical devices, which increased transparency and allowed the public to access information about ongoing studies.

2. Fast Track for Drugs: Introduced provisions to accelerate the approval process for drugs that treat serious or life-threatening conditions, making them available to patients more quickly.

3. Pediatric Drug Testing: Encouraged testing of drugs in pediatric populations by providing incentives, such as market exclusivity extensions, to manufacturers who conducted studies on the safety and effectiveness of drugs for children.

4. Medical Device Regulation: Streamlined the approval process for medical devices, providing more flexibility and reducing delays in bringing devices to market while maintaining safety standards.

5. Drug Safety: Enhanced the FDA's ability to monitor the safety of drugs after they are on the market, including provisions for post-market surveillance and the ability to require black-box warnings or even withdrawal of unsafe drugs.

The FDA Modernization Act helped improve the speed and transparency of drug and medical device approval processes, while enhancing the FDA’s ability to protect public health and ensure the safety of products.

2005 Metamphetamine Epidemic Act

The 2005 Methamphetamine Epidemic Act was a U.S. law aimed at curbing the illegal production and distribution of methamphetamine, a highly addictive drug. It was part of the Combat Methamphetamine Epidemic Act and focused on regulating precursor chemicals used to manufacture meth.

Key Provisions:

1. Regulation of Pseudoephedrine and Ephedrine: The act restricted the sale of products containing pseudoephedrine and ephedrine (commonly found in cold medications), which are key ingredients in the production of methamphetamine. These products were placed behind the counter and could only be sold in limited quantities.

2. Tracking and Record-Keeping: Required retailers to track sales of products containing these ingredients, keeping detailed records of buyers, including their names, addresses, and the quantity purchased.

3. Purchase Limits: Set strict limits on the amount of pseudoephedrine or ephedrine an individual could purchase within a 30-day period.

4. New Reporting Requirements: Required pharmacies and sellers to report suspicious sales to the authorities and created a national database to track transactions.

The Methamphetamine Epidemic Act was intended to reduce the availability of methamphetamine by limiting access to precursor chemicals, and it has had a significant impact on efforts to combat meth production and abuse in the U.S.

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2006 (CMEA) Combat Methamphetamine Epidemic Act

The 2006 Combat Methamphetamine Epidemic Act (CMEA) was a key piece of legislation aimed at addressing the growing methamphetamine crisis in the United States by regulating the sale of substances commonly used to manufacture meth.

Key Provisions:

1. Regulated Pseudoephedrine Sales: Like the 2005 Methamphetamine Epidemic Act, the CMEA restricted the sale of products containing pseudoephedrine (found in many cold and allergy medications), making these products available only behind the pharmacy counter.

2. Purchase Limits: Established strict limits on the quantity of pseudoephedrine that a person could buy, both in a single transaction and within a 30-day period. This was designed to prevent individuals from buying large quantities for illegal use.

3. Identification and Record-Keeping: Buyers were required to show identification when purchasing products containing pseudoephedrine. Sellers had to keep detailed records of the transaction and report suspicious purchases to authorities.

4. National Tracking System: The act created a national tracking system to monitor sales of these chemicals, making it more difficult to “smurf” (i.e., have multiple people buy small amounts for illegal purposes).

5. Penalties: Imposed penalties for violations of the law, including the illegal sale or distribution of large quantities of pseudoephedrine for meth production.

The CMEA aimed to reduce the supply of methamphetamine by limiting access to the key ingredients used in its production, while still allowing legitimate access for consumers who need these medications for their intended use.