Pharmacy Law

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Pure Food and Drug Act

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1906, prohibited the interstate distribution or sale of adulterated or misbranded food or drugs. First federal law regulating drugs. Later replaced by Food, Drug, and Cosmetic Act

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Food, Drug and Cosmetic Act (FD&C Act)

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1938, requires all drug manufacturers to file a New Drug Application (NDA) with the FDA before any drug could be approved or disapproved for the market. Manufacturers must ensure purity, safety, packaging and strength of the medication. Basis for today's pharmacy laws and requires medications to be labeled with adequate directions for safe use.

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Durham-Humphrey Amendment

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1951, enacted to prohibit dispensing legend drugs without prescription. This was to end prescription drugs accidentally being sold over the counter. Also allowed verbal prescriptions to be taken over the phone and allowed refills to be called in from a physicians office.

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Kefauver-Harris Amendment

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1963, required that all medication, prescription or otherwise, be pure effective and safe to use on humans. Placed prescription drug advertisements, along with qualifications for drug investigators, under supervision of FDA. Required manufacturers to register and allow inspection of their manufacturing sites.

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Schedule I (CI)

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Drugs having no accepted medical use in the United States. High abuse potential

Hint 5

LSD, crack, mescsline, heroine, marijuana

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Controlled Substances Act aka Comprehensive Drug Abuse Prevention and Control Act

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1970, requires pharmaceutical industry to keep records and maintain security measures for certain medications. DEA related anything related to controlled drugs.

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Schedule II (CII)

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Drugs having an accepted medical use and a high abuse potential, with severe psychological or physical dependence liability.

Hint 7

Amphetamines (Ritalin, Concerta, Adderall), Percocet, physiological or physical fentanyl (Duragesic), methadone

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Schedule III (CIII)

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Drugs having an acceptable medical use and an abuse potential less than those of Schedule I and Schedule II

Hint 8

Combination narcotics such as Tylenol 3

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Schedule IV (CIV)

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Drugs that have an accepted medical use and an abuse potential less than those listed in schedule III.

Hint 9

Benzodiazepines such as lorazepam and alprazolam, as well as hypnotics such as zolpidem or Ambien

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Schedule V (CV)

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Drugs having an accepted medical use and an abuse potential less than those listed in schedule IV

Hint 10

Lomotil or cough preps with codeine, such as Robitussin AC

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Form 222

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Deals with ordering of schedule II drugs. Not needed for any other drugs. All schedule drugs marked with a big red C and labeled with proper schedule.

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Form 41

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Submitted to DEA for destruction if outdated or damaged controlled substances.

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Form 106

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Submitted to DEA after discovery of a theft of controlled substances.

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Poison Prevention Packaging Act

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1970, created standards for child-resistant packaging. Mandates that packaging be very difficult to open by young children.

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Occupational Safety and Health Act

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1970, established the Occupational Safety and Health Administration (OSHA). Established to prevent workplace disease and injuries. Requires employers to provide safe work environments. Also introduced Material Safety Data Sheets (MSDS).

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Material Safety Data Sheets (MSDS)

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Forms completed by compound manufacturers that provides information about a chemical in detail.

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Drug Listing Act

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1972, assigns a unique and permanent drug code to each medication, also known as the National Drug Code (NDC). It identifies the manufacturer, medication and size or type of the packaging. It's an 11 digit code: First five indicates manufacturer. The next four indicates the drug product and the last two indicates the package size.

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Federal Hazardous Substance Act (FHSA)

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1960, involves the use and disposal of hazardous material in the pharmacy. Mainly in the hospital setting, or more specifically, the IV room where intravenous solutions are being prepared. Abby drug involving human blood or cancer should be disposed in containers marked for hazardous substances, this includes any PPE as well.

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Orphan Drug Act

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1983, offers financial incentives to organizations that develop and market orphan drugs. These are medications that are used for the treatment of a disease or condition that affects 200,000 or fewer patients. Meds that treat small populations are often not cost effective so they are offers tax incentives and a monopoly on the patent for seven years.

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Drug Price Competition and Patent Term Restoration Act

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1984, encouraged the creation of new medications by extending patent licenses. Also helped with the increasing costs of drug prices by streamlining the generic drug approval process.

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Prescription Drug Marketing Act

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1987, prohibits the sale or distribution of samples to anyone other than those who are licensed to prescribe them. It also prohibits the reimportation of a drug into the US by anyone except the manufacturer.

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Omnibus Budget Reconciliation Act (OBRA)

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1990, contains important amendments that effect both Medicare and Medicaid. Act requires pharmacies that fill prescription order for Medicaid patients to obtain, record, and maintain basic patient information. Also requires its pharmacists to offer counseling to patients and perform drug utilization reviews, which are used to make sure medications dispensed in past were correct.

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Anabolic Steroids Control Act

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1990, allows the Controlled Substances Act (CSA) to regulate anabolic steroids. Under this act anabolic steroids became a schedule III controlled substance. Also raises penalties for illegal distribution of these agents.

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Health Insurance Portability and Accountability Act (HIPAA)

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1996, implemented to improve continuity and portability of health insurance for patients. Improved Medicare and Medicaid by implementing systems to share and store private health information. Regulations are divided into three parts: privacy regulations, security regulations, and transaction standards.

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FDA Modernization Act

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1997, designed to reform the regulation of cosmetics, food, and medical products. Its main focus is safe pharmacy compounding and the regulation of medical devices. Law also requires the labels of every legend medication to bear the words 'Rx only'. Overall improved FDA's regulation of medications, with focus on speeding up approval process.

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Medicare Prescription Drug Improvement and Modernization Act of 2003

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2003, aka Medicare Modernization Act (MMA). Provided voluntary prescription drug benefits to patients eligible for Medicare.

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Combat Methamphetamine Epidemic Act

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2005, intended to stop the use of the illegal drug methamphetamine. Required drugs used to manufacture meth to be locked up behind counter. Also limits the amount one person can buy at a time and in a month. Anyone buying these drugs must show ID and register with the pharmacy.

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State Boards of Pharmacy

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Each state had its own board of pharmacy (BOP). These boards are designed to establish state specific pharmacy laws and regulations. Also responsible for licensure and certification of pharmacy staff.

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Drug Enforcement Agency

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Aka the DEA is a federal regulatory body that is responsible for enforcing controlled substance legislation. Their focus is on major violators of the controlled substance act who use violence as part of their illegal transactions.

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Food and Drug Administration

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Aka FDA, enforces the safety and effectiveness of foods, medications, biological products, cosmetics, and radioactive substances. It disseminates information about the products it regulates with an emphasis on better, safer and more cost effective products.

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The Joint Commission

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A body that accredits and certifies healthcare organizations in the United States. Independent and not for profit agency works to improve safety and quality of healthcare.

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United States Pharmacopeia Act (USP)

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Sets the standards for all prescriptions, OTC medications, and dietary supplements manufactured and sold in the US. The standards are related to quality, purity, strength and safety.

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USP-797 Act

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Sets standards for sterile compounding and is essential for protecting patients against infections that may be transmitted through pharmaceutical products.

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National Association if the Boards of Pharmacy (NABP)

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Assists the boards of pharmacy in each state to protect public health by developing uniform standards.