Legal Issues in Self-Care Pharmacy Practice

The idea that individuals can take responsibility for their own health and well-being, using non-prescription medications to treat minor ailments.

Products sold directly to consumers without a prescription, often used for self-treatment of minor health issues.

The U.S. Food and Drug Administration is responsible for regulating the safety and efficacy of nonprescription drugs, ensuring they are safe for public use.

The Federal Trade Commission's role is to prevent unfair or deceptive advertising practices, including those related to nonprescription drug products.

The historical era of unregulated medicines, often containing dubious ingredients and making exaggerated claims of benefits.

The 1906 Pure Food and Drugs Act helped regulate the sale of medications by prohibiting adulteration and misbranding, which forced many questionable products off the market.

The Harrison Narcotic Act of 1914 made opium and other narcotics prescription-only, helping to control their use and prevent misuse.

Pharmacists are expected to stay informed about legal and regulatory changes related to nonprescription medications to provide accurate information to patients and uphold professional standards.

Establishes a requirement for OTC manufacturers and contract manufacturers to pay user fees for Tier 1 and Tier 2 activities.

Describes FDA's risk-based approach for enforcement and regulatory actions based on 6 different categories.

Describes the electronic drug registration and listing system and introduces new portals for OTC Monograph submissions.

Adds phosphorus to the list of ingredients that must be disclosed on the label if the content is greater than 5 milligrams per dosage unit.

Clarifies the statement of identity required for labeling and outlines circumstances where the FDA might exercise enforcement discretion.

Identifies best practices for naming nonprescription products, including those switched from prescription status.

Describes the need for maximal usage trials to support an FDA determination that a topically applied product for OTC use is GRASE (Generally Recognized as Safe and Effective).

A type of drug switch where a formerly prescription-only drug is only available over-the-counter (OTC).

This document outlines the FDA's regulatory framework and guidelines for over-the-counter (OTC) drug products including homeopathic products and user fees.

A type of drug switch where only some indications for a drug are made available OTC, while others remain prescription-only.

A medication that is available over-the-counter without a prescription from a doctor. It may be a formerly prescription-only drug that underwent a switch.

A medication that requires a prescription from a doctor to be obtained.

A process that involves switching a prescription drug to over-the-counter (OTC) availability. This involves a review and approval by the FDA.

A drug that is available in both prescription and over-the-counter (OTC) versions, but with different dosages or indications for each.

A study to ensure the labeling of an OTC drug is clear and understandable for consumers.

Clinical trials that evaluate the safety and effectiveness of a drug for its intended use, specifically for over-the-counter (OTC) status.

A proposed classification of drugs that can be purchased without a prescription, with additional controls like counseling or technology-based assessments.

The US Food and Drug Administration's initiative aimed at expanding the availability of nonprescription drugs, while ensuring their safe and effective use.

A technological solution used in pharmacies to help patients understand and decide on nonprescription medications.

The potential conflict between the FDA's proposed rule on third class drugs and state laws regarding the sale of medications via kiosks.

The question of whether third class drugs should be accessible in all locations, or limited to pharmacies with pharmacists present.

The uncertainty surrounding the availability of third class drugs, whether they should be fully OTC or sold behind the counter like some prescription medications.

Questions regarding the impact of the proposed rule on the pharmacy profession, including the potential for a new category of drugs.

The possibility that the proposed rule could significantly change the volume of prescriptions being filled as more medications become available over-the-counter.

When a prescription drug becomes available over-the-counter (OTC), it often gets a new name to distinguish it from its prescription form.

If a nonprescription medication changes its active ingredients, a special warning must be displayed on the label informing consumers.

Some nonprescription drug monographs have additional information specifically for healthcare professionals, not included in the consumer labeling.

Nonprescription drug labels are required to list the sodium and potassium content, except when the combined amount is less than 5 milligrams.

FDA guidance clarifies sodium, potassium and phosphorus labeling requirements based on the dosage of nonprescription drugs.

Packaging of nonprescription drugs is regulated by FDA. Tamper-resistant packaging is mandatory for most oral, nasal, otic, ophthalmic, rectal, and vaginal medications.

Tamper-resistant packaging is designed to prevent access to the product. It aims to ensure the product hasn't been tampered with.

The Federal Anti-Tampering Act of 1982 mandated tamper-resistant packaging for certain nonprescription medications to prevent product tampering.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines dietary supplements and sets regulatory guidelines for them.

Dietary supplements in the U.S. are not approved by the FDA for safety and efficacy. However, they are subject to regulations regarding adulteration and misbranding.

The DSHEA requires pre-market notification for any new dietary ingredients (NDIs), but doesn't require evaluation for safety or efficacy.

FDA's enforcement of DSHEA regulations has been challenging. While thousands of new supplements enter the market, only a limited number of pre-market notifications are submitted.

The FDA recently established a Dietary Supplement Ingredient Advisory List to quickly alert the public about ingredients that may be illegally marketed in supplements.

FDA strengthened dietary supplement regulation by implementing new 75-day pre-market notification requirements for NDIs and the Dietary Supplement Ingredient Advisory List.

Under the DSHEA, labels for dietary supplements must clearly state "dietary supplement" and list the quantity of each ingredient.

FDA has determined that products containing THC and CBD are not considered dietary supplements under the DSHEA.