Pharmacy Law: Federal Amendments

Pure Food and Drug Act of 1906

Prohibited the misbranding and adulteration of food and drug products. Fell short because did not prevent false or misleading claims in the misbranding provisions of the law, and failed to regulate cosmetics or devices.

Food Drug and Cosmetic Act of 1938

Provided that no new drugs could be marketed until proven safe for use under the conditions described on the label and approved by the FDA. Expanded on the definitions of misbranding and adulteration, and required that labels must contain adequate directions for use and warnings about habit-forming properties of certain drugs. All drugs marketed before 1938 were exempt

Durham-Humphrey Amendment of 1951

Amendment that established two classes of drugs "prescription (legend), and non-prescription" drugs. In addition this amendment also authorized oral prescriptions and refills of legend drugs

Food Additive Amendment of 1958 (Delaney Clause)

Required that components added to food products receive pre-marketing approval for safety. This law also contains the Delaney cause which prohibits the approval of any food additive that has cancer causing potential

Color Additive Amendment of 1960

This law required manufacturers to establish the safety of color-additives in foods, drugs, and cosmetics. Under this law the FDA can approve a color for one use, but not others. This law also contained a Delaney cause

Kefauver-Harris Amendment of 1962 (also called the Drug Efficacy Amendment)

Strengthened the new drug approval process by required that drugs needed to prove safety and efficacy (this included drugs marketed before from 1938-1962). Also:

-Transferred jurisdiction of prescription drug advertising from the federal trade commission (FTC) to the FDA

- Established GMP requirements

-Added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of ADRs

Medical Device Amendments of 1976

Required more extensive regulation and administration authority regarding the safety and efficacy of medical devices. The MDAs requires:

-Classification of devices according to their function

-Premarket approval

-Establishment of performance standards

-Conformance with GMP regulations

-Adherence to record and reporting requirements

Orphan Drug Act of 1983

Provided tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologics for the treatments of "rare diseases or conditions"

Orphan Drug Modernization Plan on June 19, 2017

The passing of the Orphan Drug Act did lead to a backlog of request at the FDA, thus what did the FDA launch to combat this?

Prescription Drug Marketing Act of 1987

In response to the growing alarm that a secondary or diversionary distribution system for prescription drugs was threatening the public health and creating an unfair form of competition. Established sales restrictions and record-keeping requirements for prescription drug samples. Also prohibited hospitals and other healthcare entities from reselling pharmaceutical products to other business w/o proper licensing.

Safe Medical Devices Act of 1960

Gave the FDA additional authority in post-marketing requirements and premarket notifications and approval, while expediting the premarket device approval process.

The Generic Drug Enforcement Act of 1992

Authorized the FDA to ban individuals or firms from participating in the drug approval process if convicted or felonies involving bribery, etc. The law also imposes severe civil penalties for any false statements, bribes, failure to disclose material facts, and other related offenses.

Nutrition Labeling and Education Act of 1990

Mandated nutrition labeling on food products and authorizes health claims on product labeling, as long as they are in compliance with the FDA

Dietary Supplement Health and Education Act of 1994

Established the DSHEA to define dietary supplements and permit manufacturers to make certain claims that would have illegal under the FDCA. Forced the FDA to regulate supplements more as food than drugs.

Food and Drug Administration Modernization Act of 1997

Passed to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices. Also expanded the FDA's authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients. Also affected the regulation of medical devices in part by mandating priority review for break-through technologies in medical devices and allowing the FDA to contract with outside scientific experts for review of medical device applications

Drug Quality and Security Act of 2013 (Compounding Quality Act) Title I

Clarifies and strengthens FDA oversight over pharmacies engaged in the large-scale compounding and shipping of sterile products to other licensed entities. This law also removed uncertainty regarding when a product compounded by a pharmacy that is exempt from the CGMP, labeling, and new drug approval.

Drug Quality and Security Act of 2013 (Drug Supply Chain Security Act) Title II

Added "track and trace" requirements for all entities in the chain of distribution of pharmaceutical products. Manufacturers must provide transaction information to purchasers, who in turn must provide transaction information to subsequent purchases (wholesaler, pharmacies, etc). This law also mandated an electronic, interoperable product tracing system which strengthens wholesale and third-party logistics licensure requirements and requires manufacturers to serialize drugs

Prevention Packaging Act of 1970

Enacted to prevent young children <5 y/o from accidental poisoning by creating special packaging requirements. It is enforced by the consumer product safety commission (CPSC), and includes RX and OTC drugs

Combat Methamphetamine Epidemic Act of 2005

• Enacted to regulate the OTC sales of pseudoephedrine.

• Identity and address of each purchaser to be kept for two years.

• Daily sales of regulated products not to exceed 3.6 grams.

• 30 day purchase limit not to exceed 9 grams

• 30 day purchase via mail order not to exceed 7.5 grams

OBRA (1990 Omnibus Budget Reconciliation Act)

Mandated States to improve understanding of medications by medicaid beneficiaries

Included:

-Prospective and Retrospective Drug Review

-Educational Outreach programs

-Assessment of drug use data

-Patient counseling standards

-Requirement of maintaining patient records

Federal Hazardous Substances Act of 1966

Enforced by the CPSC, is intended to protect consumers from hazardous and toxic substances. Requires the label on the immediate package of a hazardous product and any outer wrapping or container that might cover up the label.