Pharmacy Law Lecture 3

Objectives

• Know the definitions for adulteration and misbranding and when each apply.

• Understand the historical context and motivations behind the enactment of the Food, Drug, and Cosmetic Act of 1938 and all of its amendments including Durham-Humphrey, Kefauver-Harris, Orphan Drug Act, Drug Price Competition and Patent Term Restoration Act, Drug Quality and Security Act, Compounding Quality Act, 21st Century Cures Act, and the Food and Drug Omnibus Reform Act. 

• Evaluate the impact of the FDA on various aspects of pharmacy practice, including drug safety, pharmaceutical packaging, compounding, and drug supply chain. 

• Describe the elements required on a prescription label, labeling, OTC labeling, and physician prescribing information. Know the difference between these many forms of labels. 

• Understand which products the FDA regulates and which it does not (food, drug, vitamins, medical foods…

The FDA is part of what larger government agency?

Department of Health and Human Services

Food and Drugs Act of 1906 (and definitions)

Banned interstate and foreign commerce of adulterated and misbranded food and drugs. Brought on by public outrage at Upton Sinclair’s “Jungle”.

Adulterated if…

1. Filthy, putrid, or decomposed substance.

2. Prepared, packed, or held under unsanitary conditions.

3. Drug’s strength, quality, or purity differs from those stated on the label.

Misbranded if…

1. False or misleading label.

2. Label is missing required information.

3. If it looks too much like another drug (imitation).

Something can be both adulterated and misbranded.

Federal Food, Drug and Cosmetic Act (FDC) of 1938

Spurred on by the 1937 Sulfanilamide Tragedy, required drugs to prove safety before being marketed.

What does the FDA regulate? What does it not regulate?

• Foods

• Drugs

• Biologics (vaccines, gene therapies, etc.)

• Medical Devices

• Electronic Products (Radiation-emitting)

• Cosmetics

• Veterinary Products

It doesn’t regulate vitamins or supplements.

Definition of Drug from the FDA (section 201g of the Food, Drug and Cosmetics Act)

1. Any susbtance in the United States Pharmacopoeia (USP), Homeopathic Pharmacopoeia, or any other Official National Formulary

2. Substances “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals".”

3. Substances other than food intended to affect the structure or function of the body of man or other animals.

Definition of Food from the Food Drug and Cosmetic Act (FDCA)

1. Substances used for food or drink for man or other animals.

2. Chewing gum

3. Substances used for components of any such substance.

Durham-Humphrey Amendment of 1951

Creates the requirement for certain drugs to be obtained as prescriptions.

Kefauver-Harris Drug Amendment of 1962

Drugs must be proven effective as well as safe. Spurred on by the Thalidomide babies of the early 1960s.

What is required on a prescription label?

• Pharmacy name/address/phone #

• Dr.’s name

• Date prescription filled

• Do not use date

• # of refills

• Total # of pills

• Name of drug and strength of drug

• Dosing instructions

• Person who gets the drug

• Number used to ID the drug for refills

• Physical description of drug

Also: warning labels (if applicable)

Drug Label vs. Labeling

Label: Label on bottle.

Labeling: All other information including black box warnings, directions, side effects, etc. (pamphlet)

FDA Tamper-Resistant Packaging Guidance

Required most OTC drugs to be packaged in tamper-resistant packaging. Spurred on by cyanide being found in Tylenol bottles in 1980. Guidance was made in 1982 and took effect 1983.

Orphan Drug Act of 1983 (and definition)

Created financial incentives for industry to create medicine for rare diseases.

Orphan Drug: For treatment of a disease effecting less than 200,000 people in the US or not expected to be profitable for 7 years after approval. Grants 25% tax credit for clinical trial costs, waiver of FDA fees, market exclusivity, and federal grants.

Therapeutic Equivalence

AA/AB: No bioequivalence problems in normal dosage forms or confirmed through studies.

A(X): X denotes specific dosage type for bioequivalence.

B(X): Various levels of concern or lack of data regarding bioequivalence.

Drug vs. Food

Special Dietary Food: Supplies a special dietary need otherwise not in a normal diet (baby formula, high-calorie shakes). Not a drug and can make health claims.

Medical Food: Specific dietary management of a disease or condition under supervision of a physician. Not a drug and can make health claims.

Differs from normal food items which can’t make health claims.

Dietary Supplements (definition and FDA oversight)

Product intended for ingestion, to supplement diet and contains one or more of the following:

• Vitamin

• Mineral

• Herb

• AA

• Supplement that increases dietary intake

FDA cannot require pre-market approval for safety or efficacy, but can go after companies that don’t follow GMPs.

What to do as a pharmacist regarding dietary supplements:

Steer customers to products with a USP/NF symbol. Provide info when appropriate. Do not promote supplements based on unapproved claims. Provide informational materials if you can give the entire publication with it.

Drug Facts on OTC Label Requirements

• Active/Inactive Ingredients

• Uses

• Warnings

• Stop use and ask a doctor if…/keep out of reach of children…

• Directions

• Other Information

Food and Drug Administration Amendments Act (REMS) (2007)

Created REMS (Risk Evaluation and Mitigation Strategy) requirements for certain medications.

Family Smoking Prevention and Tobacco Control Act (2009)

Prohibited flavoring cigarette products that could feasibly be advertised to children.

Affordable Care Act created what other act pertinent to this course?

The Biologics Price Competition and Innovation Act, which created the Purple Book for similarity between biologics.