Federal Law and Regulations of Medication Prohibited Acts

Food and Drug Administration (FDA) Functions

• Rulemaking

• Issue guidance documents

• Incorporate advice from standing advisory committees of outside experts

• Inspections/Investigations

Rationale for Federal Drug Regulation: Protect the public from adulterated and misbranded drug products

Drug Recall

A method of removing misbranded and/or adulterated products from the market to protect the public

• Voluntarily by manufacturer

• FDA request

• Mandated by the FDA

  • FDA limited authority to recall certain products such as medical devices, biological products, and foods BUT NOT DRUGS

Classifications of Recalls: 3 classes based on level of risk

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* Seizure or injunction action if FDA request for recall is ignored

*FDA possesses mandatory recall authority only with regard to four products: infant formula, medical devices, biologic products, and tobacco products 

Classification of Recalls

• Class I: Reasonable probability that product will cause serious adverse health effects or death 

• Class II: Product may cause temporary or medically reversible adverse health effects, but serious adverse effects are remote 

• Class III: Product unlikely to cause adverse health effects

Federal Law

Prohibited Acts, Penalties and Enforcement

• FDA enforces violations of FD&C Act

• Violations basically relate to:

  • Adulteration

  • Misbranding

  • Tampering

  • Counterfeit Drugs

Adulteration

Adulteration is defined as containing poisonous, insanitary ingredients or manufactured without adequate controls 

• Filthy, putrid, or decomposed product 

• Prepared, packaged, or stored under insanitary conditions that do not comply with CGMP

• Containing a color additive that is unsafe

• Strength, quality, or purity different from the official compendium 

• Mixed with or ingredient s substituted with another substance 

• Package can contaminate the product 

Can Cosmetics be Adulterated?

Cosmetics can be adulterated if:

• It contains any poisonous or deleterious substances that may injure users

• It contains filthy, putrid, or decomposed substance

• It is prepared under unsanitary conditions

• The container contains a substance that may contaminate the contents

• It contains unsafe color additives but not a hair dye containing coal tar

Hair dyes that contain coal tar are exempt from adulteration and color additive provisions of the law

Misbranded Drugs

The FDA approves the exact wording of the label and labeling during the pre-market approval process

Misbranding focuses on the representation made by the manufacturer on the label or labeling

A drug is misbranded if:

• The label or labeling is false or misleading

• The label or labeling does not include required elements

• The required label or labeling is not prominently displayed

• It is an imitation of another drug (i.e., same shape, size, color, similar or almost identical in gross appearance, similar in effect to controlled substances)

• Its packaging does not conform to poison prevention packaging act 1970

Can cosmetics be misbranded?

The ingredients must be listed in descending order of predominance. However there are a few exceptions to this requirement.

Exceptions

• Active drug ingredients

• Ingredients with less than 1% concentration

• Color additives 

• “And other ingredients” 

Federal Anti-Tampering Act Tampering with Consumer Products

Federal offense to tamper with consumer products

Tampering is defined as: Improper interference with the product for the purpose of making objectionable or unauthorized changes

• FDA regulations require that certain OTC human drugs, cosmetics, and devices be manufactured in tamper-resistant packaging

• Tamper-resistant packaging provides visible evidence to a consumer that tampering occurred