2.3 - Adulteration & Misbranding; Labeling, Product Recalls, Pregnancy Warning, & Black-box Warning

FDA Enforcement of FDCA

1. §302 Injunctive action against the violator to cause it to cease its illegal activity.

2. §303 FDA can institute criminal proceedings against violators resulting in fines, imprisonment or both

3. §304 Allows the FDA to seize any adulterated or misbranded food, drug, or cosmetic in interstate commerce

4. §309 Allows the FDA to send a warning letter to the violator as a first step when such an action would adequately serve the public. (MINOR VIOLATIONS)

Product Recalls

- FDA has LIMITED authority to recall certain products and NO authority for recalling drugs

- manufacturers are responsible for notifying consumers

- Require that written notes for Class I,II, and some III recalls be sent by first-class mail with envelope/letterhead marked in red, URGENT: DRUG RECALL

Drug Recall

voluntary action taken by a company to remove a defective drug product from the market

FDA’s role in drug recall

- oversee a company’s strategy

- assess the adequacy of the recall

- classify the recall

- alerting the public

Class I Drug Recall

issued when reasonable probability that the product will cause serious ADRs or consequences

Class II Drug Recalls

may cause temporary/reversible ADRs; probability of serious ADR is remote

Class III Drug Recalls

apply to products that are NOT likely to cause ADRs

adulteration

the product itself is contaminated or tainted in some way, usually during manufacturing, storage, or packaging

misbranding

label on a product is wrong, misleading, or missing important information

Current Good Manufacturing Practices

a set of regulations that establishes minimum requirements for methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product (inspected for compliance every 2 years)

OTC Tylenol incident

- contamination of OTC Tylenol with cyanide

- resulted in use of tamper-resistant or tamper-evident packaging

- Federal Anti-tampering act

Nonprescription drug labeling requirements

- name & address of manufacturer, packer, distributor

- expiration date, lot or batch number, principal display panel

- established name of drug, pharmacological category or principle intended action, quantity, tamper evident labeling, cautions and warnings, adequate directions for use, Warnings

- inactive ingredients are listed in alphabetical order, questions and phone number

Adequate Directions of Use

quantity/dosage + frequency + duration + route + preparation (if necessary)

Prescription Drug Labeling

must include:

• Drug’s indications

• Side effects

• Dosages

• Routes, methods, frequency, and duration of administration

• Contraindications

• Other warnings and precautions that enable a practitioner to administer, prescribe, or dispense the drug safely

Imitation Drugs

- Identical in shape, size, and color

- Similar or virtually identical in gross appearance

- Similar in effect to controlled

substances

Official Compendia-United States Pharmacopeia

- USP-NF or HPUS

- a drug is recognized in the USP or the HPUS the drug product must meet all standards of the compendia or it can be considered misbranded or adulterated

Box Warnings

Highest safety-related warning that medications can have assigned by the FDA. Intended to bring consumer’s attention to major risks of the drug.

Risk Evaluation and Mitigation Strategy (REMS)

- Drug Safety program FDA requires for certain drugs to ensure benefits outweigh

risks

- Reinforce medication use behaviors and actions that support safe use of medication

National Drug Code (NDC) Number

- 10 digit 3 segment code

- Labeler Code + Product Code + Package Code

- proposed change in 2022, to be 12 digits (6-4-2)