Key Takeaways
- The FDA regulates drug safety, approvals, labeling, and manufacturing under the FDCA (Food, Drug, and Cosmetic Act).
- Drug recalls have three classes: Class I (serious harm/death), Class II (temporary/reversible harm), Class III (unlikely to cause harm).
- Most recalls are voluntary by manufacturers; FDA can mandate recalls for devices but not drugs (uses seizure authority instead).
- OTC drugs must meet FDA monograph requirements or have an approved NDA (New Drug Application).
- FDA MedWatch program allows healthcare professionals and patients to report adverse events and safety concerns.
FDA Regulations and Drug Recalls
Quick Answer: The FDA regulates drug safety through the FDCA. Drug recalls are classified as Class I (serious harm/death risk), Class II (temporary harm), or Class III (unlikely harm). Most recalls are voluntary. Pharmacy technicians must know how to identify recalled products and remove them from inventory.
The Food and Drug Administration (FDA) regulates the safety, efficacy, and security of human drugs, biological products, and medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
FDA's Role in Pharmacy
| Function | Description |
|---|---|
| Drug Approval | Reviews NDAs (New Drug Applications) and ANDAs (Abbreviated NDAs for generics) |
| Manufacturing Oversight | Inspects facilities for Good Manufacturing Practices (GMP) compliance |
| Labeling Requirements | Establishes requirements for drug labels, package inserts, and advertising |
| Post-Market Surveillance | Monitors drug safety after approval through MedWatch and FAERS |
| Recall Coordination | Oversees and classifies drug recalls |
Drug Recall Classifications
When a drug is recalled, the FDA classifies it based on potential health hazard:
| Class | Health Hazard | Action Required | Examples |
|---|---|---|---|
| Class I | Reasonable probability of serious adverse health consequences or death | Immediate removal, urgent notification | Contamination with deadly bacteria, mislabeled potent drugs |
| Class II | May cause temporary or medically reversible adverse health consequences | Prompt removal, customer notification | Incorrect potency, missing information on label |
| Class III | Not likely to cause adverse health consequences | Removal at next inventory check | Minor labeling errors, aesthetic defects |
Types of Recalls
| Recall Type | Description |
|---|---|
| Voluntary Recall | Manufacturer initiates recall (most common) |
| FDA-Requested Recall | FDA requests manufacturer action |
| FDA Mandate | FDA can mandate recalls for medical devices, but not drugs |
| Market Withdrawal | Minor issue not related to FDA violation |
| Stock Recovery | Product hasn't left manufacturer control |
Key Point: While FDA cannot legally mandate drug recalls, it can seek court-ordered seizure of adulterated or misbranded drugs. In practice, manufacturers almost always comply with FDA recall requests.
Pharmacy Responsibilities During Recalls
- Monitor recall notices — Check FDA website, wholesaler communications, manufacturer alerts
- Identify affected products — Check lot numbers, expiration dates, NDCs against recall list
- Quarantine recalled products — Segregate from dispensable inventory immediately
- Notify patients (for Class I recalls) — Contact patients who received recalled medication
- Return products — Follow manufacturer/wholesaler instructions for return
- Document actions — Maintain records of recall response
FDA MedWatch Program
MedWatch is the FDA's safety reporting program for:
- Adverse events from drugs, biologics, and medical devices
- Product quality problems (contamination, labeling issues)
- Medication errors
- Product use errors
Who Can Report?
- Healthcare professionals (pharmacists, technicians, nurses, physicians)
- Patients and consumers
- Manufacturers (mandatory reporting requirements)
How to Report
- Online at FDA.gov/MedWatch
- By phone: 1-800-FDA-1088
- By mail: FDA Form 3500 (voluntary) or 3500A (mandatory)
Drug Labeling Requirements
Prescription Drug Labels Must Include:
- Drug name (brand and generic)
- Dosage form and strength
- Route of administration
- Quantity
- Manufacturer information
- Lot number and expiration date
- NDC number
- Storage requirements
- Rx only symbol
OTC Drug Labels ("Drug Facts"):
- Active ingredient(s) and purpose
- Uses (indications)
- Warnings
- Directions
- Other information (storage)
- Inactive ingredients
FDA Orange Book
The Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) lists:
- All approved prescription drugs
- Therapeutic equivalence ratings (e.g., AB-rated generics)
- Patent and exclusivity information
| Rating | Meaning |
|---|---|
| A-rated | Therapeutically equivalent (can substitute) |
| AB | Meets bioequivalence requirements |
| B-rated | NOT therapeutically equivalent (cannot automatically substitute) |
A manufacturer discovers that a batch of blood pressure medication contains a carcinogenic impurity that could cause cancer with long-term use. What FDA recall class would this most likely be?
Which FDA program allows pharmacy technicians and other healthcare professionals to voluntarily report adverse drug events and product quality problems?
When checking if a generic drug can be substituted for a brand-name drug, pharmacy technicians may reference the FDA Orange Book. What rating indicates a generic is therapeutically equivalent and can be substituted?