Drug Shortages
Myth: Drug shortages are primarily due to increased demand, so there’s nothing that can be done until manufacturing catches up.
Fact: While demand can contribute, drug shortages are often caused by manufacturing disruptions, quality control issues, supply chain problems, or regulatory delays. During such shortages, compounding pharmacies may step in to produce essential copies of medications using active pharmaceutical ingredients (APIs) to help bridge the gap. Compounding pharmacies play a crucial role in addressing drug shortages, especially when patients rely on life-saving or critical medications. By producing essential copies using APIs during shortages, they provide timely access to treatments that might otherwise be unavailable.
Myth: Compounding pharmacies cannot create essential copies of commercially available drugs.
Fact: Under normal circumstances, compounding pharmacies cannot produce exact copies of commercially available drugs. However, when a drug is on the FDA’s official Drug Shortage List, compounding pharmacies can legally create essential copies using APIs to ensure patients have access to life-saving and critical medications. By producing essential copies using APIs during shortages, compounding pharmacies they provide timely access to treatments that might otherwise be unavailable.
Myth: Once a drug is back in stock, pharmacies can continue producing compounded essential copies indefinitely.
Fact: Compounding pharmacies are only allowed to create essential copies while the drug remains on the FDA’s Drug Shortage List. Once the shortage is resolved, pharmacies must stop producing exact copies and must return to the usual approach of compounding commercially available drugs.
Myth: Compounded essential copies made during drug shortages are less effective than the original drugs.
Fact: When compounded under Good Manufacturing Practices (GMPs), essential copies made from APIs are formulated to be as effective and safe as the original drug. Compounding pharmacists use strict quality control measures and follow guidelines to ensure consistency, potency, and purity.