Many prescription drugs are currently in short supply.
Here are links to drug shortage lists:
Causes of drug shortages include FDA Warning Letters or Import Alerts and bans of foreign pharmaceutical company drugs and drug components. Here are links to FDA action lists:
Adulterated drugs and the FDA:
In the most basic sense, an adulterated drug is a drug that is inferior and, for one or more reasons, does not meet quality standards. The FDA can deem a drug “adulterated’ in an inspection report or now, if a foreign or domestic pharmaceutical company, compounding pharmacy or outsourcer refuses to allow the agency to inspect.
The FDA currently considers most adulterated drugs safe, and with limited exception, the agency does not have recall authority.Voluntary recall authority lies with pharmaceutical manufacturers, compounding pharmacies and outsourcers, and distributors and is often based on FDA safety concerns.
When a pharmaceutical company, compounding pharmacy or outsourcer fails to adequately respond to an FDA inspection request or inspection report, the agency can follow up by issuing an FDA Warning Letter and/or Import Alert and ban of a foreign pharmaceutical company’s drugs or drug components. This can cause manufacturing and distribution disruptions that lead to drug shortages. In some cases, when the costs of producing and distributing them increase, drugs become less profitable and the pharmaceutical company discontinues the medicine. So, product discontinuation is another reason for drug shortages. In some instances, when demand remains constant and supplies diminish, it can trigger stockpiling and in extreme cases, drug diversion.
Medication Access During a Drug Shortage:
Some medications that are in short supply can be custom compounded by specialty pharmacies. Although in many cases, these medicines are not covered and there may be additional charges such as express shipping and refrigeration, in some cases.
Finding a Compounding Pharmacy:
The Pharmacy Compounding Accreditation Board (PCAB) established a voluntary quality accreditation designation for compounding pharmacies. PCAB’s website has contact information and a free online compounding pharmacy locator.
The International Academy of Compounding Pharmacists (IACP) website also offers a free online compounding pharmacy locator.
Reporting a Drug Shortage:
Reporting Drug Safety Issues:
To report drug safety issue such as an adverse reaction, patients and health care providers can contact the pharmaceutical company, their state board of pharmacy, or file a report online at FDA’s MedWatch
Patients should contact their doctor and pharmacy. The information should be added to their medical records, and pharmacy profile.