US drug shortages remain stubborn, with 227 active shortages in the second quarter of 2026, according to ASHP and University of Utah data. When a drug is on FDA’s shortage list, federal law lets a 503A compounding pharmacy prepare it for an individual patient with a valid prescription. Once the shortage ends, routine copies are restricted again, as the GLP-1 story showed. Compounded medications are not FDA-approved, so speak with your prescriber first.
The United States had 227 active drug shortages in the second quarter of 2026, the third straight quarterly increase, according to data from the American Society of Health-System Pharmacists (ASHP) and the University of Utah Drug Information Service reported by AJMC. For many patients, a compounding pharmacy is one of the few options when a pharmacy shelf is empty. That is down from the all-time high of 323 in the first quarter of 2024, but the trend is rising again.
Behind each shortage are patients who heard “it’s on backorder” and now wonder whether a compounded version is possible, legal, and safe.
This article explains why shortages happen, what federal law lets a 503A compounding pharmacy do (and not do), and how to approach the conversation with your doctor. King’s Pharmacy and Compounding Center in Irvine is a state-licensed compounding pharmacy, and our pharmacists field these questions from patients and prescribers often.
Where US Drug Shortages Stand in 2026
Drug shortages have eased since their 2024 peak but are climbing again. ASHP and University of Utah data put active shortages at 227 in the second quarter of 2026, and 48% of new 2026 shortages involve sole-source products, meaning a single company supplies the drug.
Recent examples show how wide the impact can be. The same ASHP data reported by AJMC notes that ifosfamide, a chemotherapy agent used in several cancer regimens, entered a severe shortage after quality problems at a key supplier. Contrast agents used for CT and MRI scans made up 10% of new shortages in 2026.
Two Lists, Two Purposes
ASHP’s count and FDA’s shortage list are not the same thing, and the difference matters. FDA’s Drug Shortages Database focuses on medically necessary products and lists a drug as currently in shortage when the total supply of all clinically interchangeable versions is inadequate. ASHP publishes its shortage list along with suggested alternative therapies, and FDA itself points clinicians to ASHP for alternatives because recommending substitutes is part of the practice of medicine. For compounding, FDA’s list, not ASHP’s, is the one that changes the rules for a 503A pharmacy.
Why Drug Shortages Keep Happening
FDA’s report on the root causes of drug shortages, first published in 2019, remains the agency’s long-standing analysis. It found that manufacturers have little incentive to make low-profit drugs, many of them older generics. It also found that the market does not reward companies for mature quality systems and that logistical and regulatory hurdles make it slow to recover once something breaks.
Manufacturers are not always forthcoming about the cause. According to University of Utah data cited by AJMC, manufacturers reported an unknown reason or no reason for 59% of shortages in 2025. Supply and demand mismatches accounted for 16%, and manufacturing problems for 15%.
The result: a low-margin drug made at one plant can vanish from pharmacies nationwide after a single quality problem and take months to return.
What a 503A Compounding Pharmacy Is Allowed to Do
A 503A compounding pharmacy is a state-licensed pharmacy that prepares medications for individual patients based on a valid prescription. Federal law generally bars it from regularly making “essentially copies” of commercially available drugs. However, FDA treats a drug on its shortage list as not commercially available, which changes what a 503A pharmacy may prepare.
The name comes from Section 503A of the Federal Food, Drug, and Cosmetic Act. These pharmacies are primarily overseen by state boards of pharmacy.
The “Essentially a Copy” Limit
In plain terms, a compounded drug is “essentially a copy” when it closely matches an FDA-approved product that patients could otherwise buy. Under 503A, a pharmacy may not make such copies regularly or in inordinate amounts.
FDA has also described how it currently applies that limit. In an April 1, 2026 update, the agency stated that, at this time, it does not intend to take action against a 503A compounder for making an essentially copy product regularly or in inordinate amounts, provided the compounder fills four or fewer prescriptions of that compounded product during a calendar month. This is an FDA enforcement policy, not a change to the law itself.
The Shortage List Exception
When a drug is on the FDA’s shortage list, the copy limit does not apply to it. Every other 503A condition still applies, including the requirement that the medication be compounded for an identified individual patient based on a valid prescription. A shortage relaxes one rule; it does not turn a pharmacy into a manufacturer.
503A and 503B in Brief
Section 503B covers outsourcing facilities, a separate category that may compound larger batches without patient-specific prescriptions and operates under direct FDA oversight. FDA notes that 503B facilities may use bulk drug substances to make copies of shortage drugs, with a limited wind-down period after a drug leaves the list.
The GLP-1 Shortage: What Happened When It Ended
The clearest recent example of these rules in action involves the GLP-1 medications tirzepatide and semaglutide. Both drugs spent long stretches on the FDA’s shortage list, and compounded versions were lawful while the shortages lasted.
Then the shortages ended. According to FDA’s timeline, the agency confirmed on December 19, 2024, that the tirzepatide shortage was resolved, and the 503A enforcement period ended on March 5, 2025, after a court denied a request to block the FDA’s decision. The 503B period ended March 19, 2025. FDA declared the semaglutide shortage resolved on February 21, 2025, and the 503A period ended April 24, 2025, with the 503B period running until May 22, 2025.
FDA has continued to focus on how compounded GLP-1s are marketed. A June 15, 2026 FDA guidance update, reported by Becker’s Hospital Review, identified misleading practices such as calling a compounded drug a generic, claiming FDA approval, or saying a product comes from an “FDA-approved” facility.
The agency has also raised safety concerns. FDA’s page on unapproved GLP-1 drugs describes adverse events tied to dosing errors with compounded injectables, salt forms of semaglutide that it says have no lawful basis in compounding, and illegal online sellers. The lesson is simple: shortage-based compounding is a bridge, not a permanent substitute.
What a Compounding Pharmacy Can and Can’t Do During a Shortage
A compounding pharmacy may be able to prepare a shortage drug, or a clinically appropriate alternative form, for one patient when the ingredients are available and the pharmacy has the right equipment and expertise. It cannot mass-produce a drug, guarantee access to every shortage medication, or offer an FDA-approved product.
Compounders face supply limits too. They depend on access to quality active ingredients, and the FDA notes that some shortage drugs cannot be compounded because a pharmacy lacks the expertise or equipment or has business reasons not to make them. FDA also recommends that prescribers choose an FDA-approved drug when one is available and appropriate.
Outside of shortages, compounding has a long-standing role for patients with documented needs, such as a dye-free or allergen-free version or a different dosage form for someone who cannot swallow tablets. Our pharmacy FAQ covers common questions about how that works.
A shortage can open the door to compounding, but a prescription and a pharmacist’s judgment still decide who walks through it.
How Patients and Prescribers Should Approach a Shortage
Start with your prescriber. Ask whether an FDA-approved alternative or a different strength is available, then whether a compounded version is appropriate and lawful right now.
For Patients
Try not to ration your remaining supply or swap in a medication on your own, since either can affect your treatment. Call your prescriber’s office and ask what they recommend. If a compounded medication is prescribed, the FDA advises filling it at a state-licensed pharmacy, being cautious with online sellers, and asking exactly how to measure and take your dose.
If something seems wrong with a medication, FDA encourages patients to report problems through its MedWatch program. When you are ready to fill or transfer a prescription, you can request a refill online and our team will follow up.
For Prescribers
Check a drug’s status in FDA’s shortage database rather than relying only on ASHP’s list, since FDA’s listing is what affects 503A compounding. Write a patient-specific prescription that notes the clinical rationale, and coordinate with the pharmacy on formulation and beyond-use dating.
King’s Pharmacy is contracted with nearly all insurance plans and helps doctor offices with insurance troubleshooting, though coverage for any compounded medication varies by plan. Offices looking for a compounding partner can find more on our prescriber page.
Quality Questions to Ask Any Compounding Pharmacy
Compounded medications are not FDA-approved, and FDA does not review them for safety, effectiveness, or quality before they reach patients. That makes the pharmacy’s own standards especially important.
Ask whether the pharmacy is licensed in your state and how it follows USP chapter 795 and 797 standards, which we explain in our post on USP 795 and 797. Ask where its ingredients come from and whether it holds any accreditation. King’s Pharmacy states that it is NABP accredited, and it is licensed in several states beyond California; contact the pharmacy to confirm yours.
Conclusion
With 227 active shortages in the second quarter of 2026, according to ASHP and University of Utah data, many more patients will hear the word “backordered” this year. Two points are worth remembering. FDA’s shortage list is what opens the door for a 503A compounding pharmacy to prepare a copy of a commercial drug, and a conversation with your prescriber always comes first.
Have questions about whether a compounded medication is right for you? Talk to your prescribing physician, then connect with the pharmacists at King’s Pharmacy and Compounding Center in Irvine, CA, to get started.
Request a Refill or Contact King’s Pharmacy at 949.387.0780.
Medical disclaimer: This article is for informational purposes only and is not medical advice. Compounded medications are not FDA-approved and require a valid prescription. Always consult your physician or other qualified health care provider about your medications and treatment; this content is not a substitute for professional medical care.
Frequently Asked Questions
Can a compounding pharmacy make a drug that is on shortage?
Sometimes. When a drug is on FDA’s shortage list, FDA treats it as not commercially available, so a 503A compounding pharmacy may prepare a copy for an individual patient with a valid prescription. Whether it can actually be made depends on ingredient availability, equipment, and expertise.
What does “essentially a copy” mean for compounded medications?
It describes a compounded drug that closely matches a commercially available FDA-approved product. Federal law generally prevents 503A pharmacies from making these copies regularly or in inordinate amounts. The limit does not apply while the drug is on the FDA’s shortage list.
Can I still get compounded semaglutide or tirzepatide now that the shortage is over?
FDA declared both shortages resolved, and the 503A enforcement periods ended in March and April 2025, so routine copies are restricted again. FDA has described limited enforcement discretion, and a prescriber may decide a clinically different formulation is appropriate for a specific patient. Talk with your prescriber about your options.
Are compounded medications FDA-approved?
No. Compounded medications are not FDA-approved, and FDA does not review them for safety, effectiveness, or quality before they are dispensed. They require a valid prescription and are prepared by licensed pharmacies for individual patients.
Does insurance cover a compounded medication during a shortage?
Coverage varies by plan and by medication, so there is no single answer. King’s Pharmacy is contracted with nearly all insurance plans and helps doctor offices with insurance troubleshooting. Contact the pharmacy or your insurer to check your specific situation.
