Beyond Due Diligence: Ongoing Quality Assurance for Your Compounding Pharmacy Partners

Telehealth brands, med spas and other practices increasingly rely on compounded medications, especially injectables. In October 2026 a set of recalls showed why the quality of those products has to be checked continuously, not once at onboarding.

The October 2026 recalls

FDA's enforcement report of October 14, 2026 lists 16 Class II recalls by Carolina Infusion LLC, recall numbers D-0017-2027 through D-0032-2027 (openFDA enforcement records). The firm started them voluntarily on September 10, 2026. The products include compounded semaglutide, semaglutide/cyanocobalamin, tirzepatide, tirzepatide/cyanocobalamin, sermorelin, and Tri-Mix and Quad-Mix injectables, packaged in single-use syringes and distributed nationwide.

The reason given for every one is "Lack of Assurance of Sterility." For most products the record says it relates to "processing equipment used in compounded product"; for several (for example D-0027-2027, tirzepatide/cyanocobalamin 26/2 mg/mL) it also cites the "formulation using bacteriostic water."

This is not the firm's first sterility recall. The same records show a set of Class II "Lack of Assurance of Sterility" recalls in September 2022 (for example D-1516-2022 and D-1521-2022). FDA's warning letter of May 22, 2023, which followed a 2022 inspection, analyzed the firm's products under section 503A and cited insanitary conditions, including facility design that "allowed the influx of poor-quality air into a higher classified area," media fills not run under the most challenging conditions, and ISO 5 areas not certified under dynamic conditions.

For any practice that prescribes or administers compounded injectables, the lesson is simple: a license and a good first impression do not tell you what the pharmacy is doing this quarter.

Why initial due diligence is not enough

Most practices check a pharmacy's license, look for past enforcement and read its quality statements before they start. Those checks are a snapshot. Equipment ages, staff change, formulations change, and a pharmacy that passed a review two years ago can drift. Ongoing oversight is how you find out before your patients do.

What "lack of sterility assurance" means

An injectable that cannot be shown to be sterile can cause serious infection. The October 2026 records point to two areas:

• Formulation. The records name a formulation using bacteriostatic water. A preservative does not replace aseptic processing; the question is whether the process as a whole prevents contamination.
• Processing equipment. Equipment problems point to failures in sterilization, cleaning, maintenance or design, which can introduce contamination during filling or sealing.

Environmental controls (cleanroom classification, air handling, pressure differentials, gowning) are not named in the 2026 records, but they were central to FDA's 2023 observations at the same firm. They belong on any audit list.

503A and 503B in brief

The Drug Quality and Security Act of 2013 set out two paths, described on FDA's human drug compounding laws page:

• Section 503A compounders must compound "based on the receipt of valid patient-specific prescriptions." When they meet the section's conditions, their products are exempt from FDA approval and from the requirement to carry adequate directions for use. They are licensed and inspected mainly by state boards of pharmacy, which set the compounding standards they must meet. Ask each pharmacy which standards apply to it and how it meets them, including USP General Chapter <797> for sterile preparations.
• Section 503B outsourcing facilities are a voluntary category. "Unlike compounders operating under section 503A, outsourcing facilities are subject to CGMP requirements," and FDA inspects them on a risk-based schedule.

Being a 503A pharmacy does not put a firm outside federal reach. The 2023 warning letter shows FDA inspecting a 503A firm and citing its drugs as adulterated because they were prepared under insanitary conditions.

What to verify before you start

• Licensure. Confirm active licenses with the board of pharmacy where the pharmacy operates and in each state it ships to, including any sterile compounding permit that state requires.
• Accreditation. Ask about voluntary accreditation, such as PCAB accreditation through ACHC, and verify it with the accrediting body.
• Inspection history. Ask for recent state board inspection reports and how each finding was closed. For a 503B facility, or any firm FDA has inspected, search FDA's warning letters and FDA's Enforcement Report for recalls.
• Quality system. Review the QA/QC program: sterility testing, endotoxin testing for injectables, potency testing, beyond-use dating and stability support, and batch release criteria.
• Testing evidence. Ask for certificates of analysis for active ingredients and for examples of finished-product sterility testing (for example, to USP <71>) and potency results, including third-party lab reports.

What to monitor after you start

Regular quality reports. Ask for summaries every quarter or half year: sterility and endotoxin results, environmental monitoring (viable and nonviable particle counts), equipment calibration and maintenance, and aseptic technique qualification of staff.

Complaints and deviations. Ask for de-identified summaries of complaints, deviations and out-of-specification results, and how each was investigated and closed.

Audit rights. Put the right to audit the facility and its quality records, by your team or a qualified third party, in the contract. Audit before significant volume, then periodically, and also after a trigger: a recall, an inspection finding, a quality complaint or an adverse event. On site, look at the sterile compounding area: classification, airflow and pressure differentials, environmental monitoring, equipment logs, training records, observed aseptic technique and adherence to SOPs.

Adverse events. Set an internal process for staff to report patient complaints, suspected reactions and visible product problems (particles, discoloration, damaged packaging). Know how the pharmacy receives and investigates complaints and how fast it responds. Health professionals can report serious adverse events and product quality problems to FDA MedWatch, and your state may have its own reporting rules.

Recall readiness. Know the pharmacy's recall plan: how it identifies affected lots and how it notifies customers. Write and test your own: how you identify which patients received which lot, how you contact them, and how you quarantine and return product. Practices that received the Carolina Infusion products needed exactly this.

Change notification. Require notice of significant changes: key personnel, facility, equipment, formulation (excipients, preservatives), testing methods or regulatory status.

Liability and clinical responsibility

When a practice chooses where its compounded medications come from, that choice is part of patient care. If a defective product harms a patient, a practice can face malpractice claims and board scrutiny of how it selected and monitored its supplier. A documented, ongoing oversight program is far easier to defend than a statement that the pharmacy was vetted once. This is general information, not legal advice; ask your own counsel how it applies to you.

Clinical decisions about which products to use, and from whom, belong to licensed practitioners. In a management services arrangement, the business side can run the paperwork, contracts and audits, but the clinical judgment stays with the medical group.

What to do now

• Write a pharmacy oversight policy covering selection criteria, required documents, monitoring frequency, audit rights, complaints and recalls. Review it at least once a year.
• Update your pharmacy contracts to include audit rights, change notification, complaint and adverse event handling, and recall cooperation.
• Train your staff to report product concerns and to run a recall.
• Check the enforcement reports regularly for every pharmacy you use, not just when news breaks.

Scope your program with TrueEval

TrueEval is a licensed medical group and physician network covering all 50 states plus DC. If you want help setting up physician oversight that includes how compounded medications are sourced and monitored, scope your program with us.