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Table of Contents
- What Is Pharmacy Compounding?
- Types of Compounding Errors
- The 2012 New England Compounding Center Tragedy
- Sterile Compounding Standards
- New York Regulation of Compounding Pharmacies
- Proving Negligence in Compounding Cases
- Who Can Be Held Liable?
- Damages and Statute of Limitations
- Frequently Asked Questions
What Is Pharmacy Compounding?
Pharmacy compounding is the practice of creating customized medications for patients whose needs cannot be met by commercially available, FDA-approved products. Compounding may be necessary when:
- A patient needs a medication in a different form (e.g., liquid instead of a pill for a child or elderly patient who cannot swallow)
- A patient needs a different strength than what is commercially available
- A patient has an allergy to an inactive ingredient in a commercial product
- A medication is in short supply and must be prepared from raw ingredients
- A patient needs a combination of medications in a single preparation
Compounding is performed by pharmacists or pharmacy technicians under the supervision of a pharmacist. While compounding serves an important medical need, it carries inherent risks because compounded products are not subject to the same FDA approval, manufacturing standards, and quality control processes as commercial medications.
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Types of Compounding Errors
Contamination of Sterile Products
The most dangerous compounding error is contamination of sterile preparations — particularly injectable medications. When a compounded sterile preparation (CSP) is contaminated with bacteria, fungi, or endotoxins, the patient receiving the injection can develop:
- Bacterial or fungal meningitis — From contaminated epidural or intrathecal injections
- Sepsis and septic shock — From contaminated IV preparations
- Endophthalmitis — From contaminated intraocular injections
- Soft tissue or joint infections — From contaminated injections
Wrong Concentration
When a compounded medication is prepared at the wrong concentration, the patient receives either too much or too little of the active ingredient. This can result from:
- Calculation errors
- Measurement errors
- Using the wrong raw ingredient
- Dilution errors
Wrong Ingredient
Compounding errors can involve using the wrong active pharmaceutical ingredient (API), particularly when raw ingredients have similar names or appearances.
Improper Preparation Technique
Compounded preparations must follow specific formulas and techniques. Errors include:
- Incomplete mixing — The medication is not uniform throughout the preparation
- Improper pH — The preparation is too acidic or alkaline, causing tissue damage when injected
- Particulate matter — The preparation contains particles that should have been filtered out
- Inadequate sterilization — The preparation is not properly sterilized for injectable use
Labeling Errors
Compounded medications must be properly labeled with:
- The active ingredient(s) and concentration
- The route of administration
- The expiration date (beyond-use date)
- Storage instructions
- Batch/lot number
- Compounding pharmacist identification
Labeling errors can lead to wrong-drug, wrong-dose, or wrong-route administration errors.
The 2012 New England Compounding Center Tragedy
The dangers of compounding pharmacy negligence were tragically illustrated in 2012, when the New England Compounding Center (NECC) in Framingham, Massachusetts, distributed contaminated steroid injections (methylprednisolone acetate) to healthcare facilities across the United States. The contaminated medication caused a multi-state outbreak of fungal meningitis that:
- Sickened 753 patients across 20 states, including New York
- Caused 64 deaths
- Resulted in the largest documented healthcare-associated infection outbreak in U.S. history
The investigation revealed that NECC had:
- Failed to maintain sterile compounding environments
- Shipped medications before confirming they were sterile
- Used expired ingredients
- Ignored environmental monitoring results showing contamination
- Operated as a manufacturer while registered as a compounding pharmacy
The NECC tragedy led to the passage of the Drug Quality and Security Act (DQSA) in 2013, which established a new regulatory category of "outsourcing facilities" for compounding pharmacies that produce large quantities of compounded products.
Sterile Compounding Standards
USP <797> Standards
The United States Pharmacopeia (USP) Chapter <797> sets the standards for sterile compounding. Key requirements include:
- Cleanroom facilities — Sterile compounding must be performed in an ISO Class 5 environment (e.g., a laminar airflow workbench or biological safety cabinet) within an ISO Class 7 or 8 cleanroom
- Personnel training and competency — Compounding personnel must be trained and evaluated in aseptic technique
- Environmental monitoring — Air and surface sampling must be performed regularly
- Garbing — Personnel must wear appropriate personal protective equipment (gowns, gloves, masks, hair covers)
- Beyond-use dating — Compounded sterile preparations must have appropriate expiration dates based on risk level
- Quality assurance program — A formal QA program must monitor compounding practices
USP <795> Standards
USP Chapter <795> sets standards for non-sterile compounding, including:
- Appropriate facilities and equipment
- Ingredient quality and verification
- Documentation and record-keeping
- Quality control
USP <800> Standards
USP Chapter <800> sets standards for handling hazardous drugs, including:
- Use of containment primary engineering controls (C-PEC)
- Appropriate personal protective equipment
- Environmental monitoring
New York Regulation of Compounding Pharmacies
New York State Board of Pharmacy
Compounding pharmacies in New York are regulated by the New York State Board of Pharmacy under the New York Education Law, Article 137 (Pharmacy). Key requirements include:
- Pharmacy registration — All compounding pharmacies must be registered with the Board
- Pharmacist licensure — Compounding must be performed under the supervision of a licensed pharmacist
- Inspection — The Board may inspect compounding pharmacies for compliance with standards
- Adverse event reporting — Pharmacists must report adverse events related to compounded products
New York State Department of Health
Under PHL § 2805-j and 10 NYCRR § 405, hospitals that purchase compounded products must ensure that the compounding pharmacy meets applicable standards. Hospitals can be held liable for failing to verify the quality of compounded products they purchase and administer.
Proving Negligence in Compounding Cases
Evidence to Collect
- Compounding records — Formulas, preparation logs, batch records
- Environmental monitoring data — Air and surface sampling results
- Personnel training records — Competency evaluations, training documentation
- Quality assurance records — QA program documentation, corrective action records
- Product samples — Retained samples of the compounded product (if available)
- Laboratory testing results — Microbiological testing of the product
- Shipping and receiving records — Chain of custody for the compounded product
Expert Testimony
Compounding cases require specialized experts:
- A compounding pharmacist to testify about USP standards and compounding practices
- A microbiologist or infectious disease specialist to testify about contamination and its consequences
- A physician expert to testify about the medical consequences of the compounding error
Establishing Breach
Breach of the standard of care in compounding cases is established by showing:
- Failure to maintain a sterile compounding environment
- Failure to follow USP <797> standards
- Failure to perform environmental monitoring
- Use of expired or contaminated ingredients
- Failure to properly label compounded products
- Distribution of compounded products before sterility testing was complete
Who Can Be Held Liable?
The Compounding Pharmacy
The pharmacy itself is liable for the negligence of its pharmacists and technicians under the doctrine of respondeat superior. The pharmacy can also be held directly liable for:
- Failing to maintain adequate facilities
- Failing to implement quality assurance programs
- Failing to train and evaluate personnel
- Failing to follow USP standards
The Compounding Pharmacist
Individual pharmacists can be held liable for:
- Deviating from standard compounding procedures
- Failing to verify ingredients
- Failing to maintain sterile conditions
- Failing to properly label products
The Prescribing Physician
In some cases, the prescribing physician may share liability if they:
- Prescribed a compounded product when a commercial alternative was available
- Failed to verify the compounding pharmacy's credentials
- Prescribed an inappropriate formula or concentration
The Hospital or Clinic
Hospitals and clinics that purchase and administer compounded products can be held liable for:
- Failing to verify the compounding pharmacy's compliance with standards
- Failing to inspect the product before administration
- Failing to monitor the patient for adverse reactions
Damages and Statute of Limitations
Damages
New York does not cap medical malpractice damages. Compensation may include:
- Medical expenses — Treatment of infections, organ damage, or other complications
- Lost wages — Past and future
- Pain and suffering
- Loss of consortium
- Wrongful death damages under EPTL § 5-4.1
Statute of Limitations
| Claim Type | Deadline | Legal Basis | |---|---|---| | Malpractice against pharmacist | 2.5 years | CPLR § 214-a | | Products liability against pharmacy | 3 years | CPLR § 214 | | Wrongful death | 2 years from death | EPTL § 5-4.1 |
Frequently Asked Questions
What is a compounding pharmacy?
A compounding pharmacy creates customized medications for patients whose needs cannot be met by commercially available, FDA-approved products. Compounding may involve changing the form (liquid vs. pill), strength, or ingredients of a medication.
What are the most dangerous compounding errors?
The most dangerous compounding errors involve contamination of sterile injectable products. Contaminated epidural or intrathecal injections can cause fungal meningitis, while contaminated IV preparations can cause sepsis and septic shock.
What are USP <797> standards?
USP Chapter <797> sets the national standards for sterile compounding. It requires specific cleanroom facilities, personnel training, environmental monitoring, and quality assurance programs. Compliance with USP <797> is the standard of care for sterile compounding.
Can I sue the compounding pharmacy if I was given a contaminated product?
Yes. The compounding pharmacy can be held liable for negligence under medical malpractice law (CPLR § 214-a, 2.5-year SOL) and/or products liability law (CPLR § 214, 3-year SOL), depending on the nature of the claim.
How is a compounding error investigated?
An investigation involves obtaining compounding records, environmental monitoring data, personnel training records, quality assurance records, product samples, and laboratory testing results. Expert testimony from a compounding pharmacist and microbiologist is essential.
What if I was infected at a hospital that purchased the compounded product?
Hospitals that purchase compounded products must verify that the compounding pharmacy meets applicable standards. If the hospital failed to verify the pharmacy's credentials or inspect the product, the hospital can share liability.
This article is for informational purposes only and does not constitute legal advice. Prior results do not guarantee a similar outcome. No attorney-client relationship is created by reading this article or contacting MDLaw Firm.
If you or a loved one suffered from a medication error, contact our Medication Error lawyers today for a free, confidential consultation. Call 347-524-5777 or request a case review online.