Learn about the laws and oversight behind compounded medications
Omar Khaled
Updated:
April 10, 2025
min read
Compounding pharmacies play a vital role in health care by making compounded medications. These medications are tailored to individual patient needs. However, since these compounded medications do not go through the standard FDA-approval process, they require strict regulatory oversight to ensure that these meds are safe, effective, and in compliance with quality standards.
Different agencies, including the U.S. Food and Drug Administration (FDA), state boards of pharmacy, and professional organizations, oversee pharmaceutical compounding to prevent adverse events and ensure patient safety.
This article will discuss the laws that regulate compounding pharmacies, the responsibilities of compounding pharmacists, and the role of health care providers in ensuring proper labeling, dosage forms, and patient safety.
Compounding pharmacies are regulated by multiple agencies, including the FDA, state boards of pharmacy, and the USP, to ensure the safety and quality of compounded medications.
Compounded drugs, tailored to individual patient needs, must meet strict guidelines for both sterile and non-sterile compounding to prevent contamination and adverse effects.
The Drug Quality and Security Act (DQSA) introduced stricter oversight for compounding pharmacies, following tragic incidents like the New England Compounding Center meningitis outbreak.
Compliance with regulatory standards, such as cGMP and USP guidelines, is critical for health care providers and pharmacists to ensure patient safety and effective treatment outcomes.
Understanding Compounding Pharmacies
Not all prescription drugs are suitable for every patient. Some individuals require compounded medications that eliminate allergens like preservatives or dyes, adjust dosage forms, or provide alternatives to commercially available drugs.
Types of Compounding Pharmacies
Compounding pharmacies fall into two main categories based on their regulatory classification:
1. 503A Compounding Pharmacies
These pharmacies work under Section 503A of the FD&C Act and prepare patient-specific medications based on prescriptions from health care providers.
2. 503B Outsourcing Facilities
These outsourcing facilities are registered under Section 503B. They manufacture larger batches of compounded medications for hospitals and clinics, often addressing drug shortages. They must comply with stricter cGMP regulations.
Both types of pharmacies play important roles in drug compounding, ensuring that patients receive personalized treatments not available through standard drug manufacturers.
Who Regulates Compounding Pharmacies?
Since compounded medications are not subject to the traditional FDA-approval process, several organizations oversee their safety and quality. These agencies establish quality standards, regulate sterile compounding, and monitor adverse events to protect public health.
In this section, different agencies will be discussed.
1. U.S. Food and Drug Administration (FDA)
The FDA plays a key role in overseeing human drug compounding and enforcing safety regulations. While compounded products are exempt from the full FDA approval process, they must still meet high-quality standards.
FDA responsibilities include:
Monitoring outsourcing facilities under Section 503B to ensure compliance with cGMP regulations.
Conducting inspections of compounding pharmacies to identify poor-quality or unsafe practices.
Ensuring that compounded drugs do not contain unapproved or harmful active ingredients.
The FDA.gov website provides guidelines for pharmaceutical compounding, helping health care providers and compounding pharmacists maintain compliance with federal safety regulations.
2. State Boards of Pharmacy
Each state's board of pharmacy is responsible for licensing and inspecting compounding pharmacies. While the FDA sets national standards, state pharmacy boards enforce local regulatory policies and ensure compliance with USP and FD&C Act guidelines.
Key functions of state boards of pharmacy include:
Regulating community pharmacies that prepare compounded medications for individual patients.
Ensuring that licensed pharmacists follow state-specific labeling and dosage form requirements.
Investigating complaints regarding compounded products that fail to meet quality standards.
3. United States Pharmacopeia (USP)
The United States Pharmacopeia (USP) sets national quality standards for compounded drugs, helping compounding pharmacists maintain consistency and safety.
USP guidelines cover two major categories of pharmaceutical compounding:
1. USP 797: Ensures safe sterile compounding, often used for topical creams, injectables, and IV solutions.
2. USP 795: Regulates non-sterile compounding, including oral dosage forms, capsules, and flavored medications.
Compliance with USP standards is essential for preventing contamination, maintaining drug quality, and ensuring the safety of compounded medications.
4. National Association of Boards of Pharmacy (NABP)
The National Association of Boards of Pharmacy (NABP) assists state agencies in enforcing regulatory standards. It ensures that compounding pharmacies comply with federal law, meet safety requirements, and follow best practices for compounded drugs.
The Pharmacy Compounding Accreditation Board (PCAB) provides accreditation to compounding pharmacies that adhere to strict cGMP and DQSA guidelines. Accreditation helps reassure health care professionals and patients that the medications they receive meet high quality standards.
6. American Pharmacists Association (APhA)
The American Pharmacists Association (APhA) advocates for compounding pharmacists, educates health care providers, and promotes safe pharmaceutical compounding practices.
The Drug Quality and Security Act (DQSA) law was enacted in response to the New England Compounding Center meningitis outbreak described above. This law introduced stricter oversight of compounded medications to prevent future adverse events.
The DQSA helps ensure that compounded products are safe, effective, and produced in a controlled environment that meets FDA-approved safety measures.
Why Compliance Matters
Failure to comply with regulatory requirements can lead to serious public health risks. A prime example is the fungal meningitis outbreak caused by contaminated compounded drugs, highlighting the dangers of poor-quality pharmaceutical compounding.
To prevent such incidents, compounding pharmacists must:
Follow FDA.gov guidelines for drug approval and compounded products.
Use only FDA-approved drugs and safe active ingredients.
Adhere to labeling requirements to ensure accurate dosage forms.
Maintain high standards in sterile compounding and non-sterile formulations.
By following these best practices, health care providers, licensed pharmacists, and outsourcing facilities can ensure the safety of compounded medications while meeting federal law and state pharmacy board regulations.
Compounding pharmacies provide customized compounded medications that address specific patient needs, making them a crucial part of health care. However, due to the risks associated with pharmaceutical compounding, they are subject to strict regulatory oversight.
The FDA, state boards of pharmacy, USP, and other agencies enforce quality standards to prevent adverse events and maintain public trust in compounded drugs. Health care providers and compounding pharmacists must stay informed about evolving federal law, cGMP requirements, and DQSA guidelines to ensure patient safety.
For more information, visit FDA.gov, or check with your state board of pharmacy for updates on compounded products and new drugs in human drug compounding.
