Yes, compounded medications can be safe when made by licensed, reputable pharmacies that follow proper standards. However, they are regulated differently than regular FDA-approved drugs. States oversee most compounding pharmacies through Boards of Pharmacy, while the FDA provides some federal oversight for larger facilities.
In this article, you’ll learn how compounded medications are regulated, what safety measures protect you, when these custom medicines make sense, and how to find a trustworthy compounding pharmacy.
What Are Compounded Medications?
Compounded medications are custom-made medicines created by pharmacists. Unlike pills you get at a regular pharmacy, these medicines are mixed, combined, or changed to fit your specific needs.
How Compounding Works
A pharmacist takes ingredients and makes a medicine just for you. This might mean:
- Turning a pill into a liquid for easier swallowing
- Removing an ingredient you’re allergic to
- Making a different strength than what’s sold in stores
- Adding flavoring so kids will take their medicine
- Combining two medicines into one dose
Think of it like a baker making a custom cake instead of selling one from the shelf. The pharmacist uses quality ingredients but creates something special for you.
When Doctors Prescribe Compounded Medications
Your doctor might suggest compounded medicine when:
- You’re allergic to dyes, preservatives, or fillers in regular medicines
- A medicine is out of stock or has been stopped
- You need a different dose than what’s available
- You can’t swallow pills and need liquid medicine
- Multiple medicines can be combined for easier use
Compounded medicines help fill gaps when regular medicines don’t work for you.
How Compounded Medications Are Regulated
The rules for compounded medicines are different from regular medicines. Let’s break down who watches over these pharmacies and what rules they must follow.
State Boards of Pharmacy: The Main Watchdogs
Most compounding pharmacies are regulated by State Boards of Pharmacy. Each state has its own board that:
- Gives licenses to pharmacies
- Checks that pharmacies follow the rules
- Does inspections to see if facilities are clean and safe
- Takes action when problems happen
States have different rules, though. Some states check pharmacies more often than others. Some have stricter safety rules than others. This means a compounding pharmacy in one state might follow different rules than one in another state.
The FDA’s Role in Regulation
The Food and Drug Administration (FDA) has some power over compounding, but it’s limited. Here’s what the FDA does:
What the FDA Does:
- Inspects facilities when there are safety concerns
- Investigates problems and outbreaks
- Oversees larger “outsourcing facilities” that make bigger batches
- Sets rules about which ingredients can be used
- Tracks safety reports and complaints
What the FDA Does NOT Do:
- Approve compounded medicines before they’re sold
- Test compounded medicines for safety
- Check if compounded medicines work well
- Inspect most compounding pharmacies regularly
Regular medicines go through years of testing before the FDA approves them. Compounded medicines skip this step. The FDA doesn’t review these custom medicines before patients get them.
Two Types of Compounding Facilities
There are two main types of compounding facilities with different rules:
Section 503A Pharmacies (Traditional Compounding):
- Make medicines based on individual prescriptions
- Regulated mainly by state boards
- Don’t have to follow strict manufacturing rules
- Make smaller amounts for specific patients
Section 503B Facilities (Outsourcing Facilities):
- Make larger batches without individual prescriptions
- Regulated by the FDA
- Must follow stricter manufacturing standards
- Get inspected by FDA on a schedule
- Must report safety problems to FDA
Most compounding pharmacies are 503A facilities, which means state boards are in charge.
Quality Standards: The USP Guidelines
The United States Pharmacopeia (USP) creates standards for making compounded medicines safely. These include:
- USP Chapter 795: Rules for non-sterile compounding (like creams and pills)
- USP Chapter 797: Rules for sterile compounding (like injections)
- USP Chapter 800: Rules for hazardous drug compounding
Many states require pharmacies to follow these standards, but not all states do. This creates another area where rules differ from place to place.
Are Compounded Medications Safe?
Compounded medications can be safe, but they come with more risks than regular FDA-approved medicines. Let’s look at both sides.
Safety Protections in Place
Several things help keep compounded medicines safe:
Quality Ingredients: Compounding pharmacies must use pharmaceutical-grade ingredients from FDA-registered facilities. They can’t just use any chemicals they want.
Licensed Pharmacists: Only licensed pharmacists can make compounded medicines. These professionals have years of training and education.
State Inspections: State boards check pharmacies to make sure they follow safety rules. Inspectors look at:
- How clean the facility is
- What equipment they use
- How staff are trained
- If proper procedures are followed
- Record-keeping and documentation
Professional Accreditation: Some pharmacies get extra certification from groups like:
- Pharmacy Compounding Accreditation Board (PCAB)
- National Association of Boards of Pharmacy (NABP)
These certifications show a pharmacy meets high standards.
Real Risks You Should Know About
Despite safety measures, compounded medications have real risks:
Contamination: The biggest danger is contamination. Poor practices can lead to dangerous bacteria or fungi in medicines. In 2012, contaminated steroid injections from one pharmacy caused a fungal meningitis outbreak. Over 750 people got sick, and 64 died.
Since 2001, researchers have found more than 1,500 adverse events linked to compounding errors, including at least 116 deaths. Most problems came from contaminated sterile products.
Wrong Doses: Compounding pharmacies can make mistakes with:
- Too much active ingredient
- Too little active ingredient
- Wrong measurements
Studies have found that between 11% and 25% of compounded medicines failed quality tests. Drug potency ranged from 0% to 450% in some cases.
No Pre-Testing: Unlike FDA-approved medicines, compounded drugs aren’t tested before you get them. Regular medicines go through years of testing. Compounded medicines don’t.
Inconsistent Quality: Since each batch is made separately, quality can vary. One batch might be perfect while another has problems.
Limited Oversight: Only 22 states do routine inspections of compounding pharmacies. Many pharmacies are never inspected unless there’s a problem.
Children at Higher Risk
Children face special risks with compounded medications. Dosing errors affect kids more often than adults. A small mistake in measurement can be very dangerous for a child’s smaller body.
When to Use Compounded Medications
Compounded medications serve important purposes, but they’re not right for every situation.
Good Reasons to Use Compounded Medications
Consider compounded medicines when:
Allergies or Sensitivities: You’re allergic to dyes, preservatives, gluten, or other ingredients in regular medicines. Compounding lets pharmacists remove these problem ingredients.
Swallowing Problems: You or your child can’t swallow pills. Compounding can turn tablets into liquids, creams, or other forms.
Unique Doses Needed: You need a strength that isn’t made commercially. This is common for children or elderly patients.
Multiple Medicines Combined: You take several medicines that can be combined into one dose. This makes taking medicine easier and helps people remember.
Medicine Shortages: A medicine you need is out of stock. Compounding pharmacies can sometimes create similar versions during shortages.
Discontinued Medicines: A medicine you depend on is no longer made. Compounding might provide an option.
Special Flavoring: Children need medicine that tastes better. Pharmacists can add safe flavorings to make medicine more pleasant.
When NOT to Use Compounded Medications
Avoid compounded medicines when:
- A regular FDA-approved medicine is available that works for you
- You’re buying from an unknown online pharmacy
- The pharmacy can’t provide proof of quality testing
- The pharmacy isn’t licensed in your state
- You’re unsure about the pharmacy’s reputation
Always use FDA-approved medicines when they’re available and appropriate. Compounded medications should be a backup plan, not a first choice.
Safety Concerns and Past Problems
Understanding past problems helps you make smarter choices about compounded medications.
Major Incidents That Changed Regulations
The 2012 Fungal Meningitis Outbreak: The worst compounding disaster happened when New England Compounding Center made contaminated steroid injections. The outbreak caused:
- 753 fungal infections
- 64 deaths
- Cases in 20 states
This tragedy led Congress to pass the Drug Quality and Security Act in 2013, creating stricter rules for larger compounding facilities.
Other Serious Outbreaks: Between 2001 and 2013, there were 19 outbreaks linked to compounding pharmacies. These outbreaks caused:
- More than 1,000 infections
- At least 132 deaths
- Vision loss for many patients
Recent Problems: In 2017, more than 60 people in Texas lost vision from contaminated eye injections. In 2016, 17 cancer patients in New York got fungal infections from contaminated IV medication.
Common Types of Errors
The most frequent problems with compounded medicines include:
Contamination Issues:
- Bacteria in sterile products
- Fungus in injections
- Dirty equipment or facilities
- Poor cleaning practices
Dosing Errors:
- Calculating doses wrong
- Measuring ingredients incorrectly
- Mixing up similar-sounding medicines
Labeling Mistakes:
- Wrong instructions on the bottle
- Missing safety information
- Confusing dosage information
Formulation Failures:
- Medicines that don’t dissolve properly
- Ingredients that don’t mix well
- Products that break down too quickly
Why Problems Happen
Several factors lead to safety problems:
- Lack of routine inspections in many states
- Pharmacies not following proper procedures
- Insufficient training of staff
- Cost-cutting that sacrifices safety
- Pressure to produce large quantities quickly
- No requirement for third-party testing
How to Choose a Safe Compounding Pharmacy
Not all compounding pharmacies are the same. Here’s how to find one you can trust.
Questions to Ask
Before using a compounding pharmacy, ask these questions:
About Credentials:
- Is the pharmacy licensed in your state?
- What accreditations does it have? (Look for PCAB or NABP certification)
- Are the pharmacists board-certified sterile compounding pharmacists (BCSCPs)?
About Quality Control:
- Does a third-party lab test your medications?
- How often do you get inspected?
- Can you provide inspection reports?
- What quality checks do you do on each batch?
About Experience:
- How long have you been compounding?
- How many prescriptions do you compound each month?
- What special training do your pharmacists have?
- Have you had any safety violations?
Red Flags to Watch For
Avoid pharmacies that:
- Won’t answer your questions clearly
- Make big promises about effectiveness
- Claim their medicines are better than FDA-approved drugs
- Sell directly online without requiring a prescription
- Don’t provide a physical address or phone number
- Have had safety violations in the past
- Pressure you to use their services
Signs of a Good Pharmacy
Look for pharmacies that:
- Require a valid prescription from your doctor
- Are licensed and accredited
- Use third-party testing
- Have clean, professional facilities
- Answer questions openly
- Provide clear information about ingredients
- Give detailed instructions for use
- Follow up after you get your medicine
At VillageRx in Glen Ellyn, we follow strict quality standards and maintain open communication with patients about their personalized medication needs.
Special Situations and Considerations
Some situations require extra care when using compounded medications.
Buying Compounded Medications Online
Online compounding pharmacies are convenient but risky. Many patients buy compounded weight-loss drugs, hormone treatments, or other medicines online without knowing who made them.
Dangers of Online Pharmacies:
- You don’t know if the pharmacy is licensed
- The compounder might not meet quality standards
- You can’t inspect the facility
- Fake pharmacies sell dangerous products
- Some use wrong ingredients or wrong forms of drugs
In 2023, the FDA found some online pharmacies selling fake versions of semaglutide (a weight-loss drug) that contained different ingredients than approved medicines.
Safer Online Shopping: If you must buy online:
- Verify the pharmacy is licensed in your state
- Check for VIPPS or NABP certification
- Confirm they require a valid prescription
- Look for a physical U.S. address and phone number
- Read reviews and check complaint records
- Ask your doctor if they recommend the pharmacy
Veterinary Compounding
Compounding isn’t just for humans. Veterinary compounding creates medicines for pets when:
- Commercial pet medicines aren’t available
- Your pet needs a different dose
- Medicine needs to be in a different form
- Flavoring makes medicine more appealing to animals
The same safety rules apply. Choose a pharmacy experienced in veterinary compounding that follows proper standards.
Hormone Therapy and Weight-Loss Drugs
Two types of compounded medicines have raised special concerns:
Bioidentical Hormone Replacement Therapy: Some pharmacies make custom hormone treatments. These are popular but:
- Lack scientific evidence for safety claims
- May have inconsistent doses
- Aren’t proven more effective than FDA-approved options
- Carry similar risks to regular hormone therapy
Weight-Loss Medications: During shortages of drugs like semaglutide, many people turned to compounded versions. Problems include:
- Wrong salt forms of the drug
- Incorrect dosing
- Patients giving themselves 20 times the right dose
- Serious side effects including hospitalization
Always use FDA-approved versions of these medicines when available.
Sterile vs. Non-Sterile Compounding
Sterile Compounding: Makes medicines that go in your eyes or get injected. These require:
- Extra-clean facilities
- Special licenses
- Stricter oversight
- More training
Sterile compounding is riskier because contamination can cause serious infections.
Non-Sterile Compounding: Makes medicines you swallow, apply to skin, or use other ways. Less risky than sterile compounding but still needs proper procedures.
Your Rights as a Patient
You have important rights when it comes to compounded medications.
What You’re Entitled To
Information: You have the right to know:
- What ingredients are in your medicine
- Where the pharmacy sources ingredients
- What testing has been done
- Any risks or side effects
- How to store and use the medicine
- What to do if problems occur
Quality Assurance: You’re entitled to:
- Medicines made in clean, safe facilities
- Proper labeling with clear instructions
- Accurate dosing
- Medicines that meet quality standards
Reporting Problems: If something goes wrong, you can:
- Report issues to your state Board of Pharmacy
- File complaints with the FDA through MedWatch
- Contact the pharmacy directly
- Inform your doctor
- Seek medical attention if needed
Working With Your Doctor
Your doctor plays a key role in safe compounding:
Your Doctor Should:
- Prescribe compounded medicines only when necessary
- Explain why you need a compounded version
- Monitor you for problems
- Know which pharmacy is making your medicine
- Be available if issues arise
You Should Tell Your Doctor:
- About any side effects
- If the medicine seems different than expected
- If you have concerns about the pharmacy
- If you want to try an FDA-approved option instead
Making the Right Choice for Your Health
Compounded medications serve important medical purposes but come with different risks than regular medicines.
Key Points to Remember
Safety Measures Exist:
- Licensed pharmacists make compounded medicines
- States oversee most compounding pharmacies
- Quality standards guide safe practices
- Accreditation programs verify quality
Real Risks Remain:
- Compounded medicines aren’t FDA-approved or pre-tested
- Quality can be inconsistent
- Contamination and dosing errors have caused deaths
- Not all states inspect pharmacies regularly
Use Compounded Medicines Wisely:
- Choose them only when FDA-approved options won’t work
- Pick a reputable, licensed pharmacy
- Ask questions about quality and testing
- Stay alert for problems
- Report concerns immediately
Questions to Ask Yourself
Before using a compounded medication, consider:
- Is there an FDA-approved medicine that could work for me?
- Does my doctor think compounding is necessary for my situation?
- Has my doctor recommended a specific pharmacy?
- Can I verify the pharmacy’s credentials and quality practices?
- Am I comfortable with the risks involved?
Final Thoughts
Compounded medications can be safe when you need them, but they require more caution than regular medicines. They’re regulated, but the oversight system has gaps. Choose wisely, ask questions, and work closely with your doctor and pharmacist.
For trusted compounding services in Glen Ellyn, visit VillageRx. Our licensed pharmacists follow strict quality standards and provide personalized care for your unique medication needs. Whether you need pain creams, oral capsules, or other custom formulations, we’re here to help you safely.
If you have questions about compounded medications or want to discuss your options, contact us today. We’re committed to your health and safety.