Most people never need compounded medications, and, therefore, never think about compounding pharmacies. Then, something occurs, a medication is prescribed that needs to be a different strength, a child is unable to swallow pills, an adult has an allergic reaction to an inactive ingredient in a standardized medication. When the need for precision arises from a pharmacy that can compound and customize a medication, not all such pharmacies are created equal.
Compounding is the act of creating medications from scratch for specific patient needs. This does not mean crushing up tablets and mixing them in a cup. Instead, quality compounding pharmacies use raw pharmaceutical active and inactive ingredients to create customized medications per prescription order. This means changing the formulation from tablet to liquid, for example, or using one percentage of a formulation instead of the commercially available amount.
The challenge is that compounding requires quality control knowledge, elements, and techniques that take a compounded pharmacy above and beyond normal retail pharmacies. Therefore, some Pharmacies say they provide compounding, but without special setups and know-how, they cannot truly offer such services. In contrast, those that produce quality compounded medications go undiscovered because patients don’t know what to ask.
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Accreditation and Training that Matters
The first thing to ask about is whether the pharmacy has received accreditation through the Pharmacy Compounding Accreditation Board (PCAB). This is not just a certificate on the wall; instead, it means that the pharmacy has passed extensive inspections of both facilities and procedural qualities to confirm quality and safety for patients through pharmaceuticals and pharmaceutical activities. PCAB accreditation is voluntary. If a pharmacy seeks this process out, it shows that they mean business.
In addition to accredited facilities, the pharmacists themselves should boast specialized training for compounding endeavors. This means at least certification beyond their initial training as a pharmacist. The Professional Compounding Centers of America (PCCA) provides training programs with many reputable compounding pharmacists having completed this assessment. In addition, some pharmacists have even gone so far as to be board-certified in compounding offered through the Board of Pharmacy Specialties.
Why does this matter? Because most pharmacy schools do not spend much time teaching about compounding anymore, it has become its own specialty. Therefore, any pharmacist who graduated 20 years ago while compounding was still being taught in standard pharmacy schools has more foundational knowledge than a recent grad, unless that recent grad sought out additional training. Thus, when asking about educational credentials for compounding knowledge and not just how long they’ve been a pharmacist matters.
The Equipment and Facilities Set-Up
If you walk into a quality compounding pharmacy versus a normal pharmacy, you’ll know immediately something is different. There should be an area dedicated to compounding that is not where prescriptions are filled; this is essential for quality control considerations as it can be dirty from other medications if they are prepared in the same area.
For sterile compounding (medications needing to be sterile, like injectables or eye drops), additional requirements include what’s called a clean room, ISO-classified environments with air filtration, pressure control, and regulations on what can come in. Not every pharmacy does sterile compounding, and that’s fine, but if they say they do, they need these facilities.
Additionally, the equipment matters too. A reliable pharmacy will only invest in quality, analytical balances that can measure minuscule amounts accurately, ointment mills for topical preparations, sterility instruments more premium than those found at your corner shop. These instruments are expensive. Maintaining them is an investment in time and money over time.
When patients turn to their options for serious compounded medication needs, they often turn to https://northcenturypharmacy.com/ and similar organizations where they know the pharmacy has various capabilities all backed by the right equipment with trained professionals.
Testing Procedures and Quality Control Processes
Where it gets technical is where it gets good, or bad. Quality control procedures are key. A quality compounding pharmacy does not just mix and hope for the best; instead, they have testing options for verification.
A great test facility sends samples out to labs, some have labs on site, but either way, testing happens on compounded medications as the first line of defense. A quality pharmacy can explain how they test various medications for potency (sterile or not) and others when applicable.
In addition to those lab tests, there should also be written documentation of everything about tested and non-tested compounded medications; how they test them, how they clean their equipment used in preparation, how ingredients are sourced for quality (or rejected), how raw materials are used/transferred/stored, and how employees are trained, all of this should be documented and adhered to with no question asked. Yes, this sounds bureaucratic, but when you’re customizing medications from scratch for people with specific needs, detail saves lives.
Ingredient Sourcing and Accountability
The easiest way to mess up a compounded medication is to use subpar ingredients. Legitimate compounding pharmacies source their raw materials from FDA-registered suppliers and have documentation on where each ingredient comes from to use them.
They will also have records on every batch tracked, lot numbers assigned when a group expires with certifications of analysis, so if there’s ever a problem with one supplier’s ingredients down the line one day, they can figure out which patients received those lot numbers made with that batch of ingredients.
Those who source from unofficial companies either look for cheaper prices or attempt to get them from abroad with suspicious regulations, it’s a huge red flag. The costs do not matter; it’s not worth the effort in saving when ingredients are subpar or contaminated.
Communication is Key
A good pharmacy doesn’t just fill in a prescription without asking questions all day long; instead, pharmacists should consult prescribers about what’s best for their particular patients when something can be done differently or if what’s being prescribed sounds good in theory but isn’t the best practical option for compounding.
In addition, when receiving compounded medications, there’s more to it than what meets the eye; storage differs based on formulations; shelf lives may be different than commercially produced products, and someone needs to explain how to use the new compounded solution versus what was originally planned on using; otherwise, it defeats the purpose.
If a pharmacist can’t answer these questions or only rushes through without compassion, there’s a big problem. Compounding requires attention to detail and good communication; if someone cuts corners in patient-pharmacist communication, they cut them elsewhere too.
Specializations
Some compounding pharmacies may specialize in certain areas, hormone replacement therapy compounded medications differentiate themselves from veterinary options versus pediatric ones or pain management versus dermatological compounded solutions, and if this occurs, finding someone with particular experience in the field can go a long way.
Often these specialized pharmacies work collaboratively with doctors who frequently prescribe compounded solutions for specific situations. They know what’s best for each situation instead of generalizations that might complicate easy solutions down the road.
Red Flags
There are good signs there are bad pharmacies based on appearance alone if they refuse or cannot show you their compounding area if they’re vague about their quality control procedures and get defensive about their testing efforts, get away from there.
If their pricing seems drastically lower than other places, question why, and if it’s because quality materials cost money, it’s worth it. Never pay less for subpar compounded medication efforts.
Additionally, watch out for those who promote compounded solutions per compelling suggestion, compounded medications are better suited than commercially available products solely because they can charge more, this isn’t right. Compounded solutions should be considered only if 100% necessary.
Making a Decision
Ultimately, making a decision should not be based on convenience or price of location alone. Quality matters more than dollars spent, and when supplies are made specifically per patient needs with compromised satisfaction on the line, it pays to ask more questions from professionals willing to make it worthwhile instead of saving hospitals time or money.
When there is an opportunity for help needed down the road, knowing who compiles good pharmacies makes all the difference between getting quality help and living on jeopardy upon poor preparations made.