by Rich Weil, M.Ed., CDE
Transformation Weight Control
www.transformationweightcontrol.com
Compounding pharmacies are special pharmacies that customize medications for a patient’s special needs. They are legal, and when necessary, will fill a doctor’s prescription to precise instructions to meet the needs of the patient. According to the American Pharmacists Association there are roughly 56,000 pharmacies in the United States, 7500 of them (13%) are compounding. Your local pharmacy may even compound medications without you ever knowing it.
When Are Compounding Pharmacies Used?
There are a few conditions under which a compounding pharmacy can manufacture a medication. They are when:
1. The FDA (Food and Drug Administration) declares that there is a shortage of an FDA approved medication,
2. The standard approved medication does not meet the patient’s needs, such as
a) the dose the standard medication comes in is not appropriate,
b) the route of administration is objectionable to a patient; some patients may have a problem with one of these routes: oral, injectable, rectally, capsules, creams, or liquids,
c) change the flavor of a medication (e.g., for children),
d) some people would just prefer a tablet over an injection, and there could be many reasons for this, including simply the inconvenience of carrying an injection pen with them (e.g., during travel), they may be squeamish about an injection, or
e) reformulate a medication if the patient is allergic to a specific ingredient (e.g., gluten).
Physicians can prescribe a compounded medication to any specification they want when any of the above criteria are met. For the purposes of this blog, of course, we’re talking about the regular, consistent shortage of GLP-1 receptor agonist weight loss medications such as Zepbound, Mounjaro, Wegovy, Ozempic, Saxenda, or Victoza. Compounding pharmacies have jumped all over this opportunity because of the shortage and very high demand. Unfortunately, not all compounding pharmacies are the same; some follow the rules, some don’t. More about that shortly.
Who Can Compound a Medication?
All pharmacists are taught how to compound medications in pharmacy school. Then many states test the pharmacist’s knowledge and skill before issuing a license. Once they are licensed, they may compound in a pharmacy they own or work in using FDA approved ingredients. Special equipment is necessary for compounding, and if a pharmacy does not have this equipment, they may send it out to an accredited laboratory that uses FDA-approved ingredients.
Counterfeit Medications?
Be aware that high demand for weight loss medications and the shortages has spawned a very lucrative world-wide criminal enterprise. Counterfeit meds are being sold worldwide that have made people sick, hospitalized, and some have died. Sometimes they sell insulin instead of the weight loss meds, or they use other suspensions or ingredients that have nothing to do with the weight loss medication, or they use non-FDA approved ingredients. There are even counterfeit delivery system pens, and un-sterile needles. Novo Nordisk and Eli Lilly have dozens of lawsuits against disreputable doctors, pharmacies, spas, online sites, and others because they are selling counterfeit meds. Be sure to read my blog, “A Pictorial Guide to Counterfeit GLP-1 Receptor Agonist Weight Loss Medications.”
How Do I know If a Compounding Pharmacy Is Legitimate?
All compounding pharmacies must be accredited. First thing to do once you find a compounding pharmacy online, or by word of mouth, or from some online forum, is check them out at the three sites below. The third one lists literally thousands of sites online, as well as spas, wellness centers, pharmacies, physician offices, and more, that are not recommended.
1. https://www.achc.org/ Accreditation Commission for Health Care (ACHC)
2. https://www.pharmacist.com/Practice/Patient-Care-Services/Compounding/Compounding-FAQs
3. https://safe.pharmacy/not-recommended-sites/
What Else Should I Do to Make Sure a Compounding Pharmacy is Legitimate?
1. Ask them if they are accredited. Then ask for proof.
2. Ask what the source of the ingredients are and if they are FDA-approved.
3. If they use a lab for manufacturing compounded medications, ask for the name of the laboratory, if that laboratory is accredited, and if they are using FDA approved ingredients. Ask for the phone number to call and confirm.
4. Ask your doctor if he or she uses a reputable compounding pharmacy, or if not, would they be willing to call one you find and speak with the pharmacist. The doctor will know what to ask and they should grill the pharmacist on all the issues I’ve already described.
IF THE PHARMACIST AT ANY COMPOUNDING PHARMACY IS UNWILLING TO SPEAK WITH YOU OR YOUR DOCTOR AND PROVIDE THIS INFORMATION THEN YOU SHOULD NOT USE THEM. YOU OR YOUR DOCTOR SHOULD ALWAYS SPEAK WITH THE PHARMACIST.
Some Compounding Pharmacy Problems You May Run Into
Be sure to ask if the weight loss medication is going to come with a pen delivery system like the ones Lilly and Novo provide, or are you going to get syringes (usually insulin syringes) and vials of the medication that you have to draw up yourself before injecting. You would receive enough medication in the vial and syringes to get you through the month no matter what prescription your doctor writes for. This may be a viable option for some of you. People with diabetes for decades had to draw up their insulin and inject it until pens were available for insulin, but you have to be really sure you’re willing to do this and have a health-care professional show you how to do it ad that your private physician approves.
Sometimes compounding pharmacies don’t manufacture the medication themselves. Instead, they send it to an independent lab (or pharmacy), the lab manufactures it according to the doctor’s prescription, and then they ship it to you directly. If this is the case, you must find out which lab or compounding pharmacy they use, get in touch with that operation, and follow all the rules above about accreditation, FDA-approved ingredients, etc. Again, if the pharmacist will not provide this information, then hang up the phone.
Who Watches Over the Compounding Pharmacies?
1. Compounding pharmacies are regulated by the state boards of pharmacy and subject to oversight by state and/or federal authorities.
2. The FDA, as I mentioned, oversees the safety of the ingredients used in compounded ingredients. Those ingredients must be FDA approved.
3. Controlled substance such as opiates and narcotics are overseen by the Drug Enforcement Administration.
4. The United States Pharmacopeial (USP) Convention applies standards to compounding pharmacies and labs. They develop standards for the quality and purity of the compounding ingredients.
5. As a reminder, always check for accreditation with the Accreditation Commission for Health Care that I mentioned above.
Why You Might Consider a Compounding Pharmacy and Other Things to Think About
1. You will never run short of the drug. They make it to order in any dose.
2. The medications will be much less expensive than the original medications.
3. These are generic drugs. For instance, if you want Wegovy, you will not receive a medication with Wegovy on the package. Instead, if it’s Wegovy you want, then you will receive the generic version called semaglutide which is the active ingredient in Wegovy (which is also Ozempic).
4. Your doctor can send in the prescription to meet your specific needs if the standard medication does not.
5. Always find out the turn-around time for the manufacture of the compounded medication. It’s often 2 to 5 days, but it could be more, so you need to account for the lead time and shipping so you don’t run out before you receive the new supply.
Before You Take the Final Step
In ALL cases, you MUST discuss the use of a compounded medication and pharmacy with your physician. This is a critical step to assure that you are receiving a legitimate product. Do NOT just trust an online pharmacy where a doctor is not involved, and even if a doctor is, you should still discuss it with your private physician.
It’s estimated that only about 8% of the people who need to be taking GLP-1s for weight loss or diabetes are taking them. I happen to think it may even be less than 8%. With only this many people taking them (even though it seems like everyone is), it’s going to be years before the pharmaceutical companies catch up with the demand. So, compounding may be an option. But again, you must be certain beyond doubt that the compounding pharmacy is following all the rules and that your doctor approves. This is serious business and should not be approached causally. There are many disreputable people out there waiting to take advantage of the weight loss medication shortages, particularly the GLP-1s, the high demand, and the desperation of people who want them. Make sure you do your due diligence and go through all the steps I mention in this blog, and again, finally, run all of this by your private physician.
©️2024 Richard Weil, M.Ed., CDE All Rights Reserved