When it Comes to Natural Hormone Balancing a Compounding Pharmacist is your Friend: How to find the right one

When it comes to balancing your hormones with bioidentical approaches, getting to know a  reliable, compounding pharmacist in your area is an essential first step. Few traditional pharmacists better understand the biochemistry of hormones in the body, or can tailor a prescription to individual need based on hormone test results. And if you have a problem swallowing pills, a skilled compounder can solve that with sublingual troches that taste good while dissolving under the tongue, non-allergenic topical creams that can be applied anywhere on the skin, or vaginal suppositories, nasal sprays, drops, tinctures, you name it! Many of these specially designed delivery systems are so effectively absorbed by the body it takes much less hormone to achieve much greater benefit… the so-called “Goldilocks” approach to dosing hormones appropriately – not too much nor too little, but just right!

Woman reading studying, reading

Looking for safe solutions to hormone balance? It’s important to get all the facts and ask the right questions to find a GOOD compounding pharmacist.

Every since the WHI (Women’s Health Initiative Study) found that synthetic hormones like those used in common HRT combinations, increased risks for stroke, heart attack, blood clots, and breast cancer, compounding pharmacists across the country have become key players in the shift to natural hormones and the Bioidentical Hormone Restoration model, a.k.a. BHRT, where patients, providers, and compounders partner to detect and correct imbalances that diminish health …not to mention energy, mood, memory, strength, libido…I could go on…and on!

As happens every now and then, the bad practices of one pharmacy can cast aspersions upon all. In one such incident last year, a pharmacy in Massachusetts used improper procedures in formulating a sterile medication which led to an outbreak of meningitis and the death of hospital patients injected with the toxin. In light of this tragic event, it seems appropriate to clarify that it is exceedingly rare and to talk about the regulation of pharmacy, and safety measures that GOOD compounders use.

For starters, all compounding pharmacies are subject to government oversight by three different regulatory agencies: 1) the State Board of Pharmacy, which ensures adherence to state laws and good pharmacy 2) the FDA, which regulates the integrity of the drugs and active ingredients compounders purchase; and 3) the DEA, which regulates how compounding businesses buy and dispense controlled substances.

Evidently, the pharmacy in Massachusetts, (the New England Compounding Center)  had previously received warning letters from the FDA, ignored safety guidelines, and, had illegally shipped prescriptions to states in which they were not a licensed pharmacy. Not only was the purity of the chemicals they used questionable given the meningitis outbreak, this particular facility was known as an “outlier” in the compounding world.  According to Natalie Gustafson, RPh., and owner of Pacific Compounds and Lloyd Center pharmacies, in Hillsboro, and Portland, Oregon, “these people were not even closely representative of how most pharmacies operate, which is to put the patient first and to have numerous quality control measures in place to ensure the safety of patients and employees alike.”  Natalie, and her assistant, Pharm-Tech, Cory Dolan, emphasize that to find a compounder you can trust absolutely, it is essential that you talk with them and ask the following key questions:

  • Have you passed inspection by your governing bodies: The State Board of Pharmacy: FDA and the DEA? Have you ever been written up by your State Board?
  • Are you licensed by PCCA (Pharmaceutical Compounding Centers of America)?
  • Do you use only pure USP grade chemicals?
  • Do you run any outside testing of the sterility and potency of your formulations by impartial labs?
  • Do you have safety measures in place like human checks of  all prepared formulas in addition to computer checks?
  • Do you individually label, bar-code, and record the chemicals used in your formulations?
  • Do you have a clean room (with powder hood, etc.) to reduce cross-contamination?
  • Do you use the latest technology your industry has to offer?
  • Do you and your staff regularly obtain continuing education credits and training?

Bottom line: Your compounder is your friend, if and only if, they can answer all the questions above with resounding positives!

How to find a good compounder? Easy. Get to know who has a name in your area. Talk to your provider and find out who she/he recommends, or visit PCCA’s website: www.pcca.com or International Academy of Compounding Pharmacists: www.iacprx.org  for a list of trained compounders  by zipcode. Conversely, if you are looking for a provider (see my July 31, 2012 post: How to Find a Natural-Hormone Friendly Provider) your compounding pharmacist is an excellent resource since they know all the docs in town who know what they’re doing when prescribing bioidenticals. ZRT Laboratory, a top hormone testing lab in the country has a great provider resource directory that includes providers and compounders at www.zrtlab.com

African American woman window shopping

Stop by your local compounding pharmacy…Ask if they have a viewing room where you can check out their “clean room”  and see pharmacy technicians in sterile garb hard at work preparing your personalized prescription.

Once you find someone that sounds good, stop by their pharmacy. Check out their premises, the levels of cleanliness, certificates and registrations of their technicians, available information and resources. A top level facility should ideally have a viewing window where you can observe technicians hard at work under the hood, in the clean room, attired as they should be in the appropriate sterile garb, etc.. A GOOD compounder should offer medical professionals and interested patients tours of their lab and safety procedures. These are the kinds of things to look for so that you can trust your compounder without a shadow of a doubt.

Please chime in to this conversation if you yourself happen to be a compounding pharmacist,  natural friendly hormone provider or concerned health care consumer looking for hormone balance!! Tell us your experience of working with compounders and stay tuned for Kyle’s upcoming blog post from the provider perspective!

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21 Comments

Filed under Women's Health & Happiness

21 responses to “When it Comes to Natural Hormone Balancing a Compounding Pharmacist is your Friend: How to find the right one

  1. Another good post Candace. Choosing the right compounding pharmacy is very important. I’ve visited at least 8 – 10 pharmacies here in Oregon, and several in California and Nevada and am quite stunned at the difference. While all ingredients used by compounding pharmacies to make compounds come from FDA-registered and inspected facilities, not all compounding pharmacies are alike when it comes to quality and pharmacist expertise. Although all compounding pharmacies are regulated by their state boards of pharmacy, the highest accreditation that a compounding pharmacy can achieve and SHOULD achieve in our opinion is PCAB Accreditation. Out of 7500 compounding pharmacies only around 125 across this country have PCAB Accreditation, and only 3 in the state or Oregon. The AMA recognizes PCAB Accreditation and strongly encourages all state boards of pharmacy to require compounding pharmacies in their states to obtain the PCAB Seal of Accreditation. Our patients can go where they want.. but we always recommend PCAB Accreditation and its where we would get our compounding as well as send our family members.

  2. candacebwell

    Daniel, BIG thanks for sharing this important information…can you tell us what a pharmacy must do to earn this accreditation …that is how does the pharmacy that has it differ from one that does not…?

  3. Hello, Candace. Thanks for the reference to our organization, International Academy of Compounding Pharmacists. Would like to note that our website URL is http://www.iacprx.org versus .com, so that your readers can find us. IACP has a pharmacist locator service, CompounderConnect that provides a zip code search to pharmacists in their area, or they can call toll free to 800/927-4227. Thanks again!

    • candacebwell

      Hi Dagmar,
      Thanks so much for reading the blog and providing more information about the great resource IACP provides as a non-profit organization serving providers and patients looking for safe solutions to hormone replacement and restoration. I now have the .org corrected in the blog post so that my readers will be able to find you and take advantage of the news and views across the international compounding community.
      Many thanks!

      • Thank you Candace for a terrific overview on how to choose an excellent compounding pharmacist. Stay tuned readers and I will share my own journey with compounders and how they turned around the way I practice medicine into a more holistic and integrative approach.

  4. In the wake of the New England Compounding Meningitis outbreak, why any hospital or clinic would use a non PCAB Accredited pharmacy, especially for injectables, is beyond me. PCAB accredited pharmacies have gone the extra mile to demonstrate that they comply with nationally accepted quality control, quality assurance and quality improvement standards. PCAB also requires monthly testing of a percentage of the medicines pharmacies compound for bacteria, fungi and other endotoxins. Non-accredited pharmacies typically aren’t required to do that unless they engage in batch compounding, or make medications intended for use by more than 25 people. For most accreditation is a $2500 a year investment. In the gold mine of compounding medications that’s a small price to pay to ensure the pubic is getting the gold standard when it comes to compounded medications. Are there good non PCAB pharmacies out there? You bet. But for me, especially when it comes to injectable medications, I’m choosing PCAB.

  5. Cory

    Any compounder can have their medications tested, which of course Lloyd Center Pharmacy and Pacific Compounds Pharmacy both have their compounds tested by an independent laboratory. This is only common sense for good compounders who want to offer excellent and safe medications to their patients. The reason hospitals don’t look at PCAB is because PCAB inspects a pharmacy only once every three years! This is not sufficient for the safety concerns of a hospital and the standards the hospitals expect are higher (more stringent) than the PCAB standards. Hospitals want to do their own inspections on a surprise basis (not a scheduled inspection like a PCAB inspection) and the inspections done by hospitals occur much more frequently than PCAB inspections. Lloyd Center Pharmacy works with OHSU, St. Vincent’s and other area hospitals, so it is inspected by many hospitals throughout the year and meets the higher standards hospitals set for compounding. Since PCAB standards are a downgrade from hospital standards, the PCAB certification would be less desireable for pharmacies that are already meeting the higher standards set by hospital inspections.

  6. candacebwell

    Thanks for the clarification Cory and Natalie which helps us all to better understand the pros and cons of this issue. Meanwhile, keep up the stellar work at Pacific Compounds and Lloyd Center …your pharmacies have been recognized for many years now as key players in that all-important triad of provider, patient, compounder working together to help make the shift from HRT to BHRT and from hormone imbalance to balance.

  7. Its apparrant their is a lot of opinions about accreditation, including our own to guide our patients toward PCAB accredited pharmacies. I contacted the PCAB itself and asked that they respond to the above comments. Regarding Lloyd Center, it is a great pharmacy. Don West did amazing job at creating a top notch compounding pharmacy. Like I said, I’ve visited nearly every compounding pharmacy that our patients have ever done business with and Lloyd Center was the most impressive by far of any non PCAB pharmacy. We do have patients that choose Lloyd Center and other non PCAB pharmacies and they all have that right to choose for themselves. I simply don’t get why Lloyd never got PCAB as to distinguish themselves from the rest. The cost is minimal compared to the profit that comes from compounding. Below is the PCAB response to the above comments:

    “PCAB certification is one tool a compounding pharmacy can use, but you pay them to pass your pharmacy…*

    As a non-profit voluntary accreditation organization, our organization is supported by fees from our applicants, but pharmacies must meet our stringent standards to get accredited. No pharmacy pays PCAB to “pass their pharmacy”. In fact, approximately 20% of our applicants pay their fee and do not get accredited. Our accreditation fees are minimal compared to the cost of achieving and maintaining accreditation. There is a cost to quality compounding. Accredited pharmacies have gone that extra mile and made that commitment.

    *and they only come to inspect your facility once every three years!*

    3 years is the generally accepted survey interval in the healthcare industry. The Joint Commission, the accreditation organization for
    hospitals, performs onsite inspections every 3 years, as do most other healthcare accrediting organizations.

    * If you are compounding for hospitals like OHSU and St. Vincents like
    Lloyd Center Pharmacy does, the hospitals inspect your facility more often and have more stringent standards than PCAB. If you have these more stringent standards to meet, then PCAB would be less desirable. *

    This has a very simple answer. I would ask them for a copy of each of the hospital’s published standards for evaluating compounding pharmacies. You can then compare them to our published standards available at http://www.pcab.org. You can them ask them for a document from the hospitals stating the pharmacy has met whatever formal standards they use. You might also ask them about the qualifications of the hospital staff evaluating their operation. When hospitals outsource to compounding pharmacies it is typically because they do not have the technology, personnel, equipment or expertise to perform the compounding themselves.

    Our Board of Directors includes the United States Pharmacopeia, the American Pharmacists Association, National Home Infusion Association etc., and our standards were developed in collaboration with those organizations. Finally, quite a few hospital systems are now requiring pharmacies they work with to be PCAB accredited.

    *Any compounder can have their medications tested, which of course Lloyd Center and Pacific Compounds both have their compounds tested by an independent laboratory. **This is only common sense for good compounders who want to offer excellent and safe medications to their patients.*

    The PCAB survey process includes a review of whether the pharmacy is performing the correct testing, with correct sampling rates etc. While it might be “common sense”, correct testing is based on science, not common sense. While any pharmacy can perform testing, PCAB finds that the testing program at many pharmacies is inadequate. Our accreditation process requires stringent testing.

    *The reason hospitals don’t look at PCAB is because looking at a facility
    only once every three years is not sufficient for them and the standards
    they expect are higher than the PCAB standards…the hospitals want to do their own inspections as PCAB standards are lesser than hospital standards.”

    As noted above, this is completely incorrect. Many hospital systems require PCAB accreditation, and many more are doing so as a result of current events. Hospitals are all accredited, and those visits occur every three years. When hospitals consider working with a pharmacy, they do often perform on site visits. This is not to say that they do not consider PCAB accreditation valuable, but rather, they are doing their own due diligence to assess whether that pharmacy can meet their needs. I am sure that all of your physicians work with accredited hospitals. Accreditation is just one quality parameter they use to select the hospital they work with. They probably consider the hospitals reputation, services etc., and I am sure they would want to walk in and look for themselves before affiliating. For those hospitals that require PCAB accreditation, I always recommend that they also perform an on-site inspection of their own.

  8. Cory

    I am sure that at some point PCAB, or some other similiar certification, will become required which is probably a good thing. For pharmacies like ours who are already meeting JCAHO standards, it will be a redundancy as Denise points out that JCAHO is the industry standard. I will make only a few comments about the above: to imply that a stellar institution like OHSU doesn’t know what they are doing is both ridiculous and incorrect. I understand that people will say their product is the best out there, etc. but OHSU is an excellent health and research facility that is also home to Oregon State University’s College of Pharmacy. Pharmacy students spend the third year of their studies at OHSU’s Center for Health & Healing in Portland. OHSU brings together education, research, patient care and community service.
    I will repeat myself by saying that we are fortunate to have an excellent compounding community in our area, professionals who are committed to patient safety and good therapeutic outcomes, thanks to great pharmacists like Natalie Gustafson of Lloyd Center and Pacific Compounds Pharmacies and Denise in Wilsonville. We give credit to these pharmacists who work tirelessly to ensure they meet the highest standards possible. They should receive praise for their efforts, not criticism.
    I think the healthcare community works best when we are all supportive of each other in our quest to provide our patients with excellent care in a cooperative, harmonious manner.

    • I didn’t see any criticism nor did anyone imply OHSU isn’t an excellent research facility or hospital. I’m thinking you read in to that. What I’ve read is simply factual and constructive conversation about the importance of quality compounding with good oversight. With the number of compounding pharmacies out there that are out there, patients and doctors need to be informed about the difference. Again, as someone who has visited a dozen or so, there is an enormous difference even though they all meet the state boards of pharmacy requirements. From the differences I’ve seen, I don’t think that is good enough. Certainly not for our patients. Great post Candace and thanks for all who provided feedback. It’s an important conversation to have.

  9. Cory

    I was responding to the following which was previously posted:

    “When hospitals outsource to compounding pharmacies it is typically because they do not have the technology, personnel, equipment or expertise to perform the compounding themselves.”

    I do not think you can make this statement about a great facility like OHSU, which is the facility that we were talking about. As I said, we can, and should, all work together, meeting JCAHO standards or other certifications to provide excellent patient care. I think we all agree that we are striving for the highest standards possible.

  10. candacebwell

    Stephen Beek, Director of Marketing for PCCA (Pharmaceutical Compounding Centers of America) comments below regarding the PCAB issue:
    “We too, believe that PCAB is one way that a pharmacy can follow best practices and document their processes. Although, we also believe that quality is more than just processes, it’s a combination of many things that a pharmacy does, from buying the highest quality, thoroughly tested, active pharmaceutical ingredients available, keeping up with the latest in training and education, having a solid team to back them up with consulting help, to having an ongoing testing regime in place for their compounds.”

  11. Cory

    I agree wholeheartedly with Mr. Beek. Processes alone do not make a great compounding pharmacy. PCCA offers excellent Pharmacist and Technician training, the highest quality active ingredients and a comprehensive consulting staff. Your staff must be knowledgeable and they need to get excellent continuing education to keep up on all the latest medical developments. You also need to have all the latest technologies available, be starting with the purest grade pharmaceutical ingredients and have a worldwide consulting team. PCCA membership offers all these services to compounding pharmacy. Having the highest standards of safety is foremost, but without an excellent team, they do you no good.
    There are many facets to an excellent compounding pharmacy. Just as there are differing levels of testing, there are also large differences in the training and knowledge of staff. Compounding, like any other medical profession, must be a complete and comprehensive package to obtain the best results!

  12. Cory

    Candace, here is a PCAB certified compounding pharmacy that had a SURPRISE inspection by their state board and had to recall all it’s sterile products. This is why I say that PCAB is not the “end all, be all” of compounding….there are many things to look for as Mr Beek with PCCA stated.
    http://www.cbsnews.com/8301-204_162-57576143/mass-compounding-pharmacy-recalls-drugs-after-surprise-investigation/

  13. Cory

    This is the latest PCAB certified pharmacy with recalls….thank goodness for SURPRISE inspections every year by our state boards.

    From their website:

    Pallimed Solutions Pharmacy : Affiliations
    August 25th, 2012 | Author: admin
    Pallimed Solutions is an active member of the pharmaceutical and healthcare industries. We value the relationships that we have built and strive to acquire new partners within our community.

    Below is a list of organizations that Pallimed is affiliated with:

    Pallimed Solutions is now Massachusetts’ largest sterile PCAB Accredited Pharmacy
    PCAB: Pharmacy Compounding Accreditation Board

  14. Cory

    Here are a list of current PCAB certified pharmacies that have received warning letters from the FDA this year for various non-compliance issues. For a complete list, see the FDA website. I am not saying that PCAB isn’t good, I’m just saying that it isn’t everything, you have other certifications which may or may not be better and you have to look at the pharmacy as a whole….not just say that if you have a certain certification then that’s all that matters. Because it isn’t.

    Specialty Compounding
    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM345935.pdf

    Wedgewood
    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM342543.pdf

    Drugs Are Us (Hopewell Pharmacy)
    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM345692.pdf

    Foundation Care
    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM345699.pdf

    Oakdell Pharmacy
    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM342541.pdf

    Triangle Compounding
    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM342540.pdf

    JCB Labs
    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM348229.pdf

    Avella of Deer Valley
    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM34276.pdf

    Anazaohealth Corporation
    http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM341368.pdf

    Talk to your pharmacist…their knowledge is a good indicator. Visit the pharmacy…see what safety measures they employ. Do they bar-code all chemicals? Check the FDA website to see if they have been written up. See what organizations they are in good standing with…check the Pharmacy Board website. But first, talk with your pharmacist…it’s a good place to start.

    • oh for effs sake Cory.. let it go. Careful what you want exposed, you might find your favorite pharmacy on a list. That’s what accountability is all about, would you like a list of non PCAB pharmacies that have been audited and shut down?

  15. candacebwell

    We need consensus, cooperation and collaboration between ALL compounders, PCAB or not, to pool their knowledge and resources in serving their customer, the confused meno or andro pausal patient still sorting their way through the often confusing mazed of safe natural solutions…we need to know the points on which you agree …

  16. I was trying to respond to Candace’s question of how to find a good compounder because it is about the patient and getting them a quality compound. Sterile products from some of the above pharmacies had to be recalled because they had floating particulate in them. So, it may be giving people a false sense of security to say that PCAB is all that matters. I think FDA and state board inspections are more telling because they are surprise inspections, not scheduled inspections like PCAB. I imagine that at some point PCAB or JCAHO will be mandatory in addition to state board and FDA inspections for sterile (and maybe non -sterile) compounding…..but they will need to inspect more frequently and on a surprise basis for it to be the most effective. Talks have been taking place for ideas on how to best ensure patient safety. I think if we all contribute our ideas, we can help shape positive policies that protect a patients access to quality compounded medications.

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