DISCLAIMER
The information contained herein is to be used for educational purposes only.
The author is not a medical professional, and this information should not be
considered medical advice. This information should NOT be used to replace
consultation with or treatment by a trained medical professional. The listing
of a medication herein does not imply endorsement by the author.
What is a compounding pharmacy?
How might compounding benefit me with regard
to testosterone therapy?
Is compounding safe?
Are compounded drugs covered by insurance?
Where can I find a compounding pharmacy?
What is a compounding pharmacy?
A compounding pharmacy is a special kind of pharmacy that specializes in
the preparation of medications by mixing raw ingredients. Until the advent of
mass drug manufacturing in the 1950s, compounding was the way virtually all pharmacists
practiced. In the 1930s and 1940s, approximately 60% of all medications were
compounded, as opposed to about 1% today.
Today, compounding pharmacies specialize mainly in the preparation of medicines that are customized to meet the needs of specific patients. This includes preparing medicines for patients who have allergies to certain ingredients found in mass-produced drugs; liquid versions of solid medicines to make them easier to swallow; flavored medicines for children; cream or gel-based versions of a medication for topical application (as well as other delivery methods); medicines that have been discontinued by a manufacturer; or medicines of a different dosage or concentration than that which is typically available. Compounding pharmacies allow for more flexibility, options, and customization than are typically available from pharmaceutical companies.
How might compounding benefit me with regard to testosterone
therapy?
Some individuals might find that they respond well to a prescription of
Delatestryl (injectable testosterone enanthate), but that they experience an
allergic reaction to the sesame oil in which it is suspended. A compounding
pharmacy can suspend testosterone enanthate in a different oil to help avoid
such an allergic reaction. Testosterone topical creams (as opposed to the widely available alcohol-based gels that are mass-produced by pharmaceutical companies) can also be mixed by compounding pharmacies as specified by your doctor's prescription.
Compounding pharmacies can also create sublingual testosterone formulations
or other modified delivery systems according to your specific needs.
As with anything related to your health care, discuss your prescription options with your doctor and pharmacist to find out if the compounding option is right for you.
Is compounding safe?
The U.S. Food and Drug Administration (FDA) has stated that compounded prescriptions are ethical and legal
as long as they are prescribed by a licensed practitioner for a specific patient
and are compounded by a licensed pharmacist. The bulk drug substances used in
a compounded medicine must qualify for use in compounding either via FDA-approved
lists or via a listing in the U.S. Pharmacopoeia National Formulary (USP/NF),
published by an independent standard-setting organization. Previously marketed
drugs that have been found to be unsafe or ineffective and have been removed
from the market may not be compounded.
Because compounding pharmacies mix ingredients in small batches in-house, there has been some inquiry as to whether compounded medicines are as safe as their pharmaceutical company counterparts. Pharmaceutical companies are regulated by the FDA and must meet strict facility and quality control standards to ensure that their products are safe and that each batch is consistent. Compounding pharmacies are regulated by state boards of pharmacy; thus, each state will have a different set of standards.
In general, the quality control and regulation of pharmaceutical manufacturers is better than that of compounding pharmacies. Of course, it is important to keep in mind that many compounding pharmacies are very responsible regarding quality control practices and laboratory technique, and the medicines produced in those facilities can be quite safe. However, for the consumer, safety and purity are of special consideration when obtaining prescription drugs such as injectables.
When choosing a compounding pharmacy, you may wish to inquire about the specific standards, testing, raw materials, and quality control practices that the pharmacy uses to ensure the safety and quality of their medications.
Are compounded drugs covered by insurance?
Unlike manufactured drug products, compounded medications are exempt by
law from having National Drug Code ID numbers. Because of this, some insurance
companies will not directly reimburse compounding pharmacists. However, many
insurance plans allow patients to send in claim forms for reimbursement. Check
with your insurance plan, and ask your compounding pharmacist to provide you
with a universal claim form.
Where can I find a compounding pharmacy?
The International Academy of Compounding Pharmacists (IACP) maintains a
referral service on their web site: www.iacprx.org.
They can also be reached by telephone at 800-927-4227.
A number of trans men have recommended the following compounding pharmacies for
mail-order of testosterone:
Apothecure pharmacy (www.apothecure.com)
Strohecker's pharmacy (www.stroheckersrx.com)
Back to "Testosterone Types and Delivery"
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