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Determining the GF status of a Drug

There have been several recent postings regaining the determining the GF
status of specific drugs, both prescription and non-prescription, or of
drugs in general, as well as a request for information on the best means to
proceed. This post is an attempt to provide clear, meaningful information
in the subject.
As background, I was diagnosed with celiac disease in 1998. I am a
veterinarian who has managed allergic patients, and I currently work for an
animal pharmaceutical company. My responsibilities include oversight of the
FDA regulated aspects of the manufacture of our products. These
requirements mirror those for human pharmaceuticals. I have successfully
used my knowledge to ferret out information on the GF status of drugs, but
you can use the same strategy to determine dairy free, egg, free, casein,
free, etc status.
Without further ado…some points to consider:
1. In these days of generics and HMOs, it is critical to know the
manufacturer of the drug you are going to take. While the vast majority of
generics are identical to the branded (pioneer) drug, it is possible for a
generics house to be granted a waiver and make minor (to them, not
necessarily to us) changes to the inactive portions of a drug product.
2. Get a Physician’s Desk Reference (PDR). They can be ordered from
PDR, P) Box 10689, Des Moines, IA 50336, or at www.pdr.net. The PDR
contains the labels for all FDA approved drugs, which are updated once a
year. A company may change labeling more often, but the components usually
don’t vary that often once a drug is approved – it requires a major reason
to change, as it is very expensive to do so. Labels for most recently
approved drugs will list the inactive ingredients, generally in the
beginning sections near the molecular diagram. If nothing else, the PDR
contains the addresses and contact information for all manufacturers of FDA
approved drugs at the front of the book. There are also PDRs for non-
prescription drugs and dietary supplements, Herbal Medicines, Nutritional
Supplements, and Ophthalmic medicines.
3. For those of you who have considered buying drugs outside the US to
save money, do not assume that a product sold in another country is
identical to that sold in the US, even if it is the sold under the same
brand name by the same company. Local regulatory requirements may allow or
require substitutions to the inactive ingredients.
4. Every pharmacy has a PDR. If your pharmacist won’t look a drug up
for you, claims he or she doesn’t have a PDR, or gives you a hard time
about determining GF status, find a new Pharmacist – that one is a
discredit to the vast majority of pharmacists, who are highly trained,
knowledgeable and compassionate professionals.
5. For purposes of pharmaceutical manufacturing the National Formulary
(NF) defines “starch” and “pregelatinized starch” as derived from corn,
wheat, potatoes or tapioca. Topical starch is only derived from corn.
Purified starch or purified soluble starch are derived from potatoes. If a
component has multiple sources the company can switch back and forth
without having to change the labeling. Food component definitions are set
out in the code of federal regulations (CFR) in 21 CFR 184. You can search
the Code of Federal Regulations at
http://www.access.gpo.gov/nara/cfr/index.html.
6. If you call a company to determine the GF status of their drug, the
Customer Service rep will probably need to transfer you or contact someone
in the technical or manufacturing groups. Proprietary information may
prohibit them from giving you a complete drug composition list but they can
check internally and get back to you to determine GF status. Be aware that
many companies now use third party contract manufacturers, and reaching the
right person to answer the question may take a couple of days, so plan
ahead if at all possible. Most Customer Service reps genuinely want to
help; just give them a chance. Be prepared to define gluten as derived from
wheat, etc. and mention dusting of belts and trays, although that is an
uncommon practice in pharmaceutical manufacturing.
7. While most drugs have the same ingredients in the same proportion
for every size, an occasional drug may differ from size to size. Don’t be
put off if you learn that you can take one size of tablet, but not another
Just make sure that the pharmacy doesn’t switch you to the wrong size
tablet.  Remember too that different dosage forms have different
ingredients  - if the capsule is GF, the tablet might not be.
8. Once you determine that a particular drug made by a particular
company is safe, you can have your doctor list a brand name or generic
company name on the prescription. Be sure he or she also initials the DAW
(dispense as written) line so that the pharmacy knows not to make
substitutions. Then check them when you pick up the prescription.
9. As we do with foods, it is good to check regularly (once a year is
probably enough) to be sure that a brand is still GF. Call a company
immediately if the appearance of the drug has changed since the last time
you had your prescription refilled (a good idea in general for any
chronically administered drug, not just for purposes of confirming GF
status).
10. This one is just FYI: Stokes Pharmacy has GF compounding
experience. I have not needed to have a medicine made up in a GF
formulation for myself, but they made special preparations for my patients
when I was in practice. I have spoken with their representatives about
celiac disease and have found them knowledgeable and helpful. I have no
financial interest in Stokes, just wanted to pass along a potential
resource. Their phone number is 1-800-754-5222 and their website is
http://www.stokesrx.com/welcome.html.  The website even contains a section
on celiac sprue.

I hope this answers some questions. If anyone has specific questions about
the steps I’ve outlined, please feel free to drop me an email. I do not
keep a running list of GF drugs to share, but I’ll be happy to walk you
through the steps of finding out for yourself the first time.

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