Monday, December 28, 2015

Gluten in Medications

Handful of pills www.drjeanlayton.com
As a physician who diagnoses celiacs frequently, there is a sequence of cautions I give whenever we have our laboratory review and initial diagnosis. 

I caution about exposures to Wheat, Rye, Barley and conventional Oats.
I caution about topical products ranging from lip balm/lipstick to lotions and hair care products.
I caution about how to eat safely while eating out.
And I caution about medications.
This is the one place where I have to defer to the pharmacists to assist a newly diagnosed patient.
There are many medications that have a wheat, rye or barley component. 
The biggest problem is that there doesn't have to be any labeling of gluten components in medications.
So my colleagues have to contact the manufacturers to find out which do and which don't contain gluten.
Do you think that there is time for that in the rapid preparation of medications?
Not so much.
And that means that frequently, my patients have no guidance for this important aspect of their care.
Now, we have a possibility for help

H. R. 3648

IN THE HOUSE OF REPRESENTATIVES
September 29, 2015
Mr. Ryan of Ohio (for himself and Mrs. Lowey) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL
To amend the Federal Food, Drug, and Cosmetic Act to require the label of drugs intended for human use to contain a parenthetical statement identifying the source of any ingredient constituting or derived from a grain or starch-containing ingredient.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.

This Act may be cited as the “Gluten in Medicine Disclosure Act of 2015”.

SEC. 2. LABELING OF SOURCE OF HUMAN DRUG INGREDIENTS CONSTITUTING OR DERIVED FROM A GRAIN OR STARCH-CONTAINING INGREDIENT.

(a) Misbranding.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:


“(dd) If it is a drug—

“(1) that is intended for human use;

“(2) that contains an ingredient (other than a polyol) that constitutes or is derived from a grain or starch-containing ingredient; and

“(3) whose label fails to include a parenthetical statement identifying the source of the ingredient so constituted or derived.”.

(b) Applicability.—Section 502(dd) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section, shall apply beginning on the sooner of—

(1) a date to be determined by the Secretary of Health and Human Services; and

(2) the date that is 2 years after the date of the enactment of this Act.

If you would like to have this guidance, please reach out to your Congressmen and Senators to let them know that you are eager to have this labeling.

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