Issue link: https://www.e-digitaleditions.com/i/1067339
References 1. FDA Draft Guidance: Gluten in Drug Products and Associated Label- ing Recommendations Guidance for Industry, December 2017. 2. Medications and Gluten: "What types of ingredients that may contain gluten are in oral drug products? https://www.fda.gov/Drugs/Resources ForYou/Consumers/BuyingUsing MedicineSafely/EnsuringSafeUseof Medicine/ucm410373.htm. 3. CODEX Alimentarius: Standard for Foods for Special Dietary Use for P e r s o n s I n t o l e r a n t t o G l u t e n , CODEX STAN 118-1979. Adopted in 1979. Amendment: 1983 and 2015. Revision: 2008. 4 . F D A T h r e s h o l d W o r k i n g Group Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food: https://www. fda.gov/Food/GuidanceRegulation/ G u i d a n c e D o c u m e n t s R e g u l a t o r y I n f o r m a t i o n / A l l e r g e n s / u c m 1 0 6 108.htm. 5. Ankita V. Shah, Abu T. M. Ser- ajuddin, and Robert A. Mangione. "Making All Medications Gluten Free." Journal of Pharmaceutical Sci- ences. 2018. Vol. 107, No. 5. pages 1,263-1,268. 6. FDA SUPAC-IR "Guidance for Industry: Immediate Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documenta- tion." November 1995. https://www. fda.gov/downloads/drugs/guidances/ ucm070636.pdf. 7. The International Pharmaceuti- cal Excipient Council & The Pharma- ceutical Quality Group The Joint Good Manufacturing Practices Guide for Pharma- ceutical Excipients. 2017. https://www. ipec.org/sites/default/files/files/ 2 0 1 7 0 3 2 3 % 2 0 I P E C - P Q G % 2 0 GMP%20Guide_Final.pdf. 8. NSF/IPEC/ANSI-363. "Good Manufacturing Practices for Pharma- ceutical Excipients." 2016. 9. EXCiPACT. "Certification Standards for Pharmaceutical Excipi- ent Suppliers: Good Manufacturing Practices/Good Distribution Prac- labeling such as "gluten-free" is not beneficial to the consumer. It is often taken advantage of by mar- keting and consumer groups, even when there is no potential for glu- ten to be present ("gluten-free water" for example). This is likely to create an unattainable, zero-tol- erance situation for drug product manufacturers and give consumers the impression that the presence of any gluten is cause for concern, when, in fact, gluten is a health concern only for an extremely small percentage of the population. Furthermore, patients may avoid necessary or beneficial medications due to gluten concerns when there is no significant risk (<20 ppm). D r u g p r o d u c t m a n u f a c t u r e r s have access to information regard- ing the origin of the ingredients used in their formulations, includ- ing the presence of gluten-contain- ing ingredients. Most drug product manufacturers obtain this informa- tion from their suppliers, usually in the form of statements or question- naires. IPEC is updating its Excipi- e n t I n f o r m a t i o n P a c k a g e ( E I P ) Guide [11] to incorporate reference to "gluten statement(s)" in an EIP. I P E C - A m e r i c a s s u p p o r t s t h e FDA's initiative to ensure that drug product manufacturers obtain infor- mation regarding the gluten con- tent of the excipients used in their products. When an excipient con- tains more than a designated level of gluten, the drug product manu- factu rer sh o u ld b e req u ired to obtain information from the sup- plier to determine how the pres- ence of gluten may impact the fin- ished drug product's labeling. T&C tices." 2017. https://www.excipact. o r g / f i l e s / E X C i P A C T / D o w n loads/20180123%20EXC%20Stan dard_Final-webversion.pdf. 1 0 . " T h e I P E C E x c i p i e n t Composition Guide." 2009. (revision currently in progress). http://ipec- europe.org/UPLOADS/IPECCom positionGuidefinal.pdf. 11. "IPEC Excipient Information Package Template and User Guide." 2009. (revision currently in prog- ress). https://ipecamericas.org/sites/ default/files/ExcipientInformation Package2009.pdf. Christopher C. DeMerlis is head of CCD Consulting Services; Luke Gro- choll, PhD, is a regulatory affairs expert at MilliporeSigma; Jeffrey Pitt is lead toxicologist at DuPont Nutrition & Health; Irwin Silverstein, PhD, is head of IBS Consulting in Quality; Stephen M. Tyler is director of quality assur- ance at Abbvie; and Priscilla Zawislak is global regulatory affairs advocacy manager at Dow Chemical. IPEC-Americas (571 814 3449, ipec americas.org) develops, implements, and promotes voluntary science and risk- based guidance for e xcipie nts while e mbracing har monization of drug approvals and pharmacopeial standards. IPEC-Americas is dedi- cated to working closely with regula- tory authorities, industry organiza- tions, and scientific bodies (globally) to advance public health on matters relating to the quality, safety, manu- facture, distribution, use, and function- ality of excipients. Membership is com- prised of a unique partnership between makers, suppliers/distributors, and users of drug components. This part- nership enables drug manufacturers to work with excipient suppliers to develop and promote guidance that facilitates the qualification, manufacture, and supply of excipients. Tablets & Capsules January 2019 45 Not having established limits for the term "gluten-free" is confusing and does a disservice to consumers.