Document qmadDqV1170OvYjNB8GRLY7aG

. - A F< 'V A iCAL MA NU LA A /! l/J y A / A yv K s/ S // / ' / / D ecem ber 27, 1973 Hearing Clerk Department of Health, Education & Welfare Room 6-88 5600 Fishers Lane Rockville, Maryland 20852 Subject: Comments on Proposal entitled "Asbestos Particles in Food and Drugs" Appearing in the Federal R egister of Septem ber 28, 1973 (38 FR 27076 ) Dear Sir: n o n - p r o f it TmheemPbhear rsmh iapc eaustsioccaila tMioann ucfoamc tpuorseerds oAf s1s1o0cci aotmi opna nisie sa venogluangteadryi,n the development and production of prescription and ethically promoted overthe-counter drugs. These com panies account for approxim ately 95% of such products made and sold in the United States. Some manufacturing processes tehmeps elo yper do cbeys soeusr wmilelmbbee rsufbijremc st tuotialnizye fainsable sotrodse rf igl toevres rnainndg ttahlce iranudset h. e r e f o r e In General C o m m i s s i oInn etrherepcroeganmizbel es tohfattheit sius bnjoetc tp po rsos ipbolsea lt,o ietliims isntaattee daltlhasto uthrec e s of raesabseosntoasb lceotnotarcetqwu iitrhe fporoedc aauntdi odnrsu gtso. beHtoawk eenv eirn, thite ims acnounfcalucdt uerde thofatfoitodisand drugs to assure that the amount of asbestos fibers is reduced to the minimum fbtheeea srbiebocluoengdnlseivzoeefld.atnhWaaltye triaecgdarulecetteiocwhninthionlsoaugscybheasantdocsocnupcralruretsniicotlnegsoboumdt umbsetalnibeuevfeaacctthcuoartminipgt lispshrhoaeucdltdiwcaeitlshsoin and further that any change in regulatory requirements must be accompanied banydantecahdneiqquuaetse. tim e p e r io d for d e v e lo p m e n t and i m p le m e n ta tio n of new p r o c e d u r e s r)5~P<'ip ( ropresentinc m anufacturers o f prescription pharm aceutical 2- Production and Control P ro c e d u res - Section 133. 8 We are in agreement with the goal to prevent any unnecessary exposure to a potential hazard but we are unaware of evidence that asbestos fibers in quantities purported to be present in some parenterally administered drug products have ever been the cause of adverse effects in human recipients, although asbestos has been a component of m aterials used in processing these pd rrua cgtsi cfaolr mmeatnhyo dd etoc addeems .o nIsnt raadt edittihoen,p rwe see na rcee aodrvaisbesde ntcheat otfh aesr eb eisstonso ianc c e p te d parenteral drugs. of m e m b r a Tn ehef iplhteyrssicaanldcihna rsauccthe riinssttiacnsc eosf md raungy md raungu fparcotduurcetrss phearvme iitmtphlee museen te d appropriate procedures. Many products, however, particularly biologicals, cannot be filtered through membranes. Asbestos-containing filters have been used in the manufacture of biological products for many years. The advantages of such use include basic effectiveness as filters as well as reported depyogenizing effects and adsorption of undesirable components including active viral particles in the manufacture of tissue culture vaccines. Products such as Immune Serum Globulin (Human), Tetanus Immune Globulin (Human) and Normal Serum Albumin (Human) cannot be filtered through membranes at temperatures req u ired to p reven t possible developm ent of pyrogens. Subsection 133. 8(j) of the proposal would prohibit the use of an asbestos-containing filter without subsequent use of an additional non-asbestos-containing m embrane filter unless proof is submitted that the use of a non-asbestos-containing m em brane filter would com pr erqo umiirseed tphreo osfa ftehtayt othr eeuffseec toifv ennoens-sa sobfetshteo sd-rcuogn.t a iInni nthge mceams eb roafnme afniyl tebriso lwo gililca ls, com promise the safety or potency of these products is not available and would require considerable time to ascertain. Imposition of such a requirem ent in any final regulation would seriously ham per the continued production of many bio logicals necessary for the maintenance of the public health. Additionally, subsection 133. 8(j) is ambiguous. The heading of the tshueb sfei rcstitosne nisteenncteitloefdth"eU sseu bopfaar as gb reaspt ohsm- caoknetsa irneifnegr-efni lctee rtso. "theDteesrpmite" tfhi litse rtist"le, without qualification and the second sentence refers to "fiber-releasing filters" without qualification. As written, the paragraph is not clear as to whether it idsruign teinngdreedd iteonetslimo riniafteit arlelf ef irbse ro-nrleyl etoa sai snbge sftiol tse rfsilitne rtsh.e m a n u f a c t u r e of p a r e n t a l 4 * - . . -3 and r e p u b liIsnhveidewasofa tphreo paobos avle sfoa ctthoarts ,i nwt eer essutgegdeps ta rtthiaets twheills ekcntoiown wbhee tchlaerrifiite d relates only to asbestos-containing filters or to non-asbestos fiber-releasing filters as well. Additionally, the modified proposal should contain provisions for the use of asbestos filters without the requirem ent for "proof" that inclusion of a m em brane filter will com prom ise the safety or efficacy of the drug. T a lc - S ection 121. 2006 t e s t p r o c e dSuervee rparlo poof soeudr imn etmhibs esre cf itiromns toh adveet einr md iicnaetepdr ethsaetn cthee omf iacsrboessctoopsi cin talc is inadequate, inaccurate, and time consuming. In some instances, mm iecmr obsecro fpiircmtse sstupb rmoicteteddu rseu gwgheislteioinnsofthoer rmcoadsiefsic anteiwo nmoefththoed sp rwees reen tsupbrompiottseedd. wWee hbaevleie veen ctlhoaste dthtehseemmwe tihtho dtshisansdumb mo disifsiicoantiaonnds hsahvoeuldde bs ieg nstauteddiedth eanmd atsh e r e f o r e , E x hib its A, B, and C. Since it is obvious that differences of opinion exist concerning proposed test procedures and their applicability and feasibility, we suggest that promulga tion of any final regulation be postponed until the state of the art is ascertained and all scientific opinions can be studied. We suggest that FDA establish a working committee with industry and other interested parties to study asbestos content in parenteral solutions and talc and that such a committee make recom m en dations for appropriate test procedures that will effectively m easure the presence oafblaes bsecsieton sti.ficWpiethr s or ensnpeel ctto toa stshiisst sinu gtgheestdioe vne, lowpemaernet wofilalinnyg tteos tcmo nettahcotdkonloogwyl.e d g e We hope these com ments will be of assistance to you. Respectfully submitted, Enclosures. C. Joseph S tetler