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`
`notices
`
`mammals- (RFD-530).
`Bureaus!”
`'
`Must for Hearing (was with
`Doekstnumbaappearinginthehlading
`ofthisuotice):nuring01erb.1'podand
`gruAdministr-ation (Bro-20),Rm.i~
`Requests for the report of the National
`Academy of Sciences-National Research
`Council: Data Preparation Branch
`(HID-814), Division.oi Drug Informa-
`tion Resowces, Bureau of Drugs.
`Other oommunioaflons regarding this
`notice: Drug Mcacy Study Ihrplcmenta-
`tion Project Hanager (RFD-101), Bu-
`reau of Drugs.
`'
`This notice is issued under the Federal
`Food. Drug. and Genetic Act (secs. 502.
`505. 52 Stat. 1050-1053. as amended (21
`11.8.0. 352. 355)) and under the author-
`ity delegated to the Director of the Sn-
`reau of Duns (21 an 5.31)
`(recodin-
`cation published in the Pruner. Roars-rm
`of June 15, 1976 (41 FR. 24262) ) .
`Dated: August 5, 1976.
`
`loam allowable in labeling. Any such
`product labeled for those mdications. is
`subiecttoregruatoryaction.
`1. NBA 3-1;“:
`cortisone Acetate
`Ophthalmic
`tmcntcontalning 1.5m-
`cent cortisone acetate: The Upidrn 00..
`7171 Portage Rd” Kalamaaoo. MI 49002.
`2. mt par-tof NDA 7-913 pertaining
`to Cartons Acetate Ophthalmic Suspen-
`‘sioucontainingosperoentcofiisoneace-
`tate; McrckflrarphDohme,Divisionof
`Merck g 00.. Inc.. West 'Point..PA 19466.
`3. NDA 9-018; Hydrocortone Ophthal-
`mic Ointrnent containing 1.5 percent
`hydrocortisone acetate and Suspension
`containing 0.5 percent and 2.5 percent
`hydrocortisone acetate; Merck Sharp 5:
`
`J. Brenna Csou'r.
`Director, Bureau of Drugs,
`[F'R Doc.76—2882'I flied 8—12—76:8:45 am]
`
`4. NDA 10-231; Hydrin.2 Ophthalmic
`Suspension containing 2 percent hydro-
`cortisone acetaie' Biker Laboratories,
`Co., 19901 Nordhoif
`St., Northridge, CA 91324.
`‘
`5. NBA 10-645; Optcf Eye Drops con-
`taining 0.2 percent hydrocortisone; The
`Upiohn Co.
`6. NBA 9-136: Cortril Ophthalmic
`Ointment containnig 0.5 percent and 2.5
`[Docket No. 763—0812; m's 7918 and 9180]
`percent hydrocortisone acetate; Pfizer
`Laboratories. Division Pfizer Inc.. 235 E.
`CERTAIN STEROiD PREPARATIONS FOR
`42d St... New York, NY 10017.
`OPHTHALMIC AND/0R 91"": [BE
`7. NBA 9-825: Isopto Hydrocortisone
`Drugs for Human Use: Drug Efficacy Study
`Eye Drops containing 0.5 percent and
`implementation: Followup Notice .end
`2.5 percenthydrocortisonc with hydroxy-
`Opportrmitytorlieadng
`propyl methylcollulose: Alcon Laborator-
`In a notice (DESI 9130; Docket No.
`ies, Inc. 6201 S. Freeway, Box 1959, Ft.
`Worth, Tx 76101.
`'
`F'DC—D-221 (now Docket No. 7611-0312))
`published in the Firm Racism of Au-
`8. NDA 10—039: Hydeltrasol Ophthal-
`mic Solution containing 0.5 percent
`gust 26. 1970 (35 FR 13605), and in a
`prednisolone sodium phosphate; Merck
`subsequent notice (mm 7913; Docket
`Sharp 5: Dohme.
`No. FDC—D-323 (now also Docket No.
`7617-0312)) published in the Finesse
`9. NBA 11—028; Hydeltrasol Ophthal-
`Racism of October 22. 1971 (36 FR.
`mic Ointment containing 0.25 percent
`20451), the Maud Drug Administra-
`prednisolone sodium phosphate; Merck
`Sharp b Dohme.
`tion announced its conclmions that cer-
`10. NDA 13-422; Maxidex Ophthalmic
`tain steroid preparations dcscribedbe-
`low are eflective for the treatment of
`Solution containing 0.1 percent dexa'-
`methasone; Alcon Laboratories, Inc.
`various inflammatory disorders of the
`eye and/or ear. The notices also classi-
`11. RDA 11—984: Decadron Phosphate
`fied the preparations.“ less than eifec-
`Ophthalmic Solution containing 0.1 per-
`cent dcrramethasone sodium phosphate;
`tive (probably eifective. possibly effec-
`Merck Sharp 5: Dohme.
`tive. and lacking suktantial evidence of
`eilectiveness) for certain other indica-
`12. NBA 11—977; Decadron Phosphate
`Ophthalmic Ointment containing 0.05
`tions and provided an opportunity for
`hearing for the indications concluded at
`percent denamethasone sodium phos-
`that time to lack substantial evidence of
`phate; Merck Sharp 8: Dohmc.
`The following drug products were not
`eil’ectiveness. No person submitted data
`included in the August 26, 1970 or the
`in support of the probably or possibly
`October 22. 1971 notices, but the conclu-
`effective indications. and they are now
`reclassified as lacking substantial evi-
`sions described in this notice are appli-
`cable to them.
`’
`dence of eflectiveness. This notice offers
`Acetate
`1. NDA
`9-615;
`Cortct
`an opportunity for hearing concerning
`Ophthalmic and otic Suspension con-
`the probably emotive and possibly exec-
`iive indications, which are now reclassi-
`taining hydmcortisone acetate; The Up-
`iohn Co.
`fied as lacking substantial evidence of
`eifectiveness, and states the conditions
`2. NBA 9-617; Cortef Acetate thhai-
`for marketing the drugs for the indica-
`rnic Ointment containing hydrocortisone
`tionsforwhichtheycontinuetobere-
`acetate; The Upjohn Go.
`sardedasefleetive.Personswhowishto
`3. ThatpartofNDA 10—439pcrtaming
`recast a hearing may do so on or before
`to Isopto BEN. Opthalmic Solution
`September 13, 1976.
`containinghydrocortisoncorhydro-
`The notice that follows does not per-
`mmmmwmmmmtate;AloonLaboratories,
`Inc.
`August25.19700rthe0ctoberz2.1971
`
`corp»
`Kennwerth, NJ 07038.
`5. RDA 9—041:
`1809“ Cortisone
`Ophthalmic
`Suspension
`containing
`fogcrtisons acetate; Alcon laboratories.
`‘ 6. NBA 10-776; Delta Cortef Eye Solu-
`tion containing prednisolone: acetate;
`The Upjohn Co.
`,
`7. That part of NDA 7-013
`to Cor-tone Acetate Ophthalmic Oint-
`ment
`containing
`cortisone
`acetate;
`Merck, Sharp a Dohme.
`‘
`In a notice published in the Peanut.
`Rscrsrsa of October. 27, 1971 (36 FR
`20619), the approval of NDA 7-913 for
`Cortone Acetate Ophthalmic Ointment
`and Suspension was withdrawn on the
`ground of failure to submit required re-
`ports under section 505(1) of the Fed-
`eral Food, Drug, and Cosmetic Act
`(21
`13.8.0. 355(1) ). At the time that notice
`was published, no final conclusions con-
`cerning its less than effective (probably
`eifective) indication had been reached.
`Those
`conclusions have
`now been
`reached, and the purpose of including
`Cortonc (cortisone acetate) Ophthalmic
`Ointment and Suspension in this notice
`is to inform all interested persons of such
`conclusions and ofler them the oppor-
`- tunity to redirect a hearing concerning
`all issues relating to its legal status.
`Such drugs are regarded as new drugs
`(21 U.S.C. 321(p)). supplemental new
`drug applications are required to revise
`the labeling in and to update previously
`approved applications providing for such
`drugs. An approved new, drug application
`is a requirement for marketing such drug
`products.
`In addition to the holder(s) of the new
`drug application(s) specifically named
`above, this notice applies to all persons
`who manufacture or distribute a drug
`product, not the subject of an approved
`new drug application, that is identical.
`related, or similar to a drug product
`named above, as defined in 21 CFR 310.6.
`It is the responsibility of every drug
`manufacturer or distributor to review
`this notice to determine whether it cov-
`ers any drug~ product he manufacturers
`or distributes. Any person may request
`an opinion of the applicability of this
`notice to a specific drug product he
`manufacturers or distributes that may
`be identical. related, or similar to a drug
`product named in this notice by writing
`to the Food and Drug Administration,
`Bureau of Drugs. Division of Drug La-
`beling Compliance
`(HFDSIO),
`5600
`Fishers Lane, Rockville, MD 20852.
`A. Eflectlveness classification. The
`Food and Drug Administration has re-
`viewed all available evidcncc and con-
`cludes that the drugs are eflective for
`the indications listed in the labeling con-
`ditions below. The drugs now lack sub-
`stantial evidence of effectiveness for the
`indications evaluated as probably or pos-
`sibly eifective in the August 26. 1970 and
`the October 22. 1971 notices. The prob—
`ably edective indications in the Och-
`ber 22, 1971 notice included the otic in-
`
`m m VOL 41, NO. ISHIIDAY, ANGUS! I3, 1976
`
`APOTEX1026. pg. 1
`
`APOTEX 1026, pg. 1
`
`

`

`/
`
`NOUCES
`
`-
`
`34341
`
`dication her dexamelhasone sodium
`phosphate 0.05 percent. This 0.05 per-
`cent strength ed dexamethasone sodium
`phosphate now lacks nrhstantisl evi-
`genes of effectiveness rm otic indica-
`on.
`B. Conditions for approval and mar-
`keting. The Food and Drug Administra-
`tion is prepamd to approve abbreviated
`new drug applications and abbreviated
`supplements to previously approved new
`drug applications under conditions de-
`scribed herein, except that abbreviated
`applications are not appropriate for hy-
`drocortisone preparations for otic use
`containing less than 0.5 percent hydro-
`cortisone since such low strengths have
`not been shown to be effective for that
`route of administration. The manufac-
`turer's labeling for the product described
`in this notice that contains 13.2 percent
`hydrooortisone does not
`recommend
`the product for otic use.
`.
`1. Form of drug. The drugs-are in oint-
`ment. aqueous solution, or aqueous sus-
`pension forma formulated to be suitable
`for the intended route of administration.
`Dosage forms for ophthalmic use shall be
`sterile.
`2. Labeling conditions. a. The label
`bears the statement, “Caution: Federal
`law prohibits dispensing without pre-
`scription." Labels for ophthalmic prep-
`arations state that the preparation is
`sterile.
`b. The drug is labeled to comply with
`all requirements of the act and regula-
`tions. and the labeling bears adequate
`information for safe and effective use
`
`of the drug. The Indications are as fol-
`lows:
`Orrrrrrsunc
`
`Steroid responsive inflammatory con-
`ditions of the palpebnal and bulbar con-
`junctiva. cornea, and anterior segment
`of the globe. such as allergic conjunc-
`tivitis, acne rosacea, superficial punctate
`keratitis. herpes roster keratitis. iritis,
`cyclitis. selected infective conjunctivitis
`when the inherent hazard of steroid use
`is accepted to obtain an advisable dimi-
`nution in edema and inflammation:
`corneal inJury for chemical or thermal
`burns, or penetration of foreign bodies.
`One
`
`(For all except the 0.05 percent dex-
`amethasone sodium phosphate)
`steroid responsive inflammatory con—
`ditions of the external auditory meatus.
`such as allergic otitis externa. selected
`purulent and nonpurulent infective otitis
`externa when the hazard of steroid use
`is accepted to obtain an advisable dimi-
`nution in edema and inflammation.-
`3. Marketing status. a. Marketing of
`drug products that are now the subiect
`of an approved or eifective new drug ap-
`plication may be continued provided
`that. on or before October 12, 1976, the
`holder of the application submits. if he
`has not previously done so. (i) a sup-
`plement for revised labeling as needed to
`be in accord with the labeling condi-
`tions described in this notice. and com-
`plete container labeling if current con-
`tainer labeling has not been submitted,
`\
`
`and (ii) asupplement toprovide updat-
`ing information with respect to items 0
`(components), 7 (composition), and 8
`(methods, facilities, and controls) of new
`drug’application form I’D-3583 (21 CPR
`314.1(c)) to the extent required in ab-
`breviated applications
`(21 cm 314.1
`(1)).
`b. Approval of an abbreviated new
`drug application (21 cm 314.1(f)) must
`be obtained prior, to marketing such
`product. Marketing prior to approval of
`a new drug application will subject such
`products. and those persons who caused
`the products to be marketed, to regula-
`tory action. .
`‘
`-
`C. Notice of opportunity for hearing.
`On the basis of all the data and infor-
`mation available to him,
`the Director
`of the Bureau of Drugs is unaware of
`am) adequate and well~controlled clinical
`investigation,
`conducted
`by
`experts
`qualified by scientific training and ex-
`perience. meeting\the requirements of
`section 505 of the Federal Food. Drug.
`and Cosmetic Act
`(21 13.3.0. 355) and
`21 CPR 314.111(a) (5). demonstrating
`the eflectiveness of the drug(s) for the
`indicationis)
`lacking substantial evi-
`dence of eifectivenees referred to in par-
`agraph A. of this notice.
`Notice is given to the holder(s) of the
`new drug applicatioms) . and to all other
`interested persons, that the Director of
`the Bureau of Drugs proposes to issue
`an order under section 505(c) of the
`Federal Food. Drug, and Cosmetic Act
`( 21 {1.8.0. 355(e) ). withdrawing approval
`of the new drug application(s)
`(or, if
`indicated above, those parts of the appli-
`cation(s) providing for the drug prod-
`uct(s) listed above) and all amendments
`and supplements thereto providing for
`the indicatioms) lacking/substantial evi-
`dence of effectiveness referred to in para-
`graph A. of this notice on the ground
`that new information before him with
`respect to the drug product(s). evalu-
`ated together with the evidence available
`to him at the time of approval of the
`application(s). shows there is a lack of
`substantial evidence that the drug prod-
`uct(s) will have all the effects it pur-
`ports or is represented to have under the
`conditions of use prescribed.
`recom-
`mended, or suggested in the labeling. An
`order withdrawing approval will not issue
`with respect to any application(s) sup-
`plemented.
`in accord with this notice.
`to delete the ciaim(s) lacking substantial
`evidence of eii’ectiveness.
`In addition to the ground for the
`proposed withdrawal of approval stated
`above.
`this notice of opportunity for
`hearing encompasses all issues relating
`to the legal status of thexdrug products
`subject to it
`(including identical, re-
`lated, or similar drug products as defined
`in 21 CFR 310.6), e.g., any contentiorr
`that any such product is not a new drug
`because it is generally recognized as safe
`and eifectivewithin the meaning of sec-
`tion 201(1)) of the act or because it is
`exempt from part or all of the new drug
`provisions of the act pursuant to the
`exemption for products marketed prior
`to June 25. 1938, contained in section
`
`,
`
`/
`
`201(p) of the act. or pursuant to section
`107(c) of theDrugAmendments of 1902:
`orforanyotherreason.
`In accordance with the provisions of
`section 505 of the act (21 0.8.0. 355) and
`the regulations promulgated theretmder
`(21 CFR Parts 310. 314) , the applicant(s)
`and all other persons who manufacture
`or distribute a drug product which is
`identical, related, or similar to a drug
`product named above (21 on 310.8).
`are hereby given an opportunity for a
`hearing to show why approval of the
`new drug applicationis) providing for
`the ciaim(s)
`involved should not be
`withdrawn and an opportunity to raise.
`for administrative determination. all is-
`sues relating to the legal status of a
`drug product named above and all iden-
`tical. related. or similar drug products.
`If an applicant or any person subject
`to this notice pursuant to 21 CPR 310.6
`elects to avail himself of the opportu-
`nity for a hearing, he shall file ( 1) on or
`before September 13, 1976. a written no-
`tice of appearance and reqth for hear-
`ing. and (2) on or before October 12,
`1976. the data, information, and analyses
`on which he relies to justify a hearing.
`as specified in 21 CFR 314.200. Any other
`interested person may also submit com—
`ments on this proposal to withdraw ap—
`proval. The procedures and requirements
`governing this notice of opportunity for
`hearing, a notice of appearance and re-
`quest for hearing, a submission of data.
`information. and analyses to justify a
`hearing. other comments, and a grant or-
`denial of hearing, are contained in 21
`CFR 314.200.
`The failure of an applicant or any
`other person subject to this notice pm;-
`suant to 21 CPR 310.8 to file timely writ-
`ten appearance and request for hearing
`as required by 21 CFR 314.200 constitutes
`an election by such person not to avail
`himself of the opportunity for a hearing
`concerning the action proposed with
`respect
`to such drug product anti a
`waiVer of any contentions concerning the
`legal status of such drug product. Any
`such drug product labeled for the indica-
`tion(s) lacking substantial evidence of
`effectiveness referred to in paragraph A.
`of this notice may not thereafter law-
`fully be marketed. and the Food and
`Drug Administration will
`initiate ap-
`propriate regulatory action to remove
`such drug products from the market.
`Any new drug product marketed without
`an approved NDA is subject to regulatory
`action at any time.
`A request for a hearing may not rest
`upon mere allegations or denials. but
`must set forth specific facts showing that
`there is a genuine and substantial issue
`of fact that requires a hearing. If it con-
`clusively appears from the face of the
`data. information. and factual analyss
`in the request for the h
`that there
`is no genuine and substantial issue of
`fact which precludes the withdrawal of
`approval of the application. or when a
`request for hearing is not made in the
`required format or with therequired
`analyses.
`the Commissioner will enter
`
`summary Judgment against the pcrson(s) .
`
`APOTEX 1026. pg. 2
`
`FEDERAL REGISTER, VOL. 41, NO.
`
`ISO—FRIDAY, AUGUST 13, I976
`
`APOTEX 1026, pg. 2
`
`

`

`_
`Honors
`others mast-Wm the m-
`
`..
`and Drushhsuingthisnotios) r‘,
`'mousm a .mmm*~ '
`
`Consume Paooocr Bin-n Commission '
`Ann T!!!
`r Foot) m Dana Anxmxsrurron .
`
`moon of-the term “food" inrsecuon 201
`.(r) or drama Act (21 11.6.6. 821(1)) is,
`thereby; critical in delineaflng the
`scope orcrsc'.s. Jurisdiction orsr "con-
`stmier products”:
`'
`‘
`The term “food" means (1) articles
`usedforfoodordrinki’ormanorother
`annuals. (2) chewing gum. and (3) ar-
`ticles outlier-components of any such
`
`of‘this "Memorandum in
`The p
`is to delineate‘the
`Unders
`of iurisdiction of therapectve'signa-
`tories for ethninistration of the Con-
`eumerProductflafetyActandtheled-
`_/eral Food. Drug. and Cosmetic'Act with
`respect to food.” food containers. and
`food-related articles and equipment.
`mu. nucleons
`
`' B-J'DA Responsibilities. Thel'bod and
`Drug Administration (IDA) of the; De-
`
`amonrother things.
`into interstate
`commerceofarticiesoffoodthatare
`adulteraied or misbranded. An “adul-
`terated food". as described in section 402
`(21 [1.8.0. 342).. is one which. because of
`its contents is, among other things. in-
`jurious to. health or otherwise unfit for
`food. A “misbranded food", under sec-
`tion 403‘s: the Act (21 0.8.0. 343). is one
`which. among other thing). is false or
`misleading in any particular of its label-
`ing.Tbepurposeofthel'DCActisto
`ensure that foods are wholesome. safe to
`eat. produced under sanitary conditions,
`and labeled and packaged in a truthful,
`informative, and.nondeceptive manner.
`Under the FDC Act, FDA is also respon-
`sible for ensuring that “food additives",
`as defined in section 201(s)
`(21 use.
`321(5)), are safe under the conditions
`of their intended use.
`m FOR CWUICAI’ION
`
`, f The need for. this Memorandum of
`Understanding arose because. of uncer-
`tainty concerning the scope of the statu-
`tory exclusion lmder the CPBA for all
`articles defined asd‘iood" by the FDC
`Act. The need fer clarification is acute
`because determination of whether a po-
`tentially hazardous consumer article is a
`“food" determines as well whether con-
`sumers are to be protected from risk of
`injury orillnessby CPSCpursuanttothe
`CPSA or by PDApursuant to the FDC
`Act. Congress recognized the need for
`cooperation between CPBC and other
`federal agencies when, in section 29(c)
`of~the CPBA (15 17.8.0. 2078(c) ). it pro—
`vided that the Commission and the heads
`of other demerits and agencies en-
`gaged in administering programs related
`to product safety shall, to the maximum
`extent practicable, cooperate and consult
`in order to‘insure fully coordinated
`efforts.
`’
`
`While this Memorandum addresses the
`significant food-related Jurisdictional is-
`sues encountered since enactment of the
`creamsstmtis recognizedbrthetwo
`agencies that additional points needing
`clarification may arise in the future and
`.thatchangesinthisagreementmay be-
`
`new
`
`Supplemaits (identify with NDA num-
`ber): Division of Anti-Infective Drug
`Products (RFD-140.), Rm. 123-45, Bu-
`reau of Dmgs.
`Original abbreviated new drug appli-
`cations (identify as such): Division of
`Gena-lo Drug Monographs (RFD-530).
`Bureau of Drugs.
`Request for Hearing (identify with
`Docket number appearing in the head-
`ing of this notice): Hearing Clerk, Food
`211:5Drug Administratim (BIC-20) , Rm.
`Requests for the report of the National
`Academy of-Bciences-National Research
`Council: Data . Preparation Branch
`(ED-614), Division of Drug Informa-’
`tion Business, Bureau of Drugs.
`Other communications regarding this
`notice:- Drug Efficacy Study. Implementa-
`tion Project Manager (RFD-101) . Bureau
`of Drugs.
`’
`_
`, This notice is issued under the Federal
`l'bod. Drug. and Cosmetic Act (secs. 502.
`505. 52 Stat. 1050—1053, as amended (21
`UB.C. 352. 855) ) and under the authority
`delegated to the Director of the Bureau
`of'Drugs (21 CPR 5.81)
`(recodincation
`publhhed in the Penna. chxsrrn of June
`15. 1976 (41 FR 24262) ).
`\ Dated: August 5. ms.
`t
`J. chnnn Cnour,
`y"
`Director, Bureau of Drugs.
`[PB WHO—28828 Filed 842-76335 am)
`
`rI
`
`[EA—2254184003 I
`
`soon rooo counts
`mo rooo
`asthma mars 1335'EQUIPMENT-
`4 Wamdumeundingm_
`
`_{
`
`L
`
`announcing that a Memorandum of
`Understanding has been executed with
`the ConnnnC‘.Product,'.8afety Commu-
`siononJu‘lyzo. 1976.1’hepurposeofthe
`memorandum is to delineate areas of
`Jurisdiction in, the administration of the
`consumer Product Safety Act and the
`www.deouneticAct_
`with mt tofood. food containers.
`andfooderslaiedarticlesandeouipment.
`Punuanttotheiannomunmt.»
`lithed in the mm; Rams of Ce-
`taber8.1974_(2sifRW) dietitians
`
`theioodand'DIugAdministr-aticnand
`
`A. CPSC Responsibilities. The Con-
`sunier Product Safety Commission
`(CPSC)
`administers
`the Consumer
`Product Safety 'Act (CPSA)
`(15 U.8.C.
`2051 et seq.) . which was enacted to pro-
`tect the public from lmreasonable risks
`of
`injury_ associated with" consumer
`products. In order to accomplish its
`mission the Commission is authorized.
`among other things to issue consumer
`product safety standards, to establish re-
`quirements for warnings and instruc-
`tions.
`to declare consumer products
`banned hazardous products when the
`public cannot be protected adequately by
`feasible consumer product safety stand-
`ards, and to require manufacturers. dis-
`tributors. and retailers to report poten-
`tial substantial product innards associ-
`ated with consumer products to the
`Commission, and after opportunity for
`a hearing, to give noticehand/or repair,
`replace. or refund the purchase price of
`the consumer product found to present
`a substantial product hazard.
`The term “consumer product" is de-
`fined in section 3(a) (1) of the CPSA (15
`13.8.0. 2052(a) ( 1)) as follows:
`The term “consumer product” means
`any article, or component part thereof.
`produced or distributed (1) for sale to a
`consmnerforuseinorarotmdapennas
`cent or temporary-household or resi-
`dence. a school. in recreation, or other-
`wise, or (ii) for “the personal use,'con-
`sumption or eniorment of a consumer in
`or around ‘a permanent or temporary
`htmsehold or residence, a school. in rec-
`reation. or otherwise; but such term does
`‘ not include-9 " ""
`(1) food. The term “food" as used in
`this subparagraph means all "food", as
`defined in section 201(1) of the Federal
`ma. Drug, andCOsmetic Act, 3 ' ‘ '
`Thus. articlesW's: "food”.under
`the Federal Pood..Drug, andCosmetic
`Act (roe Act)
`(or ascent et 'seq.)
`are not “commerproducte” "and cannot .
`be undated-under the.\CP8A.‘ The de-
`
`1Substances which are "foods" subleot‘ to
`thomoutueals'o'exeludsdfrommdsa-
`nition ol' "hanrdous substance” under esc-
`tlon 2(1)! 0! the mu We Bub-
`
`under
`.
`regulated
`orecsnnot'
`Act. however-{under section 2(2) (0) of the
`
`CPSC and FDA have agreed upon the
`following principles:
`
`Poison Prevention Packaging Aotof 107d (15
`"0.8.0. 1471 i2) (0) ).‘-‘food" may be made subs
`Jest by 02mm a child-resistant (special).
`packaging requirement.
`.
`
`"OHM “Glmlt VOL 4|, NO. ISHIIDAY, A0005! IS. 1976
`
`APOTEX 1026. pg. ‘3 -
`
`APOTEX 1026, pg. 3
`
`