Document dYjp0V9r537b3bL1zBykYgKnB

303 it ^ y I Upv/9^V I Wawd TMs Mction * * FEDERAL REGISTER eonUWi* notico* to ttio eubltc of tho propotW Mtuonc* of ratoa *md fofolotton*. Th* purpOM of thtw notice* i* to Jv* intonstotf poraom an opportunity to porticipata In th* nrt*mkSn* prior to to* adaption of tho Rnal ndofc department of labor of films, laminates, papers, and foils pre Use product after It has been dispensed ecupationol Safety and Health Administration sent new problems to the pharmacist In to the patient. The Commissioner Is of dispensing a drug product because of the the opinion that the manufacturer of different properties of these materials. the drug product is the person most able [29 CFR Part 1910) Many drug products are subject to de to supply the necessary information as IDocitot Ko. OBH-SSI <VttITL CHLORIgf^ composition or deterioration if not to what constitutes a suitable container properly protected from heat; light, and far dlsDcnsInc his druc product. exposure to air or moisture; therefore It Therefore, the Cemmissioner proposes Availability of Economic Impact Study is necessary that the container used by to require RMS the manufacturer in Os May 10.1974, pursuant to (actions 6'b>, 6(0, and 6(0 of the WUliamaSteiger Occupational Safety and Health Act of 1970 (34 Btftt. 1593, 1596,1599; 39 U.S.C. 655, 657), Secretary of Labor's Order Ko. 13-71 (36 FR 0754), and 29 CFR Port 1911. a proposed standard con cerning occupational exposure to vinyl chloride was published in the Feperal Recimzr (39 FR 16806). On June 25-28 and July 8-11, 1974. an Informal rulemaking hearing was held on the proposal pursuant to section 6(b) <3> of the Act. At the clore of the hearing, the presid ing Administrative Law Judge. Gordon J. Myatt, ruled, in accordance with the au thority cionted him under 29 CFR A1J9FJ11.16 g i. that the record would remain m?fpegneunenrtaill August 23,1974 comments and for an the receipt additional nod after that date solely for the sub mission t written comment, on the eco nomic Impact study being conducted for OSHA by an independent consultant. The study, which examines the economic and technological feasibility of compliance with the proposed standard in the monomer, polymer and copolymer pro ducing industries, is now available for examination and copying In Room 230, 1726 M Street, NW., Occupational Safety and Health Administration, Washington, D,C. 20210. All comments regarding the economic impact study should be mailed to tire Docket Oificer, Docket OSH-36, at the above address, and must be post marked no Inter than September 6,1974. the pharmacist in dispensing the drug product to the patient be adequate to maintain the product's original inden- tity, strength, quality, and purity. The monographs for many of the drug products recognized In the official compendia Include requirements for the use of specific types of dispensing con tainers, e.g., light-resistant container, tight container, well-closed container. These requirements for the use of speci fied containers apply to products when dispensed by the pharmacist unless otherwise indicated In the monograph. In the absence of official tests and specifi cations, the pharmacist often has little or no information available to assist him In selecting a suitable container. The Food and Drug Administration has met with representatives of the Na tional Formulary (NJ.) and the United States Pharmacopeia (U.S.P.) to de velop official standards and test proce dures for determining that dispensing containers for prescription drugs meet the requirements for specified types of containers as defined In the official com pendia. The NF. on Januaiy 2, 1974, proposed the first such official standard for tightness of drug containers. The proposal includes a test procedure as well as suggested limits for "tight containers" and "well-closed containers" as defined by the compendia. The proposed require ments are applicable to multiple-unit containers, l.e., a vial or other drug con tainer permitting withdrawal of succes sive doses or portions of the contents. It clude. as past eT the prescription drug produet label, tnfipmation. directed to the pharmacist, ah to the type of con tainer to be imd in dispensing the drug product to the patient. This Information may be In terms of specific materials, containers, or in terms Included in the official compendia to define suitable con tainers. e.g., "Preserve in a tight con tainer". In the caw of containers too small or otherwise unable to accommo date a label with sufficient space to bear this Information, but which arc packaged within an outer container from which they are removed for dispensing or use. this information may be contained in other labeling on or within the package from which it Is to be dispensed. The Commissioner proposes that the requirements of this proposal be imple mented so as to be concurrent with si multaneous implementation of container standards by the NF. and the UJB.P. Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (secs. 502, 503, 505, 507, 701. 52 St&t. 1050-53. 1055-56, as amended. 59 8tat. 463. as emended; 21 U.S.C. 352. 353. 355. 357, 371) and the Public Zlealth Service Act (sec. 351,58 St&t. 702; 42 C.8.C. 262). and under authority delegated to him (21 CFR 2.120), the Commissioner of Food and Drugs proposes to amend Parts land 314 as follows: FART 1--REGULATIONS FOR THE EN FORCEMENT OF THE FEDERAL FOOD, DRUG. AND COSMETIC ACT AND THE Signed at Washington, D.C. this 22nd is anticipated that implementation of the FAIR PACKAGING AND LABELING ACT day of August, 1974. John Sienmr, Assistant Secretary o) Labor, |FK Doc.74-19767 Filed 6-20-74,8:46 ami DEPARTMENT OF HEALTH, EDUCATION, AND WELFAR Food and Drug Administration [21 CFR Part# 1 and 314] standards will be made simultaneously by the NF. and the UjSJP. e Commissioner of Food and Drugs determined that the pharmacist must have information readily available to him as to the type of dispensing con tainer which must be used to maintain a drug product's original identity, strength, quality, and purity. Chemically identical drugs, because of formulation differences, may have different require 1. In 11.106 by revising paragraph (b) (2) (vi). adding a new paragraph (b> (2) (vii> and by revising the undesignated material at the end of paragraph (b) <2> to read as follows: 1.106 Drag* oiid devices; du-Miirm- for nrf. 9 6 69 6 (b) (2) * REQUIREMENTS FDR DISPENSING CONTAINERS FOR PRESCRIPTION DRUGS Notice of Proposed Rulemaking ments for packaging and storage that may not be apparent without extensive testing. It is not reasonable to expect the pharmacist to test each and every drug (vi) An Identifying lot or control num ber from which It is possible to determine the complete manufacturing history of the package of the drug; and Recent trends towards the use of dis product to determine the type of con <vll> A statement directed to the phar pensing containers made of materials tainer that must be used to maintain the macist specifying the type of container j'her than glass and the increased use Identity, strength, quality, and purity of to be used in dispensing the drug prod- act qua! ftfcdkAmir quir tair, divn ami act os Wfc i det be are t diu i cor. I ma an< der of i (st en: sel Ft co; to *P wl to. dl qv (v co tl. pc pr be r p u 1: v X i1 I1 !f KDEEAl REGISTER, VOl 39, NO. 166--MONDAY, AUGUST >6, 1974 OLI 1140