Document baDGMybn4dNnRGOnDZpM38y51

30844 5m & prcposscJrules VWs **cton *4 th* FEDERAL REGISTER wntain* notie** to th* public of tM praeotod iMuaneo of rate* pud MfulaHont. Th* pwpoto at IMaa natloaa l to giv* Maraatad pafaam an opportunity a partidpata la no rufamaklng prior ta too adaption at tho Snal Mn. \ DEPARTMENT OF LABOR Occupational Safety and Health Administration of Aims, laminates, papers, and foils pre tho product after it has been dispensed 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 to the person moot able [29 CFR Part 1910] (Docket No. OdB-Ml ' VINYL CHLORIDE Many drug products are subiect to de to supply the necessary information as composition or deterioration if not to what constitutes ^ suitable container properly protected from heat, light, and tor dispensing Ids Afar product. exposure to air or moisture; therefore it Therefore, the CoOphissioncr proposes Availability of Economic Impact Study la necessary that the container used by to require that tho manufacturer in On May 10. 1974, pursuant to sections 6(b>, 6(c), and 8(c) of the Williams-, Steiger Occupational Safety and Health Act Of 1970 (84 Stat. 1593. 1596,1599; 29 U.S.C. 655. 657 i, Secretary of Labor's Order No. 12-71 (36 FR 8754). and 29 CFR Fart 1911. a proposed standard concemlns occupational exposure to vinyl chloride teas published in the Pedxkal Register (39 FR 16896). On June 25-28 and July 8-11. 1974, an Informal rule making hearing was held on the proposal pursuant to section 6(b) (3> of the Act. At the close of the hearing, the presid the pharmacist in dispensing the drug product to the patient be adequate to maintain the product's original indentity, 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 clude, us pert el tho prescription drug product label, information, directed to the pharmacist, ss to the type of con tainer to be used 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 case of containers too email or otherwise unable to accommo date a label with suficient space to bear this information, but which are packaged within an outer container from which they are removed for dispensing or use. ing Administrative Law Judge, Gordon J- cations. the pharmacist often has little this information may be contained in Myatt, ruled, in accordance with the au thority granted him under 29 CFR l^M6(gj, that the record would remain d^^irtil August 23,1974 for the receipt of general comments ai.u an additional period after that date solely for the sub mission of written comment, on the eco nomic impact study being conducted for OSHA by sn 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. N3V., Occupational Safety or no information available to assist him in selecting a suitable container. The Food and Drug Administration IiAa met with representatives of the Na tional Formulary (N.F.) 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 NJ. on January 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" other labeling on or within the package from which it is to be dispensed. The Commissioner proposes that the requirements of this proposal b: imple mented so as to oe concurrent with si multaneous implementation of container atundards by the NJ. and the DRP. Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (secs. 502, 503. 505, 507, 701, 52 Stat. 1C50-53, 1055-56, as amended. 59 Stat. 463, as amended; 21 U.S.C. 352, 353, 355. 357, 371) and the Public Health Service Act (Sec. 351, 58 stat. 702: 42 U.S.C. 262), and under authority delegated to him (21 CFR 2.120). the Commissioner of and Health Administration, Washington, and "well-closed containers" as defined Food and Drugs proposes to amend Parts D.C. 20210. All comments regarding the economic impact study should be mailed by the compendia. The proposed require ments are applicable to multiple-unit 1 and 314 as follows: to the T.V*?Vet. Officer, Docket OSH-36, at the above address, and must be post marked no later than September 6,1974. containers, l.a . a vial or ether drug con tainer permitting withdrawal of succes sive doses or portions of the contents. It PART 2--REGULATION'S FOR THE EN FORCEMENT OF THE FEDERAL FOOD. DRUG. AND COSMETIC ACT AND THE Signed at Washington, D.C. this 22nd day of August, 1974. John Stehdex, Assistant Secretary of Labor. |FR Doe.7*-l?7 Filed 8-23-74,1:48 am] DEPARTMENT CF HEALTH, EDUCATION, AND WELFARE is anticipated that implementation of the standards will be made simultaneously by the NT. and the U.S.P. The Commissioner of Food and Drugs has determined that the pharmacist must have information readily available to him ss to the type of dispensing con tainer which must be used to maintain a drug product's original identity, FAIR PACKAGING AND LABELING ACT 1. In 11.106 by revising paragraph (b) (2) (vl). adding a new paragraph (b) (2) (viii and by revising the undesignated material at the end of paragraph (b) (2) to read as follows; S 1,106 Drug* and device** direction* for u*e. Food and Drug Administration [ 21 CFR Parts 1 and 314 ] strength, c.uallty, and purity. Chemically identical drugs, because of formulation differences, may have different require ((b2)) * * * REQUIREMENTS TOf: 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 ^Bicent trends towards the use of dls- product to determine the type of con (vli) A statement directed to the phar ^Hsing containers made of materials tainer that must be used to maintain the macist specifying the tyj>e of container otner than glass and the increased use identity, strength, quality, act! purity of to be used in dispensing the drug prod- OLI 1167 FEDEEAl AEGISTEA. VOl. 3*, N . 146--MONOAT, AUGUST 36, 1974