Committee on Drugs and Related Topics

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METHODS COMMITTEE REPORTS: JOURNAL OF AOAC INTERNATIONAL VOL. 84, NO. 1, 2001 also decided to change our definition of quorum from 2 3 to a Committee on Drugs and Related Topics simple majority of members. John O’Rangers presented the committee with a proposal for laboratory sharing of incurred CATHARINA Y.W. ANG, CHAIR residue tissue, which is necessary for the validation of veteriU.S. Food and Drug Administration, National Center for nary drug residue methods. The committee agreed to forward Toxicological Research, 3900 NCTR Rd, Jefferson, AR 72079 this proposal to the Official Methods Board. The letter requesting AOAC assistance is attached to this report. LEENDERT A. VAN GINKEL, SECRETARY During the past year, the committee filled the following National Institute of Public Health and the Environment, General Referee positions: Cosmetics: David M. Prantis, PO Box 1, 3720 AB Bilthoven, The Netherlands Avon Products, Inc., Suffern, NY; Drug Residues in Foods, Diagnostics and Test Kits: Joe Boison, CFIS, Saskatoon, SK, GEORGE F. PETERSON, SAFETY ADVISOR Canada; and Forensics: Robert Bianchi, Fairfax, VA. Bureau of Alcohol, Tobacco, and Firearms, 35575 Conovan Ln, Fremont, CA 94536

Cosmetics, David Prantis

JAMES CHEN, STATISTICAL ADVISOR U.S. Food and Drug Administration, National Center for Toxicological Research, 4 Serian Cir, Little Rock, AR 72223

There are no current studies or protocols in this area. This new General Referee is attempting to revitalize activity in this area, which includes drugs such as sunscreens, antifungal agents, retinoic acid, and other active ingredients in cosmetic formulations. AOAC strongly encourages potential Topic Advisors and Study Directors to contact the General Referee, any Committee member, or AOAC for additional information.

MARY C. CARSON (ACTING SECRETARY) U.S. Food and Drug Administration, Center for Veterinary Medicine, 8401 Muirkirk Rd, Laurel, MD 20708 VALERIE B. REEVE U.S. Food and Drug Administration, Center for Veterinary Medicine, 7500 Standish Pl, Rockville, MD 20850 THOMAS P. LAYLOFF U.S. Pharmacopeia, 12601 Twinbrook Pkwy, Rockville, MD 20852

Drug Residues in Animal Tissues, James MacNeil (1) At the Methods Committee on Drugs and Related Topics Meeting on April 14, 2000, it was recommended that the following 2 Associate Referee topics that were previously under Jim MacNeil, General Referee for Drug Residues in Animal Tissues, be transferred to Drug Residues in Foods, Diagnostics and Test Kits:

LINDA NG U.S. Food and Drug Administration, CDER, HFD-550, 5600 Fishers Ln, Rockville, MD 20857

• Beta-Lactam Residues in Milk, Delvotest (Vacant Associate Referee).

JACK F. KAY Ministry of Agriculture, Fisheries and Food, VMD, Woodham Ln, Addlestone, Surrey, UK

• Beta-Lactams in Tissues by Quantitative Competitive Microbial Receptor Assay (Vacant Associate Referee)

GALEN W. RADEBOUGH Schering-Plough Research Institute, 2000 Galloping Hill Rd, Kenilworth, NJ 07033 DAVID J. MAZZO Schering-Plough Research Institute, 2000 Galloping Hill Rd, Kenilworth, NJ 07033 MIN LI CDFA, Center for Analytical Chemistry, 3292 Meadowview Rd, Sacramento, CA 95832 Committee Actions The committee voted at the September 2000 meeting to allow members to be represented by a proxy. The committee

(2) 994.09 Chlortetracycline, Oxytetracycline, and Tetracycline in Edible Animal Tissues, LC Method: Associate Referee James D. MacNeil. Method approved for Final Action. See proposed modification below. (3) Tetracyclines in Milk: Associate Referee Mary C. Carson. Method approved Final Action. Discontinue study. (4) Improved Analysis of Tetracycline Residues in Swine Tissues Using Polymer-Based Extraction Cartridges: Associate Referee J. Zmudzki reported results of a 5-laboratory study in J. AOAC Int. Continue study. (5) Determination of Clopidol in Chicken Tissues: Associate Referee Guo-Fang Pang appointed and method submitted for publication. Collaborative study protocol under review. Continue study. (6) Determination of ivermectin residues in animal tissues: Appoint a Study Director.

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Drugs, Elaine Bunch (1) Aminobenzoic Acid and Salicylic Acid Salts in Pharmaceuticals: Associate Referee Richard D. Thompson, formerly U.S. Food and Drug Association (FDA), 4740 York Ave S, Minneapolis, MN 55410, USA, Tel: +1-612-922-4775, is reviewing the collaborative study data for this method. He plans to complete this review and publish the results this year. Continue Study. (2) Atenolone in Combination with Chlorthalidone: Associate Referee Everett H. Jefferson, FDA, Division of Product Quality Research, Rm 2417, 5516 Nicholson Ln, Kensington, MD 20895, Tel: +1-301-827-5246, E-mail: [email protected], reports that no work was accomplished this year. He plans to publish his method for this topic in J. AOAC Int. Continue Study. (3) Belladonna Alkaloids: Associate Referee Luis Levy, INEXACA, PO Box 17-08-8354, Quito, Ecuador, Tel: +593-2-23440, Fax: +593-2-564906, did not submit a report. Continue Study. (4) 985.49. Colchicine in Tablets: Associate Referee Richard D. Thompson has resigned as the Associate Referee for this topic. Because collaborative study for colchicine as a single ingredient has previously been published (1) and been adopted as Final Action in 1987, he recommends that this topic be discontinued. Colchicine is no longer available as a single component. Discontinue Study. (5) 988.27 Dexamethasone in Tablets: Associate Referee Elaine A. Bunch, FDA, 22201 23rd Dr SE, Bothell, WA 98021, Tel: +1-425-483-4887, Fax: +1-425-483-4996, E-mail: [email protected], reported that the validation of the HPLC method for dexamethasone in tablets continues (3, 4, 5, 6). The method for dexamethasone in bulk drug and elixirs was adopted as Final Action in 1992. Continue validation of HPLC method for tablets. (6) Guiafenesin: Associate Referee Myron Rhodes, formerly FDA, Division of Drug Analysis, 1114 Market St, St. Louis, MO 63101, is no longer working on this topic. This topic is now vacant. Seeking new Associate Referee. (7) Heroin Hydrochloride in Powders: Associate Referee Charles C. Clark, formerly Drug Enforcement Agency, 5205 NW 84th Ave, Miami, FL 33166, has retired and is no longer working on this topic. This topic is now vacant. Seeking new Associate Referee. (8) Histamine Diphosphate: Associate Referee William Juhl, formerly FDA, Division of Drug Analysis, 1114 Market St, St. Louis, MO 63101, is no longer working on this topic. This topic is now vacant. Seeking new Associate Referee. (9) Reserpine and Rescinnamine in Rauwolfia serpentina Powders and Tablets, HPLC Method: Associate Referee Ugo Cieri, FDA, 2nd & Chestnut Sts, Rm 900, Philadelphia, PA 19106, Tel: +1-215-597-7383, Fax: +1-215-597-5728, E-mail: [email protected], is planning either a collaborative study or peer-verified method trial for “Determination of reserpine by LC with fluorescence detection (applicable in presence of hydrochlorothiazide, hydroflumethiazide, methyclothiazide).” The type of study issued by Cieri will de-

pend on the number of participating laboratories that commit to this study. Seeking collaborative laboratories. Continue study. Previously, a collaborated method for reserpine and rescinnamine in Rauwolfia serpentina was adopted as First Action in 1997, Method 997.10 (7, 8). (10) Terfenadine: Associate Referee Jettie Travis-Bryant, formerly FDA, Division of Drug Analysis, 1114 Market St, St. Louis, MO 63101, is no longer working on this topic. FDA withdrew approval for Seldane (terfenadine) and Seldane D (terfenadine and pseudoephedrine) and generic versions of this prescription antihistamine in 1997. Seeking Associate Referee for terfenadine. (11) 968.45, 968.43, 960.54, 958.14, 943.08 and 943.07: Recommend surplus status. (12) 958.10. Antihistamines in Drugs in Presence of Aspirin, Phenacetin, and Caffeine: FDA withdrew Phenacetin from the market in 1986. Recommend surplus status. (13) 972.48 Dichlorophene in Drugs: Dichlorophene no longer has products listed in the 2000 issue of Drug Facts and Comparisons. Recommend surplus status. (14) 959.15 Methapyrilene in Expectorants: The National Cancer Institute concluded that Methapyriline was a potent carcinogen. In 1979, FDA withdrew approval to market Methapyriline and it is considered to be a new drug without an approved New Drug Application. Recommend surplus status. (15) Seek Associate Referees for the topics: Anabolic Steroids Bulk Materials by LC or GC, Corticosteroids in Tablets, Cromolyn Sodium in Bulk and Dosage Forms; Dicyclomine; Guiafenesin, Ergot Alkaloids; Heroin in Powders, Histamine Diphosphate, and Progestational Steroids. Drug Residues in Foods, Diagnostics and Test Kits, Joe Boison This topic was recently separated from the more general Drug Residues in Animal Tissues topic. Both Associate Referee positions are currently vacant. The General Referee will search for new Topic Advisors and Study Directors. (1) Beta-Lactam Residues in Milk, Delvotest: Vacant. Seeking Associate Referee. Interested scientists or collaborators are asked to contact this General Referee or AOAC INTERNATIONAL for information. (2) Beta-Lactams in Tissues by Quantitative Competitive Microbial Receptor Assay: Vacant. Seeking Associate Referee. Interested scientists or collaborators are asked to contact this General Referee or AOAC INTERNATIONAL for information. (3) General Referee will work closely with the AOAC Research Institute (RI) and its expert reviewers to review validation protocol requirements and data for Performance Tested Methods. (4) General Referee will work closely with the RI and the J. AOAC Int. Editorial Board to expedite the publication of Performance Tested Methods. Forensic Sciences, Robert Bianchi The General Referee is newly appointed and did not submit a report.

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References

(5) Bunch, E.A. (1982) J. Pharm. Sci. 71, 1424–1426

(1) Thompson, R.D. (1985) J. AOAC Int. 68, 1051–1055 (2) Thompson, R.D., Official Methods of Analysis of AOAC INTERNATIONAL, 16th Ed., sec. 20.6.01, Method 985.49 (3) Bunch, E.A. (1987) J. AOAC Int. 70, 967–973 (4) Bunch, E.A. (1987) J. AOAC Int. 70, 560–565, 967–973

(6) Bunch, E.A., Official Methods of Analysis of AOAC INTERNATIONAL, 15th Ed., Method 988.27 (7) Cieri, U. (1998) J. AOAC Int. 81, 373–380 (8) Cieri, U., Official Methods of Analysis of AOAC INTERNATIONAL, 16th Ed., Method 997.10, sec. 20.9.06A