_

 

SUBCHAPTER 9B ‑ RULES AND STANDARDS ADOPTED BY REFERENCE

 

 

02 NCAC 09B .0101          INSPECTOR'S MANUAL

02 NCAC 09B .0102          AOAC METHODS

02 NCAC 09B .0103          NATIONAL FORMULARY

02 NCAC 09B .0104          U.S. PHARMACOPEIA

02 NCAC 09B .0105          ASTM STANDARDS

02 NCAC 09B .0106          REFERENCE MANUALS

 

History Note:        Authority G.S. 150B‑14;

Eff. February 1, 1976;

Repealed Eff. December 14, 1981.

02 NCAC 09B .0107          GENERAL PROVISIONS

02 NCAC 09B .0108          FOOD AND FOOD PRODUCTS

02 NCAC 09B .0109          DRUGS

02 NCAC 09B .0110          DRUGS FOR HUMAN USE

02 NCAC 09B .0111          ANIMAL DRUGS: FEEDS: AND RELATED PRODUCTS

02 NCAC 09B .0112          COSMETICS

02 NCAC 09B .0113          TITLE 40: CODE OF FEDERAL REGULATIONS

02 NCAC 09B .0114          TITLE 9: PART 319: CODE OF FEDERAL REGULATIONS

02 NCAC 09B .0115          TITLE 9: PART 381: CODE OF FEDERAL REGULATIONS

 

History Note:        Authority G.S. 150B‑14;

Eff. February 1, 1976;

Amended Eff. December 20, 1980;

Repealed Eff. December 1, 1981.

 

02 NCAC 09B .0116          ADOPTIONS BY REFERENCE

(a)  The Board incorporates by reference, including subsequent amendments and editions, "Official Methods of Analysis of AOAC," published by the Association of Official Analytical Chemists.  Copies of this document may be obtained from the Association of Official Analytical Chemists International, Department 0742, 1970 Chain Bridge Road, McLean, VA 22109-0742, at a cost of six hundred thirty dollars ($630.00).

(b)  The Board incorporates by reference, including subsequent amendments and editions, "U.S. Pharmacopeia National Formulary USP XXXIII-NFXXVIII" and supplements, published by the U.S. Pharmacopeial Convention, Inc.  Copies of this document may be obtained from The United States Pharmacopeial Convention, Inc., Attention: Customer Service, 12601 Twinbrook Parkway, Rockville, MD 20852, at a cost of eight-hundred fifty dollars ($850.00).

(c)  The Board incorporates by reference, including subsequent amendments and editions, "ASTM Standards on Engine Coolants," published by ASTM International.  Copies of this document may be obtained from ASTM International, 100 Bar Harbor Drive, West Conshohocken, PA 19428-2959, at a cost of two hundred eleven dollars ($211.00).

(d)  The Board incorporates by reference, including subsequent amendments and editions, "EPA Manual of Chemical Methods for Pesticides and Devices" and supplements, published by AOAC.  Copies of this document may be obtained online from the Environmental Protection Agency National Service Center for Environmental Publications at http://nepis.epa.gov/EXE/ZyPURL.cgi?Dockey=2000YS3Y.txt.

(e)  The Board incorporates by reference, including subsequent amendments and editions, "Pesticide Analytical Manual," Volumes I and II, published by the United States Department of Health and Human Services, Food and Drug Administration.  Copies of this document may be obtained online at http://www.fda.gov/Food/Science Research/LaboratoryMethods/PesticideAnalysisManualPAM/default.htm.

(f)  The Board incorporates by reference, including subsequent amendments and editions, "FDA Compliance Policy Guides," published by the United States Department of Health and Human Services, Food and Drug Administration. Copies of this document may be obtained online at http://www.fda.gov/iceci/compliancemanuals/compliancepolicy guidancemanual/default.htm or from the State Information Branch (HFC-151), Division of Federal-State Relations, US Food and Drug Administration, 5600 Fishers Lane, Room 12-07, Rockville, MD 20857.

(g)  The Board incorporates by reference, including subsequent amendments and editions, "Bergey's Manual of Determinative Bacteriology," Lippincott, Williams & Wilkins Company, Baltimore.  Copies of this document may be obtained from the Lippincott, Williams & Wilkins Company, P.O. Box 1620, Hagerstown, MD 21741 at a cost of one hundred thirty-seven dollars and ninety-nine cents ($137.99).

(h)  The Board incorporates by reference, including subsequent amendments and editions, "Microbiology Laboratory Guidebook," published by the United States Department of Agriculture, Food Safety and Inspection Service, Washington, DC. Copies of this document may be obtained online from http://www.fsis.usda.gov science/ microbiological_Lab_Guidebook/ at no charge.

(i)  The Board incorporates by reference, including subsequent amendments and editions, "FDA Bacteriological Analytical Manual," published by the United States Department of Health and Human Services, Food and Drug Administration.  Copies of this document may be obtained online at http://www.fda.gov/Food/FoodScience Research/LaboratoryMethods/ucm114664.htm at no charge.

(j)  The Board incorporates by reference, including subsequent amendments and editions, "Standard Methods for the Examination of Dairy Products," published by the American Public Health Association.  Copies of this document may be obtained from the American Public Health Association Publication Sales, P.O. Box 933019, Atlanta, GA at a cost of eighty-five dollars ($85.00).

(k)  The Board incorporates by reference, including subsequent amendments and editions, "Compendium of Methods for the Microbiological Examination of Foods," published by the American Public Health Association.  Copies of this document may be obtained from the American Public Health Association Publication Sales, P.O. Box 933019, Atlanta, GA at a cost of one hundred fifty dollars ($150.00).

(l)  The Board incorporates by reference, including subsequent amendments and editions, "Bergey's Manual of Systematic Bacteriology," Springer Publishing, New York, NY. Copies of this document may be obtained from Springer Publishing, 233 Spring Street, New York, NY, 10013 at a cost of one hundred fifty-nine dollars ($159.00).

(m)  The Board incorporates by reference, including subsequent amendments and editions, "Manual of Clinical Microbiology," published by the American Society for Microbiology.  Copies of this document may be obtained from the American Society for Microbiology Press, PO Box 605, Herndon, VA 22070, at a cost of two hundred sixty-nine dollars and ninety-five cents ($269.95).

(n)  The Board incorporates by reference, including subsequent amendments and editions, "Standard Methods for the Examination of Water and Waste Water," published by American Public Health Association, American Water Works Association, and Water Pollution Control Federation.  Copies of this document may be obtained from the American Public Health Association Publication Sales, P.O. Box 933019, Atlanta, GA at a cost of two hundred ninety-five dollars ($295.00).

(o)  The Board incorporates by reference, including subsequent amendments and editions, the following parts or sections of the Code of Federal Regulations, Title 21, Chapter I, as promulgated by the Commissioner of the Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act:

Part or

Section   Description of Part or Section

(1)           1.1          General

(2)           1.3          Labeling ‑ Definitions

(3)           1.20        Presence of Mandatory Label Information

(4)           1.21        Failure to Reveal Material Facts

(5)           1.24        Exemptions from Required Label Statements

(6)           1.326      Who is Subject to this Subpart?

(7)           1.327      Who is Excluded from All or Part of the Regulations in this Subpart?

(8)           1.328      What Definitions Apply to this Subpart?

(9)           1.329      Do Other Statutory Provisions and Regulations Apply?

(10)         1.330      Can Existing Records Satisfy the Requirements of this Subpart?

(11)         1.337      What Information Must Non-transporters Establish and Maintain to Identify the

Nontransporter and Transporter Immediate Previous Sources of Food?

(12)         1.345      What Information Must Non-transporters Establish and Maintain to Identify the

Nontransporter and Transporter Immediate Subsequent Recipients of Food?

(13)         1.352      What Information Must Transporters Establish and Maintain?

(14)         1.360      What are the Record Retention Requirements?

(15)         1.361      What are the Record Availability Requirements?

(16)         1.362      What Records are Excluded from this Subpart?

(17)         1.363      What are the Consequences of Failing to Establish, or Maintain Records or Make Them

Available to FDA as Required by this Subpart?

(18)         1.368      What are the Compliance Dates for this Subpart?

(19)         2.25        Grain Seed Treated with Poisonous Substances; Color Identification to Prevent Adulteration of Human and Animal Food

(20)         2.35        Use of Secondhand Containers for the Shipment or Storage of Food and Animal Feed

(21)         7.1          Scope

(22)         7.3          Definitions

(23)         7.12        Guaranty

(24)         7.13        Suggested Forms of Guaranty

(25)         7.40        Recall Policy

(26)         7.41        Health Hazard Evaluation and Recall Classification

(27)         7.42        Recall Strategy

(28)         7.45        Food and Drug Administration - Requested Recall

(29)         7.46        Firm-initiated Recall

(30)         7.49        Recall Communications

(31)         7.50        Public Notification of Recall

(32)         7.53        Recall Status Reports

(33)         7.55        Termination of a Recall

(34)         7.59        General Industry Guidance

(35)         70           Color Additives

(36)         73           Listing of Color Additives Exempt from Certification

(37)         74           Listing of Color Additives Subject to Certification

(38)         81           General Specifications and General Restrictions for Provisioned Color Additives for Use in Foods, Drugs and Cosmetics

(39)         82           Listing of Certified Provisionally Listed Colors and Specifications

(40)         100         General

(41)         101         Food Labeling

(42)         102         Common or Usual Name for Nonstandardized Foods

(43)         104         Nutritional Quality Guidelines for Foods

(44)         105         Foods for Special Dietary Use

(45)         106         Infant Formula Quality Control Procedures

(46)         107         Infant Formula

(47)         108         Emergency Permit Control

(48)         109         Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material

(49)         110         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food

(50)         111         Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

(51)         113         Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers

(52)         114         Acidified Foods

(53)         115         Shell Eggs

(54)         118         Production, Storage, and Transportation of Shell Eggs

(55)         120         Hazard Analysis and Critical Control Point (HACCP) Systems

(56)         123         Fish and Fishery Products

(57)         129         Processing and Bottling of Bottled Drinking Water (Except as amended by 02 NCAC 09C .0700 ‑ Bottled Water)

(58)         130         Food Standards:  General

(59)         131         Milk and Cream

(60)         133         Cheeses and Related Cheese Products

(61)         135         Frozen Desserts

(62)         136         Bakery Products

(63)         137         Cereal Flours and Related Products

(64)         139         Macaroni and Noodle Products

(65)         145         Canned Fruits

(66)         146         Canned Fruit Juices

(67)         150         Fruit Butters, Jellies, Preserves, and Related Products

(68)         152         Fruit Pies

(69)         155         Canned Vegetables

(70)         156         Vegetable Juices

(71)         158         Frozen Vegetables

(72)         160         Eggs and Egg Products

(73)         161         Fish and Shellfish (Except Section 161.30 and 161.130 through 161.145)

(74)         163         Cacao Products

(75)         164         Tree Nut and Peanut Products

(76)         165         Beverages

(77)         166         Margarine

(78)         168         Sweeteners and Table Syrups

(79)         169         Food Dressings and Flavorings

(80)         170         Food Additives

(81)         172         Food Additives Permitted for Direct Addition to Food for Human Consumption

(82)         173         Secondary Direct Food Additives Permitted in Food for Human Consumption

(83)         174         Indirect Food Additives:  General

(84)         175         Indirect Food Additives:  Adhesives and Components of Coatings

(85)         176         Indirect Food Additives:  Paper and Paperboard Components

(86)         177         Indirect Food Additives:  Indirect Food Additives: Polymers

(87)         178         Indirect Food Additives:  Adjuvants, Production Aids, and Sanitizers

(88)         179         Irradiation in the Production, Processing and Handling of Food

(89)         180         Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study

(90)         181         Prior-Sanctioned Food Ingredients

(91)         182         Substances Generally Recognized as Safe

(92)         184         Direct Food Substances Affirmed as Generally Recognized as Safe

(93)         186         Indirect Food Substances Affirmed as Generally Recognized as Safe

(94)         189         Substances Prohibited from Use in Human Food

(95)         190         Dietary Supplements

(96)         200         General

(97)         201         Labeling

(98)         202         Prescription Drug Advertising

(99)         210         Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General

(100)      211         Current Good Manufacturing Practice for Finished Pharmaceuticals

(101)      225         Current Good Manufacturing Practice for Medicated Feeds

(102)      226         Current Good Manufacturing Practice for Type A Medicated Articles

(103)      250         Special Requirements for Specific Human Drugs

(104)      290         Controlled Drugs

(105)      299         Drugs; Official Names and Established Names

(106)      300         General

(107)      310         New Drugs

(108)      312         Investigational New Drug Application

(109)      314         Applications for FDA Approval to Market New Drug

(110)      320         Bioavailability and Bioequivalence Requirements

(111)      330         Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded

(112)      331         Antacid Products for Over-the-Counter (OTC) Human Use

(113)      332         Antiflatulent Products for Over-the-Counter Human Use

(114)      361         Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research

(115)      369         Interpretive Statements Re: Warnings on Drugs and Devices for Over-the-Counter Sale

(116)      809         In Vitro Diagnostic Products for Human Use

(117)      812         Investigational Device Exemptions

(118)      820         Quality System Regulation

(119)      860         Medical Device Classification Procedures

(120)      861         Procedures for Performance Standards Development

(121)      870         Cardiovascular Devices

(122)      882         Neurological Devices

(123)      884         Obstetrical and Gynecological Devices

(124)      895         Banned Devices

(125)      500         General

(126)      501         Animal Food Labeling

(127)      502         Common or Usual Names for Nonstandardized Animal Foods

(128)      509         Unavoidable Contaminants in Animal Food and Food-Packaging Material

(129)      510         New Animal Drugs

(130)      511         New Animal Drugs for Investigational Use

(131)      514         New Animal Drug Applications

(132)      520         Oral Dosage Form New Animal Drugs

(133)      522         Implantation or Injectable Dosage Form New Animal Drugs

(134)      524         Ophthalmic and Topical Dosage Form New Animal Drugs

(135)      526         Intramammary Dosage Form New Animal Drugs

(136)      529         Certain Other Dosage Form New Animal Drugs

(137)      556         Tolerances for Residues of New Animal Drugs in Food

(138)      558         New Animal Drugs for Use in Animal Feeds

(139)      570         Food Additives

(140)      573         Food Additives Permitted in Feed and Drinking Water of Animals

(141)      582         Substances Generally Recognized as Safe

(142)      584         Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of Animals

(143)      589         Substances Prohibited from Use in Animal Food or Feed

(144)      700         General

(145)      701         Cosmetic Labeling

(146)      720         Voluntary Filing of Cosmetic Product Ingredient Composition Statements

(147)      740         Cosmetic Product Warning Statements

Copies of the Code of Federal Regulations may be obtained at no cost by accessing the website of the U.S. Government Printing Office at http://www.gpoaccess.gov/cfr/index.html.

(p)  The Board incorporates by reference, including subsequent amendments and editions, "Tolerances and Exemptions from Tolerances for Pesticide Chemicals in or on Raw Agricultural Commodities," 40 C.F.R. Part 180. Copies of the Code of Federal Regulations may be obtained at no cost by accessing the website of the U.S. Government Printing Office at http://www.gpoaccess.gov/cfr/index.html.

(q)  The Board incorporates by reference, including subsequent amendments and editions, "Definitions and Standards of Identity or Composition for Meats, Meat By-products, and Meat Food Products," 9 C.F.R. Part 319. Copies of the Code of Federal Regulations may be obtained at no cost by accessing the website of the U.S. Government Printing Office at http://www.gpoaccess.gov/cfr/index.html.

(r)  The Board incorporates by reference, including subsequent amendments and editions, "Definitions and Standards of Identity or Composition for Poultry and Poultry Products," 9 C.F.R. Sections 381.155 through 381.170. Copies of the Code of Federal Regulations may be obtained at no cost by accessing the website of the U.S. Government Printing Office at http://www.gpoaccess.gov/cfr/index.html.

(s)  The Board incorporates by reference, including subsequent amendments and editions, Title 9, Part 317.2(1) of the Code of Federal Regulations.  Copies of Title 9 of the Code of Federal Regulations may be obtained from the Superintendent of Documents, Government Printing Office, Washington, DC 20402, at a cost of sixty-four dollars ($64.00).

(t)  The Board incorporates by reference, including subsequent amendments and editions, Title 9, Part 381.125(b) of the Code of Federal Regulations.  Copies of the Code of Federal Regulations may be obtained at no cost by accessing the website of the U.S. Government Printing Office at http://www.gpoaccess.gov/cfr/index.html.

(u)  The Board incorporates by reference, including subsequent amendments and editions, a document entitled, "Fresh Air '2000' - A Look At FDA's Medical Gas Requirements," published by the United States Department of Health and Human Services, Food and Drug Administration.  A copy of this material may be obtained at no cost from the Food and Drug Protection Division of the North Carolina Department of Agriculture and Consumer Services.

(v)  The Board incorporates by reference the definition of "dietary supplement" found at 21 USC 321(ff).

 

History Note:        Authority G.S. 106-139; 106-245.16; 106-245.22; 106-245.32; 106-267;

Eff. December 14, 1981;

Amended Eff. May 1, 2013; January 1, 2011; June 1, 2004; April 1, 2003; June 1, 1995; April 1, 1992; June 1, 1988; October 1, 1987;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.

 

02 NCAC 09B .0117          NATIONAL FORMULARY

 

History Note:        Authority G.S. 150B‑14;

Eff. December 14, 1981;

Repealed Eff. January 1, 1985.

 

02 NCAC 09B .0118          U.S. PHARMACOPEIA NATIONAL FORMULARY

 

History Note:        Authority G.S. 106‑139; 106‑267; 106‑267.2;

Eff. December 14, 1981;

Amended Eff. January 1, 1985;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0119          ASTM STANDARDS

 

History Note:        Authority G.S. 106‑139; 106‑267; 106‑267.2;

Eff. December 14, 1981;

Amended Eff. January 1, 1985;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0120          REFERENCE MANUALS

 

History Note:        Authority G.S. 106‑139; 106‑267; 106‑267.2;

Eff. December 14, 1981;

Amended Eff. January 1, 1985;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0121          GENERAL

 

History Note:        Authority G.S. 106‑139; 150B‑14;

Eff. December 1, 1981;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0122          FOOD FOR HUMAN CONSUMPTION

 

History Note:        Authority G.S. 106‑139; 150B‑14;

Eff. December 1, 1981;

Amended Eff. January 1, 1987; July 1, 1985; March 1, 1985; June 1, 1984;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0123          DRUGS

 

History Note:        Authority G.S. 106‑139; 150B‑14;

Eff. December 1, 1981;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0124          DRUGS FOR HUMAN USE

 

History Note:        Authority G.S. 106‑139; 150B‑14;

Eff. December 1, 1981;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0125          MEDICAL DEVICES

 

History Note:        Authority G. S. 106‑139; 150B‑14;

Eff. December 1, 1981;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0126          ANIMAL DRUGS: FEEDS: AND RELATED PRODUCTS

 

History Note:        Authority G.S. 106‑139; 150B‑14;

Eff. December 1, 1981;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0127          COSMETICS

 

History Note:        Authority G.S. 106‑139; 150B‑14;

Eff. December 1, 1981;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0128          TITLE 40: CODE OF FEDERAL REGULATIONS

 

History Note:        Authority G.S. 106‑139; 150B‑14;

Eff. December 1, 1981;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0129          TITLE 9: PART 319: CODE OF FEDERAL REGULATIONS

 

History Note:        Authority G.S. 106‑139; 150B‑14;

Eff. December 1, 1981;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0130          TITLE 9: PART 381: CODE OF FEDERAL REGULATIONS

 

History Note:        Authority G.S. 106‑139; 150B‑14;

Eff. December 1, 1981;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0131          ETHYLENE DIBROMIDE TOLERANCE

 

History Note:        Authority G.S. 106‑139;

Temporary Rule Eff. February 6, 1984, for a Period of 120 Days to Expire on June 4, 1984;

Eff. June 1, 1984;

Pursuant to G.S. 150B-21.3A, rule Expired April 1, 2015.

 

02 NCAC 09B .0132          EFFECTIVE DATE FOR ADOPTIONS BY REFERENCE

 

History Note:        Authority G.S. 106‑139; 150B‑14;

Eff. January 1, 1987;

Transferred to T02.09B .0016 Eff. April 1, 1987.

 

02 NCAC 09B .0133          DOCUMENT AVAILABILITY

Copies of documents adopted by reference in 02 NCAC 09B .0116 are available for inspection in the Office of the Director of the Food and Drug Protection Division and may be obtained at a cost as determined by the publisher by contacting the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402.

 

History Note:        Authority G.S. 106‑139; 150B‑14;

Eff. January 1, 1987;

Amended Eff. June 1, 1988;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.