1311.110—Requirements for obtaining an authentication credential—Individual practitioners eligible to use an electronic prescription application of an institutional practitioner.
(a) Description.
Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. Milk that is in final package form for beverage use shall have been pasteurized or ultrapasteurized, and shall contain not less than 8 1/4 percent milk solids not fat and not less than 3 1/4 percent milkfat. Milk may have been adjusted by separating part of the milkfat therefrom, or by adding thereto cream, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. Milk may be homogenized.
(b)
Vitamin addition (Optional). (1) If added, vitamin A shall be present in such quantity that each quart of the food contains not less than 2000 International Units thereof within limits of good manufacturing practice.
(2)
If added, vitamin D shall be present in such quantity that each quart of the food contains 400 International Units thereof within limits of good manufacturing practice.
(2)
Characterizing flavoring ingredients (with or without coloring, nutritive sweetener, emulsifiers, and stabilizers) as follows:
(d) Methods of analysis.
Referenced methods are from “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(2)
Milk solids not fat content—Calculated by subtracting the milk fat content from the total solids content as determined by the method “Total Solids, Method I—Official Final Action,” section 16.032.
(e) Nomenclature.
The name of the food is “milk”. The name of the food shall be accompanied on the label by a declaration indicating the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.
(1)
The following terms shall accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half the height of the letters used in such name:
(i)
If vitamins are added, the phrase “vitamin A” or “vitamin A added”, or “vitamin D” or “vitamin D added”, or “vitamin A and D” or “vitamins A and D added”, as is appropriate. The word “vitamin” may be abbreviated “vit.”.
(f) Label declaration.
Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.
Code of Federal Regulations
(a)
For any registrant or person exempted from the requirement of registration under § 1301.22(c) of this chapter who is eligible to use the institutional practitioner's electronic prescription application to sign prescriptions for controlled substances, the entity within a DEA-registered institutional practitioner that grants that individual practitioner privileges at the institutional practitioner (e.g., a hospital credentialing office) may conduct identity proofing and authorize the issuance of the authentication credential. That entity must do the following:
(1)
Ensure that photographic identification issued by the Federal Government or a State government matches the person presenting the identification.
(2)
Ensure that the individual practitioner's State authorization to practice and, where applicable, State authorization to prescribe controlled substances, is current and in good standing.
(3)
Either ensure that the individual practitioner's DEA registration is current and in good standing or ensure that the institutional practitioner has granted the individual practitioner exempt from the requirement of registration under § 1301.22 of this chapter privileges to prescribe controlled substances using the institutional practitioner's DEA registration number.
(4)
If the individual practitioner is an employee of a health care facility that is operated by the Department of Veterans Affairs, confirm that the individual practitioner has been duly appointed to practice at that facility by the Secretary of the Department of Veterans Affairs pursuant to 38 U.S.C. 7401-740 8.
(5)
If the individual practitioner is working at a health care facility operated by the Department of Veterans Affairs on a contractual basis pursuant to 38 U.S.C. 8153 and, in the performance of his duties, prescribes controlled substances, confirm that the individual practitioner meets the criteria for eligibility for appointment under 38 U.S.C. 7401-740 8 and is prescribing controlled substances under the registration of such facility.
(b)
An institutional practitioner that elects to conduct identity proofing must provide authorization to issue the authentication credentials to a separate entity within the institutional practitioner or to an outside credential Service provider or certification authority that meets the requirements of § 1311.105(a).
(c)
When an institutional practitioner is conducting identity proofing and submitting information to a credential service provider or certification authority to authorize the issuance of authentication credentials, the institutional practitioner must meet any requirements that the credential service provider or certification authority imposes on entities that serve as trusted agents.
(d)
An institutional practitioner that elects to conduct identity proofing and authorize the issuance of the authentication credential as provided in paragraphs (a) through (c) of this section must do so in a manner consistent with the institutional practitioner's general obligation to maintain effective controls against diversion. Failure to meet this obligation may result in remedial action consistent with § 1301.36 of this chapter.
(e)
An institutional practitioner that elects to conduct identity proofing must retain a record of the identity-proofing. An institutional practitioner that elects to issue the two-factor authentication credential must retain a record of the issuance of the credential.