CFR > Title 21 - Food and Drugs > CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE > PART 1311—REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS > SUBPART C—Electronic Prescriptions (§1311.100 to §1311.305) > 1311.150—Additional requirements for internal application audits.

1311.150—Additional requirements for internal application audits.

(a) Description. Heavy cream is cream which contains not less than 36 percent milkfat. It is pasteurized or ultra-pasteurized, and may be homogenized.
(b) Optional ingredients. The following safe and suitable optional ingredients may be used:
(1) Emulsifiers.
(2) Stabilizers.
(3) Nutritive sweeteners.
(4) Characterizing flavoring ingredients (with or without coloring) as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit juice).
(ii) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), sections 16.156 and 16.059, under “Fat, Roese-Gottlieb Method—Official Final Action,” 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.
(d) Nomenclature. (1) The name of the food is “Heavy cream” or alternatively “Heavy whipping cream”. 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. 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) The word “ultra-pasteurized” if the food has been ultra-pasteurized.
(ii) The word “sweetened” if no characterizing flavoring ingredients are used, but nutritive sweetener is added.
(2) The following terms may appear on the label:
(i) The word “pasteurized” if the food has been pasteurized.
(ii) The word “homogenized” if the food has been homogenized.
(e) 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

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993]
(a) The application provider must establish and implement a list of auditable events. Auditable events must, at a minimum, include the following:
(1) Attempted unauthorized access to the electronic prescription application, or successful unauthorized access where the determination of such is feasible.
(2) Attempted unauthorized modification or destruction of any information or records required by this part, or successful unauthorized modification or destruction of any information or records required by this part where the determination of such is feasible.
(3) Interference with application operations of the prescription application.
(4) Any setting of or change to logical access controls related to the issuance of controlled substance prescriptions.
(5) Attempted or successful interference with audit trail functions.
(6) For application service providers, attempted or successful creation, modification, or destruction of controlled substance prescriptions or logical access controls related to controlled substance prescriptions by any agent or employee of the application service provider.
(b) The electronic prescription application must analyze the audit trail at least once every calendar day and generate an incident report that identifies each auditable event.
(c) Any person designated to set logical access controls under §§ 1311.125 or 1311.130 must determine whether any identified auditable event represents a security incident that compromised or could have compromised the integrity of the prescription records. Any such incidents must be reported to the electronic prescription application provider and the Administration within one business day.