Source: https://casetext.com/regulation/code-of-federal-regulations/title-21-food-and-drugs/chapter-ii-drug-enforcement-administration-department-of-justice/part-1304-records-and-reports-of-registrants/inventory-requirements/130411-inventory-requirements?ref=AsVVwS!DLkGYz
Timestamp: 2019-12-14 09:13:49
Document Index: 388299577

Matched Legal Cases: ['§ 1304', '§ 1304', '§ 1304', '§ 1304', '§ 1308', '§ 1301', 'art 1317', '§ 1304']

§ 1304.11 Inventory requirements, 21 C.F.R. § 1304.11 | Casetext
21 C.F.R. § 1304.11
§ 1304.11 Inventory requirements
ReadReadAnnotationsAnnotations0Attorney AnalysesAnalyses1Citing BriefsBriefs0Citing CasesCiting Cases6
(d) Inventory date for newly controlled substances. On the effective date of a rule by the Administrator pursuant to §§ 1308.45, 1308.46, or 1308.47 of this chapter adding a substance to any schedule of controlled substances, which substance was, immediately prior to that date, not listed on any such schedule, every registrant required to keep records who possesses that substance shall take an inventory of all stocks of the substance on hand. Thereafter, such substance shall be included in each inventory made by the registrant pursuant to paragraph (c) of this section.
(e) Inventories of manufacturers, distributors, registrants that reverse distribute, importers, exporters, chemical analysts, dispensers, researchers, and collectors. Each person registered or authorized (by §§ 1301.13, 1307.11, 1307.13, or part 1317 of this chapter) to manufacture, distribute, reverse distribute, dispense, import, export, conduct research or chemical analysis with controlled substances, or collect controlled substances from ultimate users, and required to keep records pursuant to § 1304.03 shall include in the inventory the information listed below.
(C) The physical form which the substance is to take upon completion of the manufacturing process (e.g, granulations, tablets, capsules, or solutions), identified by the batch number or other appropriate identifying number, and if possible the finished form of the substance (e.g, 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number or volume thereof.
(B) Each finished form of the substance (e.g, 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);
(C) The number of units or volume of each finished form in each commercial container (e.g, 100-tablet bottle or 3-milliliter vial); and
(iv) For each controlled substance not included in paragraphs (e)(1) (i), (ii) or (iii) of this section (e.g, damaged, defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compoundings) the inventories shall include:
(B) For each controlled substance in finished form: Each finished form of the substance (e.g, 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter); the number of units or volume of each finished form in each commercial container (e.g, 100-tablet bottle or 3-milliliter vial); and the number of commercial containers of each such finished form (e.g, four 100-tablet bottles or six 3-milliliter vials); and
(iii) For controlled substances acquired from collectors and law enforcement: The number and size (e.g, five 10-gallon liners, etc.) of sealed inner liners on hand, or
(4) Inventories of importers and exporters. Each person registered or authorized to import or export controlled substances shall include in the inventory the same information required of manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this section. Each such person who is also registered as a manufacturer or as a distributor shall include in his/her inventory as an importer or exporter only those stocks of controlled substances that are actually separated from his stocks as a manufacturer or as a distributor (e.g, in transit or in storage for shipment).
(B) The number and size of inner liners (e.g, five 10-gallon liners, etc.);
23. Between January 1, 2011, and January 1, 2012, Defendant refused or negligently failed to make, keep, or…
U.S. v. Poulin
On September 27, 1995, two years after the inspections, defendants attached to their opposition to…