Source: https://www.govregs.com/regulations/expand/title21_chapterI_part610_subpartG_section610.61
Timestamp: 2020-08-04 22:56:06
Document Index: 543563882

Matched Legal Cases: ['§ 610', 'art 610', '§ 610', '§ 610', '§ 610', '§ 610', '§ 610', '§ 610', '§ 610', '§ 610', '§ 610', 'art 208', '§ 208', '§ 610', '§ 601', '§ 601', '§ 610', '§ 610', '§ 610', '§ 610', '§ 610', '§ 610', '§ 312']

21 CFR 610.61 - Package label. § 610.61 - Package label.
All TitlesTitle 21Chapter IPart 610Subpart G - Labeling Standards
Collapse to view only § 610.61 - Package label.
§ 610.60 - Container label.
§ 610.61 - Package label.
§ 610.62 - Proper name; package label; legible type.
§ 610.63 - Divided manufacturing responsibility to be shown.
§ 610.64 - Name and address of distributor.
§ 610.65 - Products for export.
§ 610.67 - Bar code label requirements.
§ 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.
(6) The statement: “ ‘Rx only’ ” for prescription biologicals.
(7) If a Medication Guide is required under part 208 of this chapter, the statement required under § 208.24(d) of this chapter instructing the authorized dispenser to provide a Medication Guide to each patient to whom the drug is dispensed and stating how the Medication Guide is provided, except where the container label is too small, the required statement may be placed on the package label.
(s) The statement: “ ‘Rx only’ ” for prescription biologicals.
Labels on packages or containers of products for export may be adapted to meet specific requirements of the regulations of the country to which the product is to be exported provided that in all such cases the minimum label requirements prescribed in § 610.60 are observed.
(1) You need not submit a supplement under § 601.12(f)(1) through (f)(2) of this chapter; however,
(2) You must report any grant of a request for an exception or alternative under this section as part of your annual report under § 601.12(f)(3) of this chapter.
(1) § 610.60;
(2) § 610.61(c) and (e) through (r);
(3) § 610.62;
(4) § 610.63;
(5) § 610.64;
(6) § 610.65; and
(7) § 312.6.