C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 206—IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE

21 C.F.R. § 206.10

Code imprint required

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(a) Unless exempted under § 206.7, no drug product in solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product's size, shape, and color, permits the unique identification of the drug product and the manufacturer or distributor of the product. Identification of the drug product requires identification of its active ingredients and its dosage strength. Inclusion of a letter or number in the imprint, while not required, is encouraged as a more effective means of identification than a symbol or logo by itself. Homeopathic drug products are required only to bear an imprint that identifies the manufacturer and their homeopathic nature.

(b) A holder of an approved application who has, under § 314.70 (b) of this chapter, supplemented its application to provide for a new imprint is not required to bring its product into compliance with this section during the pendency of the agency's review. Once the review is complete, the drug product is subject to the requirements of the rule.

(c) A solid oral dosage form drug product that does not meet the requirement for imprinting in paragraph (a) of this section and is not exempt from the requirement may be considered adulterated and misbranded and may be an unapproved new drug.

(d) For purposes of this section, code imprint means any single letter or number or any combination of letters and numbers, including, e.g., words, company name, and National Drug Code, or a mark, symbol, logo, or monogram, or a combination of letters, numbers, and marks or symbols, assigned by a drug firm to a specific drug product.

[58 FR 47958, Sept. 13, 1993, as amended at 60 FR 19846, Apr. 21, 1995; 69 FR 18763, Apr. 8, 2004]
Notes of Decisions
Cited in 4 cases (1 in the last 5 years), 2016–2026 · leading case: State v. LDonna Marie Youmans, 383 P.3d 142 (Idaho Ct. App. 2016).
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State v. LDonna Marie Youmans, 383 P.3d 142 (Idaho Ct. App. 2016). “Under 21 CFR § 206.10 , promulgated under this authority, [ujnless exempted under 206.”
State v. Brazzle, 411 P.3d 1250 (Kan. Ct. App. 2018). · cites it 2× “3d 833 (2017) ("While it may be best practice for an officer to recite his training and experience, such absence is not fatal to an accusatory where the officer specifically identifies the 9 appearance of pills which includes the imprint markings as required by Federal Law [21…”
People v. Spradlin, 56 Misc. 3d 742 (2017). “While it may be best practice for an officer to recite his training and experience, such absence is not fatal to an accusatory instrument where the officer specifically identifies the appearance of pills which includes the imprint markings as required by federal law (21 CFR…”
Cornelius Baskin v. Commonwealth of Kentucky (Ky. 2026). · cites it 2× “See 21 C.F.R. § 206.10 . 21 C.F.R. § 206.10 (a) states: Unless exempted under § 206.”
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