Enforcement

The opening words of 21 U.S.C. 352 provide that a drug or device 'shall be deemed to be misbranded' in the listed cases. Section 352(n) provides that a prescription drug is misbranded unless the manufacturer, packer or distributor includes in all advertisements and other descriptive printed matter it issues with respect to that drug a true statement of (1) the established name, printed prominently and in type at least half as large as any trade or brand name, (2) the quantitative formula, and (3) such other information in brief summary relating to side effects, contraindications and effectiveness as the Secretary requires by regulation. Section 331 prohibits (a) the introduction or delivery for introduction into interstate commerce of a misbranded drug, (b) misbranding in interstate commerce, and (c) the receipt in interstate commerce of a misbranded drug and its delivery for pay or otherwise. The chain 'advertising violation to misbranding to prohibited act' therefore holds on the face of the statute. Under 21 U.S.C. 333(a)(1) a violation of section 331 carries up to one year of imprisonment or a fine of up to $1,000 or both, and under 333(a)(2) a violation after a conviction under that section has become final, or one committed with intent to defraud or mislead, carries up to three years or a fine of up to $10,000 or both. However, 18 U.S.C. 3571(e) preserves a lower statutory fine only where the law setting forth the offence 'by specific reference' exempts the offence, and the text of 333(a) contains no such reference. Consequently, under 18 U.S.C. 3559(a) the 333(a)(1) offence is a Class A misdemeanour and the 333(a)(2) offence a Class E felony, and under 18 U.S.C. 3571(b)(3) and (b)(5) and 3571(c)(3) and (c)(5) an individual may be fined up to $250,000 for the felony and up to $100,000 for the Class A misdemeanour not resulting in death, and an organisation up to $500,000 and $200,000 respectively. Section 3571(d) additionally permits a fine of up to twice the gross gain or twice the gross loss.

21 U.S.C. 352 柱書は、同条各号に該当する医薬品等を「虚偽表示（misbranded）」とみなす。同条(n)は、処方薬について、製造業者等が当該医薬品に関して発するすべての広告及び記述的印刷物に、(1)一般的名称（商標等に用いる活字の半分以上の大きさで目立つように印刷）、(2)各成分の定量的処方、(3)長官が規則で定める副作用・禁忌・有効性に関する簡潔な要約を真実に記載しない限り、当該処方薬を虚偽表示とする。21 U.S.C. 331は(a)虚偽表示医薬品の州際通商への導入等、(b)州際通商における虚偽表示、(c)虚偽表示医薬品の州際通商における受領及び引渡しを禁止行為とする。したがって広告義務違反→虚偽表示→第331条の禁止行為という連鎖が条文上成立する。21 U.S.C. 333(a)(1)は第331条違反を1年以下の拘禁又は1,000ドル以下の罰金（併科可）とし、(a)(2)は本条による有罪判決確定後の再違反又は詐欺・誤導の意図による違反を3年以下の拘禁又は10,000ドル以下の罰金（併科可）とする。ただし18 U.S.C. 3571(e)は、実体規定が「specific reference」により本条の適用を除外している場合にのみ低い法定額に留めると定めるところ、333(a)の条文にはそのような明示の除外がない。その結果、18 U.S.C. 3559(a)により333(a)(1)の罪はClass A misdemeanor、333(a)(2)の罪はClass E felonyに分類され、18 U.S.C. 3571(b)(3)(5)・(c)(3)(5)により個人は最大250,000ドル（重罪）／100,000ドル（死亡を伴わないClass A軽罪）、法人等は最大500,000ドル／200,000ドルまで科され得る。さらに3571(d)は、被告人が金銭的利得を得た場合又は他人に金銭的損失を生じさせた場合、総利得又は総損失の2倍までの罰金を認める。