2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part VI - Enforcement of Subtitle; Prohibited Acts › Section 21-260 - Defenses to Alleged Violations; Burden of Proof

(a)    Except as to an alleged violation that is enumerated under subsection (b)(2) of this section, a person may not be convicted of any violation of this part, if, with respect to the alleged violation, the person establishes by a preponderance of evidence that the person did not commit the alleged violation purposely, knowingly, recklessly, or negligently.
(b)    (1)    A person may not be convicted of any violation of the provisions of this subtitle that are enumerated under paragraph (2) of this subsection, if, with respect to the alleged violation, the person establishes by a preponderance of the evidence that:
(i)    For the purpose of disclosing the possible existence of the violation, the person:
1.    Made an inspection, examination, or test; or
2.    Received a written report that certified the results of an inspection, examination, or test that was made;
(ii)    The inspection, examination, or test and the instruments, personnel, and methods used in connection with it reasonably would be expected to disclose the existence of the violation;
(iii)    The inspection, examination, test, or the written report provided no basis for a belief that the alleged violation existed; and
(iv)    The person did not commit the alleged violation purposely, knowingly, recklessly, or negligently.
(2)    The provisions of paragraph (1) of this subsection apply to any violation of any of the following provisions of this subtitle:
(i)    § 21-256(1) of this subtitle, concerning the manufacture or sale of an adulterated or misbranded article;
(ii)    § 21-256(2) of this subtitle, concerning the adulteration or misbranding of any article;
(iii)    § 21-256(4) of this subtitle, concerning the receipt in commerce of any adulterated or misbranded article;
(iv)    § 21-256(5) of this subtitle, concerning the delivery of any adulterated or misbranded article;
(v)    § 21-258(b)(13) of this subtitle, concerning the failure to identify on a prescription form the name of the prescriber of a drug;
(vi)    § 21-258(b)(14) of this subtitle, concerning the dispensing of a drug on a written prescription that lacks the name of the prescriber; and
(vii)    § 21-258(b)(15) of this subtitle, concerning the provision to the Secretary of information about prescription drugs.
(c)    For purposes of this section, an inspection, examination, or test by representative samples of a lot, delivery, or other mercantile quantity is considered to be a method that reasonably would be expected to disclose the existence of a violation with respect to all of the articles included in the lot, delivery, or other mercantile quantity.
(d)    Unless the person also is the manufacturer, packer, distributor, or seller of the article, a publisher, radio or television broadcast license holder, or other agency or medium for the dissemination of an advertisement is not liable under this subtitle for the dissemination by that person of a false advertisement concerning a food, drug, device, or cosmetic.