reglab/statecodes huggingface dataset:
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part I - Definitions; Scope and Application of Provisions › Section 21-201 - Definitions

(a)    In this subtitle the following words have the meanings indicated.
(b)    “Counterfeit drug” means a drug that:
(1)    Bears, or the container or labeling of which bears, without authorization, the trademark, trade name, imprint, symbol, or any other identifying mark, or any likeness of any of these markings, of a manufacturer, processor, packer, or distributor other than the one who, in fact, manufactured, processed, packed, or distributed the drug; and
(2)    By use of these markings falsely purports or is represented to be the product of, or to have been packed or distributed by, the other drug manufacturer, processor, packer, or distributor.
(c)    (1)    “Established name” means, in regard to a drug or an ingredient of a drug:
(i)    The name designated under the federal act;
(ii)    If a name has not been designated under the federal act, but the drug or ingredient has been recognized in an official compendium, then the title used in the compendium; or
(iii)    If a name cannot be determined under item (i) or (ii) of this paragraph, the common or usual name of the drug or ingredient.
(2)    In applying the provisions of paragraph (1)(ii) of this subsection, if a drug or an ingredient of a drug is recognized in both the United States Pharmacopoeia and National Formulary and in the Homeopathic Pharmacopoeia of the United States under different official titles, the title used in the United States Pharmacopoeia and National Formulary is the established name, unless the drug is labeled and offered for sale as a homeopathic drug, in which event the official title used in the Homeopathic Pharmacopoeia of the United States is the established name.
(d)    “New drug” means any drug that:
(1)    Among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, is not recognized generally as safe and effective for use under the conditions specified, recommended, or suggested in the labeling of the drug; or
(2)    As a result of investigations to determine its safety and effectiveness for use, has become recognized by these experts as safe and effective under the conditions, but that, other than in the investigations, has not been used to a material extent or for a material time under the conditions.
(e)    “Prescription drug” means a drug that, under § 21-220 of this subtitle, may be dispensed only on the prescription of a health practitioner who is authorized by law to prescribe the drug.
(f)    “State adopted federal rule or regulation” means any rule or regulation that is adopted by the federal government under the federal act and that becomes a rule or regulation by automatic adoption under the provisions of this subtitle.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part I - Definitions; Scope and Application of Provisions › Section 21-202 - Scope of Subtitle

(a)    Any drug that is designated as a “controlled dangerous substance” under Title 5 of the Criminal Law Article is governed by that title as well as by this subtitle.
(b)    If, as to any drug that is a “controlled dangerous substance”, there is any conflict between the provisions of this subtitle and those of Title 5 of the Criminal Law Article, the provisions of the Criminal Law Article apply.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part I - Definitions; Scope and Application of Provisions › Section 21-203 - Application of Label Requirements to Outside Container or Wrapper

If there is an outside container or wrapper for a food, drug, device, or cosmetic, then, to comply with any requirement that is imposed under this subtitle that a word, statement, or any other information appear on the label or the article, the word, statement, or other information also shall:
(1)    Be placed on the outside container or wrapper; or
(2)    Be legible through the outside container or wrapper.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part I - Definitions; Scope and Application of Provisions › Section 21-204 - Construction of Representations That Drug Is Antiseptic

Unless the drug is purported to be an antiseptic for inhibitory use as a wet dressing, ointment, or dusting powder, or as some other substance that involves prolonged contact with the body, the representation of any drug, in its labeling or in an advertisement, as an antiseptic shall be considered to be a representation that the drug is a germicide.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part I - Definitions; Scope and Application of Provisions › Section 21-205 - Imputation of Act or Omission

For purposes of the construction and enforcement of this subtitle, an act or omission of any officer, agent, employee, or any other person acting for or employed by any corporation, company, society, or association, shall be considered to be the act or omission of the corporation, company, society, or association, as well as of the person.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part II - Food › Section 21-207 - Adulterated Food -- in General

(a)    In addition to any other ground that may be applicable under this title, a food is considered to be adulterated for purposes of this subtitle if the standards in this section or in § 21-208 or § 21-209 of this subtitle apply.
(b)    A food is adulterated if:
(1)    It contains any poisonous or otherwise deleterious substance that, in the quantity present, reasonably would be expected to make it injurious to health;
(2)    It contains any added poisonous or added deleterious substance:
(i)    That is not a food or color additive; and
(ii)    The particular use of which has not been found safe as provided under § 21-239 of this subtitle;
(3)    It is or contains any food additive or color additive the particular use of which has not been found safe as provided under § 21-239 of this subtitle;
(4)    Any part of it is a diseased, contaminated, filthy, putrid, or decomposed substance;
(5)    It was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have:
(i)    Contaminated it with filth; or
(ii)    Caused it to be diseased, unwholesome, or injurious to health;
(6)    Any part of its container is composed of any poisonous or otherwise deleterious substance that reasonably would be expected to have caused the food to be injurious to health;
(7)    It has been subjected intentionally to radiation, unless the use of the radiation conforms to that allowed by a rule or regulation under the federal act or under § 21-239 of this subtitle;
(8)    At any time after its manufacturing, processing, or packaging, it was refrozen after having been permitted to thaw from a prior freezing; or
(9)    It otherwise is unfit as food for human beings.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part II - Food › Section 21-208 - Adulterated Food -- Food Components

In addition to any other ground that may be applicable under § 21-207 or § 21-209 of this subtitle, a food is adulterated if:
(1)    Any part of an important component that normally would be present in the food has been omitted or withdrawn from it;
(2)    Any substance has been substituted for any part of an important component that normally would be present in the food;
(3)    Any damage to or inferiority of the food has been concealed in any way; or
(4)    It has had any substance added, mixed, or packed with it solely for any of the following purposes:
(i)    To increase its bulk or weight;
(ii)    To reduce its quality or strength below that which normally would be expected of the food; or
(iii)    To mislead the consumer by making the food appear to be better or more valuable than it is.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part II - Food › Section 21-209 - Adulterated Food -- Confectionary Products

(a)    In addition to any other ground that may be applicable under § 21–207 or § 21–208 of this subtitle, a confectionary food product is adulterated if:
(1)    It contains any nonnutritive object, except as permitted by the rules and regulations adopted under subsection (b)(1) of this section; or
(2)    It contains any nonnutritive substance other than a safe substance:
(i)    That is in or on the confectionery because of some practical functional purpose in the manufacture, packaging, or storing of the confectionery; and
(ii)    The use of which does not promote deception of the consumer or otherwise result in any adulteration or misbranding in violation of this subtitle.
(b)    (1)    If, in the judgment of the Secretary, a nonnutritive object is of practical, functional value to a confectionary food product and its use is not injurious or hazardous to health, the Secretary may adopt a rule or regulation that permits an exception to subsection (a)(1) of this section, regarding nonnutritive objects.
(2)    To avoid or resolve uncertainty, the Secretary may by rule or regulation:
(i)    Interpret subsection (a)(2) of this section as that subsection applies to use of a particular nonnutritive substance; and
(ii)    Allow or prohibit the use of the particular nonnutritive substance.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part II - Food › Section 21-211 - Control of Food Subject to Contamination With Microorganisms

(a)    By the issuance, denial, or suspension of permits as provided in this section, the Secretary may regulate the distribution in this State of any class of food that may be contaminated with microorganisms.
(b)    (1)    The Secretary shall adopt rules and regulations that provide for the issuance of permits to food manufacturers, processors, or packers in any locality if, on investigation, the Secretary finds:
(i)    That the distribution in this State of any class of food manufactured, processed, or packed in that locality may be injurious to health because of possible contamination with microorganisms; and
(ii)    That the danger imposed by the food normally would not be determinable after the food has entered commerce.
(2)    For whatever temporary period of time that may be necessary, the rules and regulations shall specify the conditions necessary to govern the manufacturing, processing, and packing of the class of food in question in order to protect the public from the dangers imposed by that food. These conditions shall be attached to and be considered part of any permit that is issued under this section.
(c)    A person may not introduce or deliver for introduction into commerce in this State any food that was manufactured, processed, or packed by an establishment that was required by rule or regulation adopted under this section to hold a permit, unless each manufacturer, processor, and packer of the food held the required permit.
(d)    (1)    At any reasonable time, a representative of the Secretary may enter any establishment that holds a permit issued under this section and inspect the establishment to determine if it is in compliance with the permit conditions.
(2)    If access for inspection is denied to a representative of the Department who is acting under this subsection, the Secretary may suspend the permit of the establishment involved until access is allowed.
(e)    (1)    If the Secretary finds that an establishment has violated any condition of a permit issued under this section, the Secretary may suspend the permit immediately after giving notice to the permit holder.
(2)    The holder of a suspended permit may apply to the Secretary at any time for reinstatement of the permit.
(3)    On receipt of an application for reinstatement, the Secretary shall hold a hearing and have the establishment inspected.
(4)    If the Secretary finds that adequate measures have been taken to assure compliance with the permit, the Secretary immediately shall reinstate the permit:
(i)    As originally issued; or
(ii)    With any amendment that, under the provisions of this section, the Secretary considers proper.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part II - Food › Section 21-212 - Exemptions From Labeling Requirements for Foods Subject to Additional Processing, Labeling, or Packing

(a)    A food is not subject to the labeling requirements of this subtitle if a rule or regulation is adopted as provided under this section to exempt it.
(b)    Subject to the provisions of § 21-241 of this subtitle, any rule or regulation adopted under the federal act to exempt a food from labeling requirements is effective automatically in this State.
(c)    In addition to the State adopted federal rules and regulations, the Secretary shall adopt rules and regulations to exempt from the labeling requirements of this subtitle any food that is to be transported in substantial quantities from one establishment to another, if:
(1)    In accordance with the practice of the trade, the food is to be processed, labeled, or repacked at the second establishment; and
(2)    The Secretary has a reasonable basis to believe that the food will not be misbranded or adulterated when it is removed from the second establishment.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part II - Food › Section 21-213 - Special Dietary Use Rules and Regulations

(a)    Subject to the provisions of § 21-241 of this subtitle, any special dietary use rule or regulation that is adopted by the federal government under the federal act automatically is adopted as a rule or regulation of this State.
(b)    Whether or not in accordance with any rule or regulation adopted under the federal act, the Secretary may adopt special dietary use rules or regulations if the Secretary finds that it is necessary to inform purchasers of the value of a food for special dietary use.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part II - Food › Section 21-214 - Addition of Alcohol to Food Product

(a)    This subtitle may not be construed to prohibit the addition of alcohol to a food product, including a confectionery and a frozen dessert.
(b)    A food product that is manufactured or sold that contains more than one–half of one percent of alcohol per volume:
(1)    May not be sold to individuals under 21 years of age; and
(2)    Shall state on the label of the food product:
(i)    That the sale of the product to individuals under 21 years of age is prohibited;
(ii)    That the product contains alcohol; and
(iii)    The product’s alcohol percent per volume.
(c)    Subsection (b) of this section may not be construed to limit the application of relevant provisions of the Alcoholic Beverages Article, and regulations adopted under that article, to a manufacturer or seller of a food product regulated under subsection (b) of this section.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part III - Drugs and Devices › Section 21-216 - Adulterated Drugs and Devices

(a)    For purposes of this subtitle, a drug or device is adulterated if the standards in this section apply.
(b)    A drug or device is adulterated if:
(1)    Any part of it is a filthy, putrid, or decomposed substance; or
(2)    It was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have:
(i)    Contaminated it with filth; or
(ii)    Caused it to be injurious to health.
(c)    In addition to the grounds specified in subsection (b) of this section, a drug is adulterated if:
(1)    Any part of its container is composed of any poisonous or otherwise deleterious substance that reasonably would be expected to have caused the drug to be injurious to health;
(2)    For purposes of coloring only, it is or it contains a color additive, the particular use of which has not been found safe as provided under § 21–239 of this subtitle;
(3)    The mixing or packing of any substance with the drug has reduced the quality or strength of the drug;
(4)    Any substance has been substituted for any part of the drug;
(5)    The methods, facilities, or controls used in the manufacture, processing, packing, or holding of the drug do not conform to, or are not administered in conformity to, good practice to assure that the drug:
(i)    Meets the requirements of this subtitle as to safety; and
(ii)    Has the identity, strength, quality, and purity that it purports to have;
(6)    It is purported to be a drug the name of which is recognized in an official compendium and:
(i)    The strength of the drug differs from, or the quality or purity of the drug falls below, the standard set in the official compendium; and
(ii)    The difference in strength, quality, or purity is not stated plainly on its label; or
(7)    Although not purported to be a drug recognized in an official compendium, the strength of the drug differs from, or the quality or purity of the drug falls below that which the drug purports to possess.
(d)    (1)    For purposes of administering subsection (c)(6) of this section, any determination as to whether the strength of a drug differs from or as to whether its quality or purity falls below the standard set in an official compendium shall be made in accordance with the tests or methods of assay set forth in the official compendium, or, in the absence of or inadequacy of those tests or methods of assay, those provided under the federal act.
(2)    (i)    Except as provided in subparagraph (ii) of this paragraph, if a drug is recognized in both the United States Pharmacopoeia and National Formulary and in the Homeopathic Pharmacopoeia of the United States, it is subject to the requirements of the United States Pharmacopoeia and National Formulary.
(ii)    If the drug is labeled and offered for sale as a homeopathic drug, it is subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia and National Formulary.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part III - Drugs and Devices › Section 21-217 - Misbranded Drugs and Devices -- in General

(a)    For purposes of this subtitle, a drug or device is misbranded if the standards in this section or in § 21-218 or § 21-220(d) or (e) of this subtitle apply.
(b)    A drug or device is misbranded if:
(1)    Its labeling is false or misleading in any way;
(2)    Its labeling or packaging does not conform with any provision of § 21-248 of this subtitle;
(3)    It is in package form and it does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor;
(4)    Any word, statement, or other information required under this subtitle to appear on its labeling is not placed prominently on the labeling in a manner that is:
(i)    Conspicuous as compared with other words, statements, designs, or symbols on the labeling; and
(ii)    In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(5)    Its labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device:
(i)    Adequate directions for the use of the drug or device; and
(ii)    Adequate warnings against:
1.    The use of the drug or device by anyone suffering from a pathological condition that may cause its use to be dangerous to health;
2.    The use of the drug or device by a child if its use by a child may be dangerous; and
3.    Unsafe dosages, methods of administration, or duration of administration of the drug or device;
(6)    It is dangerous to health when used in the dosage, with the frequency, or for the duration specified, recommended, or suggested in the labeling of the drug or device; or
(7)    The trademark, trade name, imprint, symbol, or other identifying mark of another drug or any likeness of any of these markings of another drug or device is placed on the drug or device or its container with the intent to defraud.
(c)    (1)    Subsection (b)(5)(i) of this section, which concerns the provision of directions for the use of a drug or device, does not apply to a drug or device that is exempted by:
(i)    A rule or regulation adopted under the federal act; or
(ii)    A rule or regulation adopted by the Secretary under this subsection.
(2)    If the Secretary finds that, as applied to a particular drug or device, any requirement of subsection (b)(5)(i) of this section is not necessary for the protection of the public health, the Secretary shall adopt a rule or regulation to exempt the drug or device from that requirement.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part III - Drugs and Devices › Section 21-219 - Exemptions From Labeling and Packaging Requirements for Drugs and Devices Subject to Additional Processing, Labeling, or Packing

(a)    A drug or device is not subject to the labeling or packaging requirements of this subtitle if a rule or regulation is adopted under the federal act or as provided under this section to exempt it.
(b)    The Secretary shall adopt rules and regulations to exempt from the labeling requirements of this subtitle any drug or device that is to be transported in substantial quantities from one establishment to another, if in accordance with the practice of the trade, the drug or device is to be processed, labeled, or repacked at the second establishment.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part III - Drugs and Devices › Section 21-221 - Label Requirements for Prescription Drugs; Exemption From Provisions on Misbranded Drugs

(a)    A drug that is dispensed under a prescription shall bear a label that states:
(1)    The name and address of the dispenser;
(2)    The serial number of the prescription;
(3)    The date of the prescription or the date that the prescription was filled;
(4)    The name of the prescriber; and
(5)    If stated in the prescription:
(i)    The name of the patient;
(ii)    Any directions for use; and
(iii)    Any cautionary statements.
(b)    If a drug dispensed under a prescription meets the label requirements of this section, it is exempt from the provisions of:
(1)    Section 21-217(b)(3) through (7) of this subtitle; and
(2)    Section 21-218(b)(1) through (4), (7), (8), (13), and (14) of this subtitle.
(c)    The exemptions under this section do not apply to any drug that is dispensed in the course of the conduct of a business of dispensing drugs on the basis of diagnosis made through the mail.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part III - Drugs and Devices › Section 21-222 - Construction of 21-220 and 21-221

Nothing in § 21-220 or § 21-221 of this subtitle relieves any person from any requirement imposed by law with respect to any drug that is classified as a controlled dangerous substance within the meaning of Title 5 of the Criminal Law Article or the applicable federal law.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part III - Drugs and Devices › Section 21-224 - New Drugs -- Exemption When Intended for Investigational Use Only

(a)    (1)    A new drug is not subject to the requirements of § 21-223 of this subtitle if it is exempted by a rule or regulation adopted under this section.
(2)    This section does not require any clinical investigator to submit directly to the Secretary any report on the investigational use of a drug.
(b)    The Secretary shall adopt rules and regulations to exempt from the requirements of § 21-223 of this subtitle any drug that is intended only for investigational use by experts who are qualified by scientific training and experience to investigate the safety and effectiveness of the drug. In addition to any other conditions that may be imposed for the protection of the public health, the rules and regulations may require as a condition for the exemption of a drug that:
(1)    Before any clinical testing of a new drug is undertaken, the manufacturer of the drug or the sponsor of the investigation of the drug submit to the Secretary reports of preclinical tests of the drug, including tests on animals, that are adequate to justify the proposed clinical testing;
(2)    The manufacturer of a new drug that is proposed to be distributed to investigators for clinical testing or the sponsor of the investigation obtain a signed agreement from each investigator who is involved that:
(i)    The patients to whom the drug is administered will be under that investigator’s personal supervision or under the supervision of an investigator who is responsible to that investigator; and
(ii)    The investigator will not supply the drug to any other investigator, or to any clinic, for administration to a human being; and
(3)    The manufacturer of a new drug or the sponsor of the investigation of the drug keep records of, and make reports to the Secretary of, the information obtained from the investigational use of the drug, including analytical reports by investigators, as the Secretary finds will assist in the evaluation of the safety and effectiveness of the drug if an application for the drug is filed under § 21-223 of this subtitle.
(c)    (1)    When adopting a rule or regulation that requires the submission of information under this subsection, the Secretary shall consider the professional ethics of the medical profession and the interests of patients.
(2)    Any rule, regulation, or order under this section shall provide that if any person to whom the rule, regulation, or order applies requests it, and if the Secretary considers it to be appropriate, the person may examine any similar information that is obtained by the Secretary concerning the drug.
(d)    (1)    Any rule or regulation adopted under § 355(i) of the federal act automatically shall be a rule or regulation of this State, as provided in § 21-241 of this subtitle.
(2)    However, the Secretary may adopt a rule or regulation under this section even if it is not in accord with the rules and regulations adopted under the federal act.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part III - Drugs and Devices › Section 21-225 - New Drugs -- Inspection of Records

Any person who is required under § 21-223 or § 21-224 of this subtitle to keep records and any person who is in charge or custody of any of these records, on the request of the Secretary, shall permit the Secretary to have access to, copy, and verify the records at any reasonable time.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part III - Drugs and Devices › Section 21-226 - Printed Information for Use of Practitioners

(a)    The manufacturer, packer, or distributor of any prescription drug that is sold or distributed in this State shall:
(1)    Keep correct copies of any printed matter that is:
(i)    Required to be included in any package in which the drug is sold or distributed; or
(ii)    Approved under the federal act; and
(2)    Send copies of the printed matter to any health practitioner who is authorized to administer the drug and who makes a written request for information about the drug.
(b)    This section does not exempt any person from any labeling requirement imposed under any other provision of this subtitle.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part III - Drugs and Devices › Section 21-227 - Provision of Information on Request of Secretary

On a specific written request by the Secretary, the manufacturer, packer, or distributor of any prescription drug that is sold or distributed in this State shall give the Secretary:
(1)    Any information that the manufacturer, packer, or distributor has about the biological availability and clinical performance of the drug; and
(2)    Any comparative information that the manufacturer, packer, or distributor has about any drug, of the same established name, that is manufactured, packed, or distributed by another person.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part IV - Cosmetics › Section 21-230 - Adulterated Cosmetics

(a)    In Part IV of this subtitle, “hair dye” does not mean eyelash dye or eyebrow dye.
(b)    For purposes of this subtitle, a cosmetic is considered adulterated if:
(1)    Except as provided for coal tar hair dye in subsection (c) of this section, it contains any poisonous or otherwise deleterious substance that, in the quantity present, reasonably would be expected to make it injurious to a user under the conditions of use:
(i)    That are instructed, recommended, or suggested in the labeling or advertisement of the cosmetic; or
(ii)    That are customary or usual for the cosmetic;
(2)    It contains a filthy, putrid, or decomposed substance;
(3)    It was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have:
(i)    Contaminated it with filth; or
(ii)    Caused it to be injurious to health;
(4)    Any part of its container is composed of any poisonous or otherwise deleterious substance that reasonably would be expected to have caused the cosmetic to be injurious to health; or
(5)    It is not a hair dye and it is or it contains a color additive the particular use of which has not been found safe as provided under § 21-239 of this subtitle.
(c)    A coal tar hair dye is not considered adulterated under subsection (b)(1) of this section if it:
(1)    Has on its label a conspicuously displayed warning that states: “Caution -- This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”; and
(2)    Has on its labeling adequate directions for the preliminary testing that is referenced on the label.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part IV - Cosmetics › Section 21-231 - Misbranded Cosmetics

(a)    For purposes of this subtitle, a cosmetic is considered misbranded if:
(1)    Its labeling or packaging is false or misleading in any way;
(2)    It is in package form and it does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor;
(3)    Any word, statement, or other information required under this subtitle to appear on its labeling is not:
(i)    Placed prominently on the labeling so that it is conspicuous, as compared with other words, statements, designs, or symbols, on the labeling; and
(ii)    Expressed in terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use; or
(4)    Except as provided in subsection (b)(1) of this section for color additives to be used in hair dyes, it is a color additive and its packaging and labeling do not meet the applicable requirements of the federal act.
(b)    (1)    A package of color additive is not misbranded under subsection (a)(4) of this section if it is marketed and intended for use only in or on a hair dye.
(2)    A cosmetic that, in accordance with the practice of the trade, is to be processed, labeled, or repacked in substantial quantities at an establishment other than the establishment in which it originally is processed or packed, is exempt from the affirmative labeling requirements of this section while the cosmetic is in transit from the one establishment to the other, if the transit is made for completion only.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part V - State and Federal Rules and Regulations; Administrative Procedures › Section 21-234 - General Rules and Regulations; Application of Administrative Procedure Act

(a)    The Secretary may adopt rules and regulations to carry out the provisions of this subtitle.
(b)    Except for a State adopted federal rule or regulation, the Secretary may not adopt any rule or regulation under this subtitle unless the requirements of this subtitle and the Administrative Procedure Act are met.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part V - State and Federal Rules and Regulations; Administrative Procedures › Section 21-235 - Conformance of State Rules and Regulations; Federal Rules and Regulations

(a)    So far as practicable, the Secretary may conform any rule or regulation adopted under this subtitle to the rules and regulations adopted under the federal act.
(b)    The Secretary may adopt for purposes of this subtitle any rule or regulation adopted by the United States Department of Agriculture.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part V - State and Federal Rules and Regulations; Administrative Procedures › Section 21-236 - Application of Administrative Procedure Act to Hearing

The Secretary shall give notice of and hold any hearing authorized or required by this subtitle in accordance with the Administrative Procedure Act.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part V - State and Federal Rules and Regulations; Administrative Procedures › Section 21-237 - Definitions and Standards of Identity and Quality

(a)    (1)    Except as provided for meat and poultry products under paragraph (3) of this subsection and for frozen desserts under Subtitle 8 of this title, the definitions and standards of identity and quality adopted by rule or regulation under the federal act for foods are the definitions and standards of identity and quality for foods in this State.
(2)    By rule or regulation, the Secretary may adopt a definition or standard of identity or quality for any food if:
(i)    A definition or standard has not been adopted for the food under the federal act; and
(ii)    The Secretary finds that the definition or standard will promote honesty and fair dealing in the interest of consumers.
(3)    Any definition or standard of identity or quality for a meat or poultry product that is adopted under a rule or regulation of the State Department of Agriculture is the definition or standard of identity or quality for that product in this State.
(b)    (1)    For purposes of this subtitle, the standards for the quality, purity, and strength of any drug are the standards set by an official compendium.
(2)    If a drug is not standardized by an official compendium, then subject to § 21-241 of this subtitle, the standards of quality, purity, and strength adopted by rule or regulation under the federal act are the standards of quality, purity, and strength for the drug in this State.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part V - State and Federal Rules and Regulations; Administrative Procedures › Section 21-238 - Authorization by Permit of Exceptions to Definitions and Standards

(a)    If a temporary permit is issued under the federal act to authorize an interstate shipment that varies from the definitions and standards of identity set under the federal act, the permit is effective in this State under the conditions provided in the permit.
(b)    For experimental or other purposes, the Secretary may issue a permit that authorizes variations from the definitions and standards of identity and quality that are set under this subtitle if:
(1)    The Secretary finds that issuance of the permit is in the public interest; and
(2)    The permit is issued on terms and with safeguards that adequately protect the interests of consumers and potential consumers.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part V - State and Federal Rules and Regulations; Administrative Procedures › Section 21-240 - Effective Date and Protest of Rules and Regulations Proposed by Secretary

(a)    Unless a written protest is filed with the Secretary, a rule or regulation proposed by the Secretary under this subtitle takes effect on the date the Secretary designates but not earlier than 90 days after publication.
(b)    Any person who may be affected adversely by a rule or regulation that is proposed by the Secretary under this subtitle may:
(1)    File a protest within 30 days after publication of the proposed rule or regulation; and
(2)    Request a hearing.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part V - State and Federal Rules and Regulations; Administrative Procedures › Section 21-241 - Effective Date and Protest of State Adopted Federal Rules and Regulations

(a)    Unless a written protest is filed with the Secretary, a State adopted federal rule or regulation takes effect in this State on the date that it becomes effective as a federal rule or regulation.
(b)    Any person who may be affected adversely by a State adopted federal rule or regulation may:
(1)    File a protest against the federal rule or regulation not more than 30 days after its effective date; and
(2)    Request a hearing.
(c)    A protest under this section stays the effect of the State adopted federal rule or regulation as a rule or regulation of this State.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part V - State and Federal Rules and Regulations; Administrative Procedures › Section 21-242 - Hearings on Protests of Rules or Regulations

If a written protest against a rule or regulation is filed in accordance with § 21-240 or § 21-241 of this subtitle, the Secretary shall hold a public hearing:
(1)    To receive evidence on the issues raised by the protest; and
(2)    To hear any interested person.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part V - State and Federal Rules and Regulations; Administrative Procedures › Section 21-243 - Orders After Rule or Regulation Protest Hearings

(a)    (1)    As soon as practicable after a hearing on a protest to a rule or regulation under § 21-242 of this subtitle, the Secretary shall:
(i)    Act on the protest by issuing an order; and
(ii)    Send a copy of the order to each protester by certified mail, return receipt requested, bearing a postmark from the United States Postal Service.
(2)    Each order issued under this section shall be based on substantial evidence in the record of the hearing.
(b)    An order issued by the Secretary under this section may:
(1)    Reinstate, rescind, or modify a State adopted federal rule or regulation as a rule or regulation of this State; or
(2)    As to any other rule or regulation proposed under this subtitle:
(i)    Withdraw the proposal;
(ii)    Modify the proposal and set an effective date for the modified proposal that is at least 60 days after publication of the order; or
(iii)    Set a new effective date for the original proposal that is at least 60 days after publication of the order.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part V - State and Federal Rules and Regulations; Administrative Procedures › Section 21-244 - Copies of Statutes; Collecting and Disseminating Information

(a)    The Secretary shall provide a copy of this subtitle and Subtitle 1 of this title:
(1)    To the extent possible, to any person who in this State manufactures, packs, stores, or sells, at wholesale or retail, any food, drug, device, or cosmetic; and
(2)    To any person who requests it.
(b)    The Secretary may:
(1)    Publish summaries of judgments, decrees, or court orders issued under this subtitle;
(2)    Otherwise collect, report, or illustrate the results of any investigation conducted under this subtitle; and
(3)    Disseminate any information regarding any food, drug, device, or cosmetic if the Secretary considers the information necessary for the public health or for the protection of consumers against fraud.
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 21-247 - False Advertising

For purposes of this subtitle, an advertisement for a food, drug, device, or cosmetic is considered to be false if it is false or misleading in any way.
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 21-248 - Particular Representations Regarding Drugs and Devices Considered False Advertisements

(a)    In addition to any finding that may be made under § 21-247 of this subtitle and except as otherwise provided in this section, an advertisement is considered to be false if it represents that a drug or device has any effect regarding albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright’s disease, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, any heart or vascular disease, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), any prostate gland disorder, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia, or any venereal disease.
(b)    If an advertisement for a drug or device is not otherwise considered to be false under § 21-247 of this subtitle, it is not false under this section if:
(1)    It is disseminated only to members of the medical, dental, or veterinary professions;
(2)    It appears only in the scientific periodicals of these professions; or
(3)    It is disseminated only for the purpose of public health education by a person who does not have a direct or indirect commercial interest in the sale of the drug or device.
(c)    (1)    An advertisement for a drug or device is not false under this section if a rule or regulation is adopted that authorizes the advertisement, as provided in this subsection.
(2)    (i)    If the Secretary finds that an advance in medical science has made any type of self-medication safe for the treatment of any disease or disorder named in subsection (a) of this section, the Secretary shall adopt a rule or regulation that authorizes the advertisement of any drug or device that has a curative or therapeutic effect for the disease or disorder.
(ii)    A rule or regulation that authorizes an advertisement is subject to any condition or restriction that the Secretary considers necessary to protect the public health.
(d)    This section does not indicate that self-medication for any disease or disorder other than the diseases and disorders named in subsection (a) of this section is safe or effective.
(e)    Any representation made in the labeling of a drug or device that would be a false advertisement under this section if it appeared elsewhere, is a misbranding of the drug or device under § 21-217 of this subtitle.
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 21-250 - Inspection of Records of Carriers; Use of Evidence Against Carrier Prohibited; Carriers' Exclusion From Other Sections

(a)    For the purpose of enforcing this subtitle and after presentation of appropriate credentials to any person who is in charge of or has custody of the records, the Secretary or a representative of the Secretary may have access to and may copy any record of a carrier in commerce if the record concerns the movement or holding, for commercial purposes, of any food, drug, device, or cosmetic, including information that shows the quantity, shipper, and consignee of the article.
(b)    Any evidence that is obtained under this section may not be used in any criminal prosecution of the person from whom it is obtained.
(c)    A carrier in commerce is not subject to any other provision of this subtitle other than this section simply because the carrier receives, carries, holds, or delivers any food, drug, device, or cosmetic in the usual course of its business as a carrier.
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 21-251 - Analysis of Samples

(a)    If, while conducting an inspection under § 21-249 of this subtitle or while performing any other function under this subtitle, the Secretary obtains a sample of a food or drug, the Secretary may have an analysis or other examination made in a laboratory of the Department to determine:
(1)    As to a food sample, whether the food:
(i)    Is misbranded;
(ii)    Contains any filthy, putrid, or decomposed substance; or
(iii)    Is otherwise adulterated or unfit for food; or
(2)    As to a drug sample, whether the drug:
(i)    Is adulterated; or
(ii)    Is misbranded.
(b)    The results of an analysis or other examination conducted under this section shall be set forth in a written report and a copy of the report shall be given promptly to the owner, operator, or agent in charge of the establishment from which the sample was obtained.
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 21-252 - Injunctive Actions

In addition to and not instead of any other remedy authorized under this subtitle, the Secretary may bring an action to temporarily or permanently enjoin any violation of §§ 21-256 through 21-259 of this subtitle.