Maryland Statutes
Health - General
Title 21 - Food, Drugs, and Cosmetics

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...

Section 21-213 - Special Dietary Use Rules and Regulations - (a) Subject to the provisions of § 21-241 of this...

Section 21-214 - Addition of Alcohol to Food Product - (a) This subtitle may not be construed to prohibit the...

Part III - Drugs and Devices

Section 21-216 - Adulterated Drugs and Devices - (a) For purposes of this subtitle, a drug or device...

Section 21-217 - Misbranded Drugs and Devices -- in General - (a) For purposes of this subtitle, a drug or device...

Section 21-218 - Additional Grounds of Drug Misbranding - (a) In this section, “antibiotic drug” means any drug that:...

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...

Section 21-220 - Prescription Requirements - (a) A drug that is intended for use by human...

Section 21-221 - Label Requirements for Prescription Drugs; Exemption From Provisions on Misbranded Drugs - (a) A drug that is dispensed under a prescription shall...

Section 21-222 - Construction of 21-220 and 21-221 - Nothing in § 21-220 or § 21-221 of this subtitle...

Section 21-223 - New Drugs -- in General - (a) This section does not apply to any drug that:...

Section 21-224 - New Drugs -- Exemption When Intended for Investigational Use Only - (a) (1) A new drug is not subject to the...

Section 21-225 - New Drugs -- Inspection of Records - Any person who is required under § 21-223 or §...

Section 21-226 - Printed Information for Use of Practitioners - (a) The manufacturer, packer, or distributor of any prescription drug...

Section 21-227 - Provision of Information on Request of Secretary - On a specific written request by the Secretary, the manufacturer,...

Part IV - Cosmetics

Section 21-230 - Adulterated Cosmetics - (a) In Part IV of this subtitle, “hair dye” does...

Section 21-231 - Misbranded Cosmetics - (a) For purposes of this subtitle, a cosmetic is considered...

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...

Section 21-235 - Conformance of State Rules and Regulations; Federal Rules and Regulations - (a) So far as practicable, the Secretary may conform any...

Section 21-236 - Application of Administrative Procedure Act to Hearing - The Secretary shall give notice of and hold any hearing...

Section 21-237 - Definitions and Standards of Identity and Quality - (a) (1) Except as provided for meat and poultry products...

Section 21-238 - Authorization by Permit of Exceptions to Definitions and Standards - (a) If a temporary permit is issued under the federal...

Section 21-239 - Authorization for the Use of Added Poisonous or Otherwise Deleterious Substances, Food Additives, and Color Additives - (a) (1) For purposes of §§ 21-207(b)(3), 21-216(b)(2), and 21-230(b)(5)...

Section 21-240 - Effective Date and Protest of Rules and Regulations Proposed by Secretary - (a) Unless a written protest is filed with the Secretary,...

Section 21-241 - Effective Date and Protest of State Adopted Federal Rules and Regulations - (a) Unless a written protest is filed with the Secretary,...

Section 21-242 - Hearings on Protests of Rules or Regulations - If a written protest against a rule or regulation is...

Section 21-243 - Orders After Rule or Regulation Protest Hearings - (a) (1) As soon as practicable after a hearing on...

Section 21-244 - Copies of Statutes; Collecting and Disseminating Information - (a) The Secretary shall provide a copy of this subtitle...

Part VI - Enforcement of Subtitle; Prohibited Acts

Section 21-247 - False Advertising - For purposes of this subtitle, an advertisement for a food,...

Section 21-248 - Particular Representations Regarding Drugs and Devices Considered False Advertisements - (a) In addition to any finding that may be made...

Section 21-249 - General Powers to Inspect; Taking of Samples - (a) (1) For the purpose of enforcing this subtitle and...

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...

Section 21-251 - Analysis of Samples - (a) If, while conducting an inspection under § 21-249 of...

Section 21-252 - Injunctive Actions - In addition to and not instead of any other remedy...

Section 21-253 - Detainment and Destruction of Articles - (a) Under this section, there is a ground for action...

Section 21-254 - Action Against Food That Poses Immediate Threat - (a) (1) For purposes of this section, an “immediate threat”...

Section 21-255 - Reporting of Criminal Violations - (a) Except as otherwise provided in this section, the Secretary...

Section 21-256 - Prohibited Acts -- General Provisions - A person may not: (1) Manufacture or sell any food,...

Section 21-257 - Violation of Label and Packaging Requirements for Consumer Commodities - (a) Except to the extent that the person is engaged...

Section 21-258 - Prohibited Acts -- Drugs and Devices - (a) In this section, “counterfeit marking tool” means any punch,...

Section 21-259 - Prohibited Acts -- False Reports; Misuse of Information - A person may not: (1) Make a written report that...

Section 21-259.1 - Prohibited Acts -- Opening Closed Food Container - (a) A person may not open a sealed, closed, or...

Section 21-259.2 - Prohibition on Certain Ingredients Knowingly Included in Cosmetic Products - ** TAKES EFFECT JANUARY 1, 2025 PER CHAPTER 490 OF...

Section 21-259.3 - Animal Testing Prohibited in Development of Cosmetic -- Inapplicable to Certain Animal Testing -- Local Law on Animal Testingprohibited -- Civil Penalties -- Enforcement - (a) (1) In this section the following words have the...

Section 21-260 - Defenses to Alleged Violations; Burden of Proof - (a) Except as to an alleged violation that is enumerated...

Section 21-261 - Abatement Orders - (a) If the Department believes that a person is violating...

Part VII - Short Title

Section 21-263 - Short Title - This subtitle may be cited as the “Maryland Food, Drug,...

Subtitle 2A - Prescription Drug Monitoring Program

Section 21-2A-01 - Definitions - (a) In this subtitle the following words have the meanings...

Section 21-2A-02 - Program - (a) There is a Prescription Drug Monitoring Program in the...

Section 21-2A-03 - Implementation and Operation; Prescription Monitoring Data - (a) The Department shall implement the Program, subject to the...

Section 21-2A-04 - Regulations - (a) The Secretary, in consultation with the Board, shall adopt...

Section 21-2A-04.1 - Registration of Prescribers With Program - (a) A prescriber shall be registered with the Program before...

Section 21-2A-04.2 - Prescription Monitoring by Prescribers - (a) (1) Beginning July 1, 2018, a prescriber: (i) Shall...

Section 21-2A-04.3 - Authorization of Prescriber Delegate or Pharmacist Delegate to Request Prescription Monitoring Data - A prescriber or pharmacist may authorize a prescriber delegate or...

Section 21-2A-05 - Advisory Board - (a) There is an Advisory Board on Prescription Drug Monitoring...

Section 21-2A-06 - Prescription Monitoring Data - (a) Prescription monitoring data: (1) Are confidential and privileged, and...

Section 21-2A-07 - Technical Advisory Committee - (a) There is a technical advisory committee to the Program....

Section 21-2A-08 - Liability - (a) With respect to the administration and operation of the...

Section 21-2A-09 - Violations - (a) A dispenser who knowingly fails to submit prescription monitoring...

Subtitle 2B - Right to Try Act

Section 21-2B-01 - Definitions - (a) In this subtitle the following words have the meanings...

Section 21-2B-02 - Providing Investigational Drug, Biological Product, or Device - (a) A manufacturer of an investigational drug, biological product, or...

Section 21-2B-03 - Actions Prohibited if Based on Recommendation Regarding Access to or Treatment With an Investigational Drug, Biological Product, or Device - (a) A health occupations board may not revoke, fail to...

Section 21-2B-04 - Blocking Access by Official, Employee, or Agent of the State Prohibited - (a) An official, employee, or agent of the State may...

Section 21-2B-05 - Private Cause of Action Not Created - This subtitle does not create a private cause of action...

Section 21-2B-06 - Health Insurance Coverage Not Affected - This subtitle does not affect the coverage requirements under Title...

Subtitle 2C - Prescription Drug Affordability Board

Section 21-2C-01 - Definitions - (a) In this subtitle the following words have the meanings...

Section 21-2C-02 - Prescription Drug Affordability Board - (a) (1) There is a Prescription Drug Affordability Board. (2)...

Section 21-2C-03 - Membership - (a) (1) The Board consists of the following members, who...

Section 21-2C-04 - Prescription Drug Affordability Stakeholder Council - (a) There is a Prescription Drug Affordability Stakeholder Council. (b)...

Section 21-2C-05 - Disclosure of Conflicts of Interest - (a) (1) A conflict of interest shall be disclosed: (i)...

Section 21-2C-06 - Acceptance of Gratuities Prohibited - Members and alternate members of the Board, Board staff, and...

Section 21-2C-07 - Study and Report -- Pharmaceutical Distribution and Payment System in State; Policy Options Used in Other States and Countries - On or before December 31, 2021, the Board, in consultation...

Section 21-2C-08 - Collection, Review, and Use of Transparency Data for Prescription Drug Products - (a) On or before December 31, 2021, the Board shall:...

Section 21-2C-09 - Cost Review of Prescription Drug Products With Affordability Challenges - (a) (1) After identifying prescription drug products as required by...

Section 21-2C-10 - Confidentiality - (a) All information and data obtained by the Board under...

Section 21-2C-11 - Funding Source - (a) In this section, “Fund” means the Prescription Drug Affordability...

Section 21-2C-12 - Enforcement - The Office of the Attorney General may pursue any available...

Section 21-2C-13 - Drafting Action Plan for Implementing Process to Set Upper Payment Limits for Prescription Drug Products - (a) On or after January 1, 2022, the Board may...

Section 21-2C-14 - Setting Upper Payment Limits for Prescription Drug Products - (a) On or after January 1, 2022, the Board, in...

Section 21-2C-15 - Appeals of Board Decisions - (a) A person aggrieved by a decision of the Board...

Section 21-2C-16 - Board and Stakeholder Council Report and Recommendation Concerning Upper Payment Limits - On or before December 1, 2023, the Board, in consultation...

Subtitle 3 - Food Establishments

Part I - Definitions; General Provisions

Section 21-301 - Definitions - (a) In this subtitle the following words have the meanings...

Section 21-302 - Scope of Subtitle - This subtitle does not apply to the manufacture of milk,...

Section 21-303 - Purpose of Subtitle - The purpose of this subtitle is to provide that all...

Section 21-304 - Rules and Regulations; Local Legislation; Applicability of Subtitle to Home Rule and Charter County or Baltimore City - (a) (1) The Department shall adopt rules and regulations necessary...

Section 21-304.1 - Written Notice of Intention to Serve Food to Public - (a) A volunteer fire company that meets the requirements of...

Section 21-304.2 - Outdoor Dining -- Allowing Dogs With Patrons - (a) A restaurant with an outdoor dining area may allow...

Part II - Licensing

Section 21-305 - License Required; Restrictions on Licenses; County Licenses - (a) Except as otherwise provided in this subtitle, a person...

Section 21-306 - Applications for License - (a) To apply for a license, an applicant shall submit...

Section 21-307 - Qualifications of Applicants; Inspections - (a) To qualify for a license, an applicant shall: (1)...

Section 21-308 - License Fees - (a) In this section, “on–farm home processing facility” means a...

Section 21-309 - Term and Renewal of License - (a) (1) In this section the following terms have the...

Section 21-309.1 - Producer Mobile Farmer's Market License - (a) (1) The Department shall establish a producer mobile farmer’s...

Section 21-309.2 - Seasonal Farmer's Market Producer Sampling License - (a) A county may establish a seasonal farmer’s market producer...

Section 21-310 - Issuance and Scope of License - (a) Within 30 days after the Department receives an application...

Section 21-311 - Denial of Application for License; Subsequent Issuance of License; Hearings and Judicial Review - (a) The Department may deny an application for a food...

Section 21-312 - Display of License - Each licensee shall display the license conspicuously in the food...

Section 21-312.1 - Licensing Information in Advertisements and Contracts for Catering Services - (a) (1) In this section the following words have the...

Section 21-312.2 - Semipermanent Food Service Facility - (a) This section applies to a semipermanent food service facility...

Part III - Enforcement and Inspection

Section 21-313 - Inspections - (a) To enforce this subtitle, a representative of the Department,...

Section 21-314 - Notice of Violation of Subtitle, Unsanitary Conditions, Etc - If the Department finds that a food establishment is in...

Section 21-315 - Suspension or Revocation of License - The Department may suspend or revoke a license issued under...

Section 21-316 - Hearings - (a) Except as otherwise provided in Title 10, Subtitles 2...

Section 21-317 - Judicial Review - (a) Any person aggrieved by a final decision of the...

Section 21-318 - Order to Abate Violation of Subtitle or Regulation Adopted Thereunder - (a) If the Department believes that a person is violating...

Part IV - Miscellaneous Provisions

Section 21-321 - Construction, Remodeling, or Alterations - (a) Except as provided in subsection (d) of this section,...

Section 21-322 - Donated Food - (a) The Maryland Department of Health and the State Department...

Section 21-323 - Small Residential Group Homes for Children - (a) In this section, “group home” means a foster home,...

Section 21-323.1 - Bed and Breakfast Establishments - (a) In this section, “bed and breakfast establishment” means a...

Section 21-324 - Cleanliness of Certain Premises and Vehicles; Unclean or Unsanitary Conditions - (a) (1) The floors, walls, ceilings, sidewalks, furniture, receptacles, implements,...

Section 21-324.1 - Open Windows and Doors in Food Service Facilities - (a) This section does not apply to an outer door...

Section 21-325 - Restrooms Required in Certain Places - (a) Each food establishment shall have: (1) A convenient toilet...

Section 21-326 - Diagram or Illustrative Directions on Use of Manual Maneuvers to Prevent Asphyxiation Due to Choking - (a) Each food service facility which prepares food and provides...

Section 21-327 - Sleeping Prohibited on Certain Premises - A person may not sleep in: (1) Any workroom or...

Section 21-328 - Employees With Communicable Diseases - (a) A person may not knowingly employ any individual to...

Section 21-329 - Labeling of Surimi Products Required - (a) Unless the packaging of a food product is clearly...

Section 21-330 - Low Calorie Frozen Desserts - (a) A low calorie frozen dessert that contains powders or...

Section 21-330.1 - Cottage Food Businesses - (a) This section does not: (1) Apply to a food...

Section 21-330.2 - Food Allergy Awareness Posting Requirement - (a) Beginning March 1, 2014, a food establishment shall display...

Part V - Soft Drinks

Section 21-332 - Renewal, Denial, Suspension, or Revocation of Registration - The Department shall renew, deny, suspend, or revoke a soft...

Section 21-333 - Sale of Unregistered Soft Drinks Manufactured Outside of State Prohibited - In this State, a person may not sell a soft...

Section 21-334 - Cleaning Soft Drink or Bottled Water Containers - (a) This section applies to any container that is used...

Section 21-335 - Metal or Composite Soft Drink Containers With Detachable Metal Tab Devices - (a) A person may not sell or offer for sale...

Section 21-336 - Drinking Water - (a) (1) In this section, “approved source” means a source...

Section 21-336.1 - Bottled Water - (a) Except as permitted under subsection (b) of this section,...

Part VI - Crab Meat

Section 21-339 - Markings on Containers of Crab Meat; Repacking Crab Meat - (a) In this section, “repack crab meat” means to take...

Section 21-340 - Compliance With Standards Required - All crab meat sold in this State, whether processed in...

Section 21-341 - Misrepresentations and Sale or Possession of Unfit Crab Meat Prohibited - (a) A person may not process, sell, or keep for...

Section 21-343 - Seizure and Condemnation of Certain Crab Meat by Secretary - The Secretary shall seize and condemn any crab meat that...

Part VII - Shellfish

Section 21-346 - Importing Shellfish Prohibited; Exception - Except for shellstock that is imported into this State for...

Section 21-347 - Importing Food Containing Shellfish Prohibited - (a) Unless the shellfish contained in the food comes from...

Section 21-348 - Processing, Sale, or Storage for Sale of Food Containing Shellfish From Unknown or Uncertified Source Prohibited - A person may not process, sell, or keep for sale...

Section 21-349 - Powers of Department - The Department may: (1) Detain and take any necessary action...

Section 21-350 - Shellfish or Processed Crabs to Be Maintained at Temperatures Established by the Department - (a) (1) Any vehicle that is used to transport, store,...

Subtitle 4 - Milk Products

Part I - Definitions; General Provisions

Section 21-401 - Definitions - (a) In this subtitle the following words have the meanings...

Section 21-402 - Legislative Findings - The General Assembly finds that statewide laws, rules, and regulations...

Section 21-403 - Scope of Subtitle - This subtitle applies only to milk products that are intended...

Section 21-404 - State Preemption - (a) A political subdivision may not regulate any milk product...

Section 21-405 - Subtitle to Be Interpreted in Accordance With Grade a Pasteurized Milk Ordinance and Milk for Manufacturing Purposes and Its Production and Processing: Recommended Requirements - (a) Except as otherwise provided in this subtitle or by...

Section 21-406 - Secretary to Adopt Rules and Regulations - The Secretary shall adopt rules and regulations to carry out...

Section 21-407 - Disposition of Funds - The Secretary shall pay all funds collected under this subtitle...

Part II - Permit Process

Section 21-410 - Permit Required; Exceptions; Classifications of Permits - (a) Except as otherwise provided in this section, a person...

Section 21-411 - Qualifications of Applicants - (a) To qualify for a permit, a person shall comply...

Section 21-412 - Applications for Permits - An applicant for a permit shall: (1) Submit an application...

Section 21-413 - Required Inspections - (a) If the property of the applicant is in the...

Section 21-414 - Certified Industry Dairy Farm Inspectors - (a) The Secretary shall certify industry personnel as certified industry...

Section 21-415 - Issuance of Permit - (a) The Secretary shall issue the appropriate permit to any...

Section 21-416 - Scope of Permits - (a) While it is effective, a bobtailer permit authorizes the...

Section 21-416.1 - Farmstead Cheese Program - (a) The Secretary may establish a farmstead cheese program after...

Section 21-417 - Term, Renewal, and Nontransferability of Permits - (a) (1) Except for a milk producer permit, a permit...

Section 21-418 - Suspension and Revocation of Permits - (a) Subject to the hearing provisions of § 21-419 of...

Section 21-419 - Hearings - (a) Except as otherwise provided in this subtitle and in...

Part III - Standards and Handling Requirements for Milk Products

Section 21-422 - Standards for Milk - (a) The raw milk that a milk producer sells shall...

Section 21-424 - Labeling of Milk Products Generally - (a) After the milk product has been processed, each milk...

Section 21-425 - Standards for and Labeling of Condensed Milk, Condensed Skimmed Milk, and Dry Milk Solids - (a) (1) In this section the following words have the...

Section 21-426 - Grade a Milk Product Dating - (a) In this section, “sell-by period” means the length of...

Section 21-427 - Handling of Milk Products - (a) Unless the transfer occurs on a dairy farm or...

Section 21-428 - Impoundment of Mishandled Milk Products; Order to Stop Sale - (a) (1) The Secretary shall impound a milk product that...

Section 21-429 - Sale of Grade a Milk Products From Outside Departmental Inspection Area - (a) If a Grade A milk product is from a...

Section 21-430 - Milk Emergency; Sale of Milk Products Not Certified Grade A - (a) In this section, “milk emergency”: (1) Means a general...

Part IV - Prohibited Acts

Section 21-433 - Violation of Subtitle or Rules and Regulations Adopted Under Subtitle - A person may not violate any provision of this subtitle...

Section 21-434 - Sale of Raw Milk or Farmstead Cheese - Except for sale of raw milk by a holder of...

Section 21-435 - Handling Milk by Individuals With Disease, Cuts, or Lesions Prohibited - (a) (1) An individual who has a communicable disease or...

Section 21-436 - Milk Cans - (a) In this section, “labeled milk can” means any milk...

Subtitle 8 - Frozen Desserts

Part I - Definitions; General Provisions

Section 21-801 - Definitions - (a) In this subtitle the following words have the meanings...

Section 21-802 - Construction of Subtitle - (a) If there is an outside container or wrapper for...

Section 21-803 - Copies of Statutes; Collecting and Disseminating Information - (a) The Secretary shall provide a copy of this subtitle:...

Section 21-804 - Rules and Regulations - (a) To prevent deception in the sale of frozen desserts...

Part II - Licensing

Section 21-807 - License Required - (a) A person shall be licensed by the Secretary before...

Section 21-808 - Application for Licenses; Fees - (a) An applicant for a license shall: (1) Submit an...

Section 21-809 - Inspections; Qualifications for Plants Outside State - (a) If an application is submitted for a license for...

Section 21-810 - Issuance of License - The Secretary shall issue a license to any applicant who...

Section 21-811 - Scope of License - While it is effective, a license authorizes the licensee to...

Section 21-812 - Term, Renewal, and Nontransferability of Licenses - (a) A license expires on the first anniversary of its...

Section 21-813 - Notice of Violations; Suspensions and Revocations - (a) If the Secretary finds that a licensee has violated...

Section 21-814 - Hearings - (a) Except as otherwise provided in the Administrative Procedure Act,...

Section 21-815 - Judicial Review - (a) Any applicant who has been denied a license and...

Part III - Prohibited Acts

Section 21-818 - Manufacturing Without License - A person may not manufacture for sale in this State...

Section 21-819 - Manufacturing on Invalid License; Injunction Against Repeated Offenses - (a) A person may not manufacture for sale in this...

Section 21-820 - Sale of Products From Unlicensed Plant - (a) A person may not sell any frozen dessert or...

Section 21-821 - Sale of Product for Which Frozen Dessert Standard Not Set - (a) Any frozen dessert manufacturer licensed by the State of...

Subtitle 11 - Miscellaneous Drug and Cosmetic Provisions

Part III - General Limitations on Sale or Distribution of Drugs and Cosmetics

Section 21-1110 - Auction Sale of Drugs, Medicine, or Cosmetics - (a) This section does not apply to cosmetics, infant formula,...

Section 21-1111 - Medicine or Patent Medicine Shows - (a) This section does not apply to any: (1) Surgical...

Section 21-1112 - Impoundment of Drugs or Prescription Records of a Permit Holder or Authorized Prescriber - (a) (1) In this section the following terms have the...

Section 21-1113 - Defenses in Actions Related to Health-Related Products - In any action brought by the Attorney General under §...

Subtitle 12 - Penalties

Section 21-1202 - Violation of 21-436 of This Title - (a) A person who violates any provision of § 21-436...

Section 21-1203 - Violation of Subtitle 4, Except 21-425 and 21-436 of This Title - A person who violates any provision of Subtitle 4, except...

Section 21-1204 - Violation of 21-820 or 21-1111 of This Title - (a) A person who violates any provision of § 21–820...

Section 21-1205 - Violation of 21-819 of This Title - (a) A person who violates § 21-819 of this title...

Section 21-1206 - Violation of 21-818 and 21-1110 of This Title - A person who violates any provision of the following sections...

Section 21-1210 - Violation of 21-425 of This Title - A person who violates any provision of § 21-425 of...

Section 21-1212 - Violation of 21-1112 of This Title - A person who violates any provision of § 21–1111 of...

Section 21-1214 - Violation of Subtitle 3 of This Title - (a) (1) Except as provided in paragraph (2) of this...

Section 21-1215 - Violation of Subtitle 2 of This Title - (a) This section does not apply to a violation of...

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Maryland Statutes Health - General Title 21 - Food, Drugs, and Cosmetics

Maryland Statutes
Health - General
Title 21 - Food, Drugs, and Cosmetics