Pharmacy Law: Resources

Maryland State Resources

UMB School of Pharmacy: pharmacy law review course and materials
NABP Pre-MPJE Practice Exam
Maryland Board of Pharmacy home page Visit this page to view publications from the board as well as the latest news. Inspection forms can be found on the "Establishments" page.
Pharmacy Laws and Regulations for the State of Maryland book order form Maryland Pharmacists Association, latest edition. This is a link to order a book containing plain language interpretations of Maryland pharmacy laws and regulations. When you read the interpretations, be sure to review the statutes and regulations in the back of the book that are referred to in the front text.
COMAR 10.34 - Board of Pharmacy Regulations Click on each subtitle section to see an abstract of the subsections, then click on each subsection to read the full text.

Maryland Laws Pertaining to Pharmacy (not an exclusive list):

US Federal Resources

Federal Regulations

Food, Drug, and Cosmetic Act (FD&C Act) U.S. Code of Federal Regulations (CFR) Title 21, Chapter 9 - Federal Food, Drugs, and Cosmetic Act.
Significant Amendments to the FD&C Act Amendments to the FD&C Act dating back to 1980.
Controlled Substances Act U.S. Code of Federal Regulations (CFR) Title 21, Chapter 13 - Drug Abuse Prevention and Control
Code of Federal Regulations, Title 42 - Public Health U.S. Code of Federal Regulations (CFR), Title 42, which provides regulations about public health and welfare.

Browse Federal Resources

DEA Pharmacist's Manual An Informational Outline of the Controlled Substances Act, prepared by the DEA's Diversion Control Division.
Drug Enforcement Administration (DEA) Diversion Control Division Website of the DEA's Diversion Control Division. Contains information and resources about reporting, drug disposal, controlled substance schedules, and more.
U.S. Food & Drug Administration (FDA) website - Drugs The portion of the FDA website focusing on the regulation of drugs.
Poison Prevention Packaging: A Guide for Healthcare Professionals A guide related to the Poison Prevention Packaging Act administered by the U.S. Consumer Product Safety Commission.
United States Pharmacopeia (USP) website The USP develops quality standards for the manufacture of drugs and supplements.
USP <795> FAQs: Pharmaceutical Compounding - Nonsterile Preparations FAQs on USP Compounding Standards General Chapter
USP <797> FAQs: Pharmaceutical Compounding – Sterile Preparations FAQs for USP Compounding Standards General Chapter
USP <800> FAQs: Hazardous Drugs – Handling in Healthcare Settings FAQs for USP Compounding Standards General Chapter
CMS Pharmacist Center Information for pharmacists from the Centers for Medicare & Medicaid Services (CMS).

Search Federal Resources

Search by Citation - United States Code (law) or Code of Federal Regulations (CFR) If you have a citation that looks like-- 21 U.S.C. §801 (United States Code); or 21 C.F.R. §1300.01 (Code of Federal Regulations) you can can retrieve the cite. Click link above, select which legal collection ("United States Code" or "Code of Federal Regulations") you want to search. Under Year, select "Most Recent"; enter Title Number ("21" in this example); and enter Section Number (the number after § symbol). Leave other fields, such as Part or Subpart, blank. Click Retrieve Document.
Advanced Search - United States Code (law) or Code of Federal Regulations (CFR) Under Available Collections select which legal collection you want to search, United States Code, or Code of Federal Regulations, then click Add. USC: To search only Title 21 - Food and Drugs, select "US Code Title Number" and type "21" in search box. CFR: To search only Title 21 - Food and Drugs, select "CFR Title Number" and type "21" in search box. Next, click "Add more search criteria"at the bottom to add more search boxes to input your text search. Click Search. AFTER you get search results page, click any link stating, "Show only recent editions" to retrieve only the most recent laws or regulations.
Tips for Searching the Code of Federal Regulations (CFR)
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations Search the listing of drug products the Food and Drug Administration (FDA) has approved for use under the Federal Food, Drug, and Cosmetic Act, and locate information about therapeutic equivalence.

Pharmacy Law: Resources

Maryland State Resources

US Federal Resources

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