MGL c.13, §§ 22-25 Board of Registration in Pharmacy
MGL c.94C Controlled substances act
MGL c.94D Controlled substances therapeutic research act (research into the use of medical marijuana)
- MGL c.112, §12D Use of generics
- MGL c.112, § 24 Registration of pharmacists
- MGL c.112, § 39D Report of improper dispensing
- The following sections address who can write prescriptions; need to print name
MGL c.175H, § 3 Using prescription drug coupons
MGL c.118E, § 13L Hospitals can buy prescription drugs at discounted prices
MGL c.118E, § 51A Clinical review criteria used to establish step therapy protocol; requests for exceptions to protocol (Effective October 1, 2023)
- See also: St. 2022, c.254 An act relative to step therapy and patient safety
Insurance providers cannot: make a patient try medications that are known to be either ineffective or cause adverse reactions; make a patient repeat step therapy with the same medication or one in the same pharmacological class; and providers must approve or deny exemption requests and appeals by 3 business days (or in 24 hours in an emergency).
105 CMR 700 Implementation of the Controlled Substances Act (MGL c.94C)
105 CMR 720 List of interchangeable drug products
105 CMR 721 Standards for approved prescription forms (print and electronic) in Massachusetts
105 CMR 722 Dispensing procedures for pharmacists
105 CMR 724 Implementation of the Controlled Substances Therapeutic Research Act (MGL c.94D)
247 CMR Board of Registration in Pharmacy
- 247 CMR 5.03 Emergency situations for dispensing schedule II drugs
- 247 CMR 9.02 Transferring prescriptions to another pharmacy
958 CMR 12 Drug pricing review
Federal laws, regulations, and executive orders
21 U.S.C. 9 Federal Food, Drug & Cosmetic Act (FD&C)
42 U.S.C. 1396o(e) Prohibition of denial of services on basis of individual’s inability to pay certain charges
If you are a Medicaid (MassHealth) recipient, a pharmacy may not refuse to give you your prescription because of an inability to pay
- Chapter I: Food and Drug Administration, Department of Health and Human Services
- Chapter II: Drug Enforcement Administration, Department of Justice: Parts 1300-1321 - Controlled Substances
- Schedules of controlled substances: 21 CFR 1308
Executive Order on promoting competition in the American economy, July 9, 2021.
"(p) The Secretary of Health and Human Services shall: (iv) ... submit a report ... with a plan to continue the effort to combat excessive pricing of prescription drugs and enhance domestic pharmaceutical supply chains, to reduce the prices paid by the Federal Government for such drugs, and to address the recurrent problem of price gouging."
Drug approvals and databases, U.S. Food and Drug Administration.
Drug safety and availability, U.S. Food and Drug Administration.
Portal to information on safety, shortages, and recalls.
Extreme Risk Protection Orders (ERPO)
Procedure for requesting the removal of a person’s license to have or carry a gun. Also known as a red flag law.
Flying with medication
Great explanation from TSA.
Massachusetts Board of Registration in Pharmacy: policies and guidelines
The Board of Registration in Pharmacy publishes these policies in an attempt to clarify statutes and/or regulations which may appear unclear, or which may not lend themselves to varying practice settings.
Massachusetts Board of Registration in Medicine's prescribing practices policy and guidelines (2015)
A comprehensive overview of the physician's responsibilities related to physicians' prescribing practices including prescribing to family and friends, and internet prescriptions.
Massachusetts Controlled Substances Registration (MCSR)
The Drug Control Program issues the Massachusetts Controlled Substances Registration (MCSR) to health care facilities, manufacturers, distributors, community-based programs, and other entities as well as to individual health care providers and researchers. The MCSR provides accountability for the manufacture, distribution, dispensing, possession, prescribing, and administering of controlled substances which, in Massachusetts, includes all prescription drugs.
Massachusetts fact sheet
This fact sheet highlights recent amendments to the MA Controlled Substances Act and also includes other sections of the statute, written in plain English.
Orange book: approved drug products with therapeutic equivalence evaluations, U.S. Food and Drug Administration.
Prescription drug advertising, U.S. Food and Drug Administration.
Substance abuse assistance
Information on prescription drug addiction.
Cottam v. CVS Pharmacy, 436 Mass. 316 (2002)
Court described the "learned intermediary doctrine" wherein a physician acts as a "learned intermediary" between the drug manufacturer or distributor and the consuming patient. As a result, a pharmacy has the duty only to fill the prescription correctly. Only a physician, not a pharmacy or a drug manufacturer, has a duty to warn a customer about a drug's side effects. A pharmacy which voluntarily assumes the duty to warn, however, such as by providing a list of a drug's side effects, must exercise reasonable care. In addition, a pharmacy may have a duty to warn if it has specific knowledge of increased danger to a particular customer, such as filling 2 prescriptions which adversely interact with each other. See, for example, Brienze v. Casserly, 17 Mass.L.Rep. 214 (2003): Court held that the CVS pharmacist had a duty to warn the plaintiff that taking Ciproflaxin and Theophylline together could potentially result in adverse effects.
Rafferty v. Merck & Co., 479 Mass. 141 (2018)
Case discusses the liability of a manufacturer of a brand-name drug for injuries caused by an inadequate warning label on a generic version of the drug. "Applying general principles of tort law and as a matter of public policy, this court concluded that a brand-name drug manufacturer that controls the contents of the warning label on a generic drug, as required by Federal law, owes a duty to consumers of that generic drug not to act in reckless disregard of an unreasonable risk of death or grave bodily injury."
Reckis v. Johnson & Johnson, 471 Mass. 272 (2015).
Failure to warn case involving children's Motrin. Court ruled that damages in excess of $50 million were not excessive.
Product liability claims involving pharmaceutical drugs. Nolo.com.
If you have been injured by a pharmaceutical drug you used, you may have a defective products claim. Pharmaceutical-drug-based product liability claims are similar to other defective product claims, but pharmaceutical-related injury claims have a number of special features, which are discussed below.
Drug product liability, Matthew Bender, loose-leaf.
- vol. 10A (Procedural forms annotated) 6th ed. West, 2009 with supplement, §§ 43:12, 43:24
- vol. 51 (Professional malpractice) Thomson/West, 2007 with supplement, §§ 12:14, 13.2
- vol. 52 (The law of chapter 93A) 2nd ed. Thomson/West, 2007 with supplement, § 9.29
Physicians' desk reference (PDR), Thomson PDR.
Correa v. Schoeck, 479 Mass. 686 (2018)
A pharmacy has "a limited duty to take reasonable steps to notify both the patient and her prescribing physician of the need for prior authorization each time" the patient tries to fill her prescription.
Proper disposal of prescriptions and over-the-counter drugs
Safely dispose of prescription drugs, Dept. of Environmental Protection.
Find a kiosk or one-day event near you to dispose of prescription drugs that are expired or no longer needed.
|Last updated:||November 14, 2022|