Massachusetts law about prescription medication

A compilation of laws, regulations, cases, and web sources on prescription drugs in Massachusetts.

Table of Contents

Massachusetts laws

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.118E, § 13L (added by St.2019, c.82) Hospitals can buy prescription drugs at discounted prices
MGL c.112:

MGL c.175H, § 3 Using prescription drug coupons

Massachusetts regulations

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 and regulations

Federal laws

21 U.S.C. Chapter 9 Federal Food, Drug & Cosmetic Act (FD&C). U.S. Food and Drug Administration

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

Federal regulations 

Title 21 CFR:

  • 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

General information

Drug liability

Selected cases

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.

Web sources

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.

Print sources

Drug product liability. Matthew Bender, loose-leaf

Massachusetts practice v. 10A (Procedural forms annotated), ThomsonWest, with supplement. Section 43:12 - Action against pharmacist - Negligent prescription; Section 43:24 - Action against psychiatrist - Negligent prescription of drugs

Massachusetts practice v. 51 (Professional malpractice), ThomsonWest, with supplement. Section 12.14 - Pharmacists; Section 13.2 - The learned intermediary doctrine

Massachusetts practice v. 52 (The law of chapter 93A), ThomsonWest, with supplement Section 9.29 - Torts --Pharmacist malpractice, pharmacies, and pharmaceutical companies

Physicians' desk reference (PDR). Thomson PDR

PDR Guide to drug interactions, side effects, and indications. Thomson PDR

Pharmacy liability

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

List of Massachusetts drop off locations to dispose of 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.

Contact

Phone

Within Massachusetts only

Within Massachusetts only

Online

Reference librarians online Chat with a law librarian 
Reference librarians via email masslawlib@gmail.com

Address

Administrative office (no law library at this location)
2 Center Plaza
9th Floor
Boston, MA 02108
Last updated: March 11, 2020
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