Massachusetts laws
MGL c. 13, §§ 22-25 Board of Registration in Pharmacy
MGL c. 17, § 13 Drug Formulary Commission
MGL c. 94C Controlled Substances Act
- MGL c. 94C, § 18 Issuance of prescription by practitioner or physician
See also: Out-of-state schedule II prescriptions and supervised prescribing - MGL c. 94C, § 34 Unlawful possession of particular controlled substances
MGL c. 94D Controlled substances therapeutic research act
Research into the use of medical marijuana.
MGL c. 112 Registration of certain professions and occupations
- MGL c. 112, § 12D Use of prescriptions of interchangeable drug products (generics)
- MGL c. 112, § 24 Registration of pharmacists
- MGL c. 112, § 39D Report of improper dispensing
- MGL c. 112, § 12H Printing of physician’s name required
- MGL c. 112, § 21A Printing of podiatrist’s name required
- MGL c. 112, § 50A Printing of dentist’s name required
- MGL c. 112, § 56B Printing of veterinarian’s name required
- MGL c. 112, § 66B and § 66C Optometrists
- MGL c. 112, § 80E Nurse practitioners
- MGL c. 112, § 80G Nurse-midwives
- MGL c. 112, § 80H Nurse anesthetists
MGL c. 175H, § 3 Solicitation, improper inducement to use goods, facilities, services, or products covered by insurance (Using prescription drug coupons)
MGL c. 118E, § 13L Restriction of hospital access to discounted purchase of prescription drugs
MGL c. 118E, § 51A Clinical review criteria used to establish step therapy protocol; requests for exceptions to protocol
Step therapy requires patients to try one or more insurer-preferred medications or treatments prior to implementing a physician recommendation.
- 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).
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 721.20 Prescription formats – who can prescribe, and how
- 105 CMR 721.055 Partial filling of prescriptions
105 CMR 722 Dispensing procedures for clinic and hospital pharmacies
247 CMR Board of Registration in Pharmacy
- 247 CMR 5.00 Orally and electronically transmitted prescriptions; prescription monitoring program (PMP) reporting requirements
- 247 CMR 5.03 Emergency situations for dispensing schedule II drugs
- 247 CMR 9.00 Code for professional conduct, professional standards for registered pharmacists, pharmacies, and pharmacy departments
- 247 CMR 9.02 Transferring prescriptions to another pharmacy
958 CMR 12 Drug pricing review
Federal laws, regulations, and executive orders
Federal laws
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
Federal regulations
- Chapter I: Food and Drug Administration, Department of Health and Human Services
- Subchapter C - Drugs: General, Parts 200-299
- New: 21 CFR part 202 Prescription drug advertising
21 CFR 202.1(e)(1): Human prescription drug advertisements on television or radio that state the name of the drug and its conditions of use must present the major statement relating to side effects and contraindications in a clear, conspicuous, and neutral manner.
- New: 21 CFR part 202 Prescription drug advertising
- Subchapter D - Drugs for Human Use, Parts 300-499
- Subchapter C - Drugs: General, Parts 200-299
- Chapter II: Drug Enforcement Administration, Department of Justice: Parts 1300-1321 - Controlled Substances
- Partial filling of prescriptions: 21 CFR 1306.13
- Refilling of prescriptions: 21 CFR 1306.22
- Schedules of controlled substances: 21 CFR 1308
Executive orders
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."
Selected cases
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 a prescription.
Cottam v. CVS Pharmacy, 436 Mass. 316 (2002)
"Learned intermediary doctrine." Only a physician (the "learned intermediary"), 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
Massachusetts web sources
Elements of a written prescription, Mass. Department of Public Health.
Forms of ID accepted at pharmacies to pick up a controlled substance, Massachusetts Board of Registration in Pharmacy News. 2019.
Massachusetts Controlled Substances Registration (MCSR), Drug Control Program.
The MCSR is issued 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 policy on drug interchangeability, Mass. Department of Public Health.
Prescribing practices policy and guidelines, Mass. Board of Registration in Medicine, (2015).
An overview of a physician's responsibilities when prescribing medications, including prescribing to family and friends and internet prescriptions.
Prescription Monitoring Program (PMP), Mass. Department of Public Health.
The PMP tracks statewide Schedule II-V prescriptions in order to give practitioners the tools they need to make the best clinical decisions.
Substance abuse assistance, Mass. Department of Mental Health.
Information on prescription drug addiction.
Federal web sources
Approved drug products with therapeutic equivalence evaluations | Orange book, U.S. Food and Drug Administration.
Controlled substances schedule, U.S. Drug Enforcement Administration.
List of drugs that need a prescription, as well as a list of exemptions.
Drug approvals and databases, U.S. Food and Drug Administration.
Drug safety and availability, U.S. Food and Drug Administration.
Provides information on safety, shortages, and recalls.
Legal requirements for the sale and purchase of drug products containing pseudoephedrine, ephedrine, and phenylpropanolamine, U.S. Food and Drug Administration. Current as of 11/24/2017.
Prescription drug advertising, U.S. Food and Drug Administration.
Products liability and/or professional negligence
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.
Research may be started in one of the Mass. Trial Court Law Libraries, using Westlaw to search "Causes of Action" to determine if you have a good case. Drug Product Liability, a book which is also available at the Trial Court Law Libraries, could be another helpful source. Product liability claims are actions against a drug manufacturer or seller for selling a defective or dangerous product.
You also have may have a professional malpractice claim, in addition to the products liability claim. Medical malpractice is an action against a doctor, nurse or other health care provider or facility for failure to adhere to the professional standard of care for their respective position. Pharmacists have a different role in the dispensing of medications, and they can be held liable as well. Medical malpractice cases in Massachusetts are heard by a Tribunal consisting of a single justice of the Superior Court, a licensed physician, and an attorney, according to Superior Court Rule 73.
Need assistance from a lawyer? See the Finding a lawyer page to find information on different types of free and fee-based legal assistance that is available.
Proper disposal of prescriptions and over-the-counter drugs
Find a waste medication kiosk, Mass. Department of Environmental Protection.
Use either the interactive map or downloadable list to find a kiosk where you can dispose of expired or unneeded prescription drugs.
Safely dispose of prescription drugs, Mass. Department of Environmental Protection.
Find a kiosk or one-day event near you to dispose of prescription drugs that are expired or no longer needed.
Traveling with medications
Airport screening
Information provided by the Transportation Security Administration (TSA) on airport screening processes and which medications and medical supplies are allowed in carry-on and checked luggage.
- Can you pack your meds in a pill case and more questions answered
- Disabilities and medical conditions: medications
Information on pill (or other solid form) and liquid prescription medications. - What can I bring: medical
Includes 4 pages of different types of medications and medical supplies, and traveling instructions for each item.
Additional information
General
- Traveling with medicine, GoodRx.
- Traveling with prescription medications [video], U.S. Food & Drug Administration (FDA)
Traveling abroad
- Traveling abroad with medicine, Centers for Disease Control and Prevention.
Traveling to the U.S.
- 5 tips for traveling to the U.S. with medications, U.S. Food & Drug Administration (FDA)
Contact for Massachusetts law about prescription medication
Online
| Last updated: | November 18, 2024 |
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