St. 2016, c.52 An Act Relative to Substance Use, Treatment, Education and Prevention ("Opioid law")
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.112, § 12H Physicians
MGL c.112, § 21A Podiatrists
MGL c.112, § 50A Dentists
MGL c.112, § 56B Veterinarians
MGL c.112, § 66B Optometrists
MGL c.112, § 80E Nurse Practitioners
MGL c.112, § 80G Nurse-Midwives
MGL c.112, § 80H Nurse Anesthetists
MGL c.175H, § 3 Allows people to use prescription drug coupons (effective 7/1/2012 through 7/1/2015)
St.2014, c.159 Pharmacy Practice. Charges the Board of Registration in Pharmacy with creating new regulations to implement changes regarding licenses, education, labeling, and inspections, and requires these pharmacies to have staffed consumer hotlines during working hours. Compounding pharmacies must also eventually report certain information on the Department of Public Health website for viewing by consumers.
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 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
Federal laws and regulations
21 U.S.C. Chapter 9 Federal Food, Drug & Cosmetic Act (FD&C). U.S. Food and Drug Administration
- 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
- 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.
- Massachusetts Board of Registration in Pharmacy: Policies
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.
- Massachusetts Controlled Substances Registration (MCSR) Overview.
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.
- Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration, 2014
- Prescription Drug Advertising. U.S. Food and Drug Administration
MGL c.90, s.24 Drunk/Drugged Driving
Commonwealth v. Bishop, 78 Mass.App.Ct. 70 (2010), review denied 458 Mass. 1110
On the issue of involuntary intoxication, a judge should instruct the jury that a defendant is entitled to an acquittal if her intoxication was caused solely by her prescription medication, taken as prescribed, and she did not know or have reason to know of the possible effects of the drug on her driving abilities, but the jury can find the defendant guilty if they find that alcohol contributed to her intoxication.
Commonwealth v. Gerhardt, 477 Mass. 775 (2017)
"[T]here is as yet no scientific agreement on whether, and, if so, to what extent, [field sobriety] tests are indicative of marijuana intoxication...Neither a police officer nor a lay witness who has not been qualified as an expert may offer an opinion as to whether a driver was under the influence of marijuana." A police officer may testify, however, about his or her observations, including observations of the defendant's performance on requested behaviors.
Commonwealth v. Reynolds, 67 Mass.App.Ct. 215 (2006), review denied 447 Mass. 1112
Court correctly denied defendant's motion for required finding of not guilty of felony vehicular homicide where there was evidence on the essential element of intoxication that the defendant knew the consequences of taking the prescription drugs she consumed.
Trying OUI Cases in Massachusetts, MCLE, loose-leaf. Chapter 1: Trial Preparation, sections 1.6.5 - OUI of Prescription Drugs, and 1.6.6 - OUI of Alcohol and Prescription Drugs.
Medical-Legal Aspects of Drugs, 2nd ed. Lawyers & Judges Pub., 2007. Chapter 12: "Prosecuting Drugged Driving Cases" (p.168 addresses prescription drugs); Chapter 16: "The Study of Drug Effects on Driving"
Massachusetts Practice v. 12 (Motor Vehicle Law and Practice), ThomsonWest, with supplement. Section 28:36 - Operating under the influence of drugs or alcohol--M.G.L.A. c.90, s.24
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.
Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993)
Court set the standard for admitting expert scientific testimony in a federal trial. There was conflicting expert evidence offered as to whether the ingestion of the prescription antinausea drug, Bendectin, by a mother during her pregnancy caused the adverse effects of limb reduction birth defects suffered by her children.
Commonwealth v. Lanigan, 419 Mass. 15 (1994)
Massachusetts accepted the basic reasoning of Daubert, above, concerning admissibility of scientific evidence.
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.
Drug Product Liability. Matthew Bender, loose-leaf
Litigating the Nursing Home Case. American Bar Association, 2009. Chapter 13: Liability for Prescription Drug Problems
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
Allows use of marijuana for medical purposes.
Barbuto v. Advantage Sales and Marketing, LLC, 477 Mass. 456 (2017)
An employee who has been fired for using medical marijuana off-site, and not before or during work, may sue her employer for handicap discrimination.
105 CMR 725 Implementation of an act for the humanitarian medical use of marijuana
801 CMR 4 Rates
Medical Marijuana in Massachusetts, Mass. Dept. of Public Health
Includes regulations, frequently asked questions, and more
Medical Marijuana, Mass. Medical Society
Links to information on issues for physicians regarding medical marijuana
Medical Marijuana Dispensaries, Mass. Executive Office of Health and Human Services.
Provides the current status and location of all registered medical marijuana dispensaries in Massachusetts.
Disposal of Unused Medicines: What You Should Know. U.S. Food and Drug Administration
Got Drugs? National Take-Back Initiative. U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control
Pharmaceuticals and Personal Care Products. Massachusetts Department of Environmental Protection
Includes information on safely discarding waste medications.
|Last updated:||April 18, 2018|