State Regulation of Compounding Pharmacies: State By State Summary of Laws

December 18, 2012
In October 2012, national headlines reported a meningitis outbreak of epidemic proportions. The cause was quickly identified as contaminated compounded injectable medication made by a commercial "compounding pharmacy" located in Massachusetts.

Compounding pharmacies are a long-standing yet less frequently discussed element in the complex matrix of prescription drug manufacturing, distribution and patient use. The term refers to any physical pharmacy that is licensed to mix or "compound" chemical ingredients into a finished medication ready to use by an individual patient, based on a prescription ordered by a physician or other legally authorized prescriber.

The federal Food and Drug Administration (FDA) regulates virtually all commercial pharmaceutical manufacturing. However, states are the primary regulator of pharmacies, including community "drug stores," large chains, in-store pharmacy counters and specialty pharmacies.

State Roles

Every state has laws and regulations guiding pharmacy standards and requirements, addressing issues such as required licenses for each facilty and for the credentialed pharmacists and other employees who work there. Virtually every jurisdiction also has requirements for secure storage, recordkeeping, the forms or pads used for patient prescriptions, labeling, and safety protocols related to origins, authenticity, chain of custody, expiration dates of products, purity, sterility and storage, among others. This includes the extra, explicit authority granted to "compound" or mix pharmaceutical ingredients into a patient-ready product. Numerous existing pharmacies have the authority to prepare such products for patients, based on prescriptions written by doctors or other prescribers. Some of these practice requirements have origins dating back 30 to 50 years, when large drug manufacturers played a much smaller role as the source of medication. State rules are updated periodically, commonly under the jurisdction of individual state Boards of Pharmacy, which operate in the 50 states.

The Recent Issues

The urgent issues that emerged in late 2012 have an additional emphasis. These include:

• Compounding or manufacturing: Is it clear which compounded drug orders meet the state-regulated standard and which cross into a manufacturing regulatory category?
• Definitions: Uniform and up-to-date definitions of compounding, wholesale, specialty and hospital-based pharmacies. Clear language about "sterile" and "non-sterile" compounding.
• Inspection of facilities: How often, by whom, under what conditions. What kind of independent accreditation or evaluation is in place?
• Enforcement: Which agencies or boards, state or federal, take action when violations or omissions occur? What levels of penalties are in place? Who can order the closure of an operating pharmacy?
• Funding: Inspection and enforcement agencies have varied levels of budgets and personnel to complete inspections and enforcement.
• Transparency: Are records of inspections publicly or adequately available to policymakers and federal and state regulatory entities?

Resources:

• CDC Health Alert- Multistate Outbreak of Meningitis and Stroke Associated with Potentially Contaminated Steroid Medication. - Updates and resources from the Centers for Disease Control and Prevention. CDC reports that the Massachusetts Fungal infection outbreak has 620 reported cases across 19 states, with 39 deaths, as of December 17, 2012.
• A background brief, "Pharmacy compounding – regulatory issues" - Essay by Carol Lam, PharmD, Kaiser-Permanente; posted by USC (5 pp-PDF)
• IACP- Compounding for Office-Use – legal database published by International Academy of Compounding Pharmacists © 2012
• State Compounding Laws and Rules, a 50-state review and links to rules. Published by Compounding Compliance service, a private consulting entity. (www.compoundingcompliance.com)

Federal and National Standards for Pharmacies and Pharmacists

For pharmacies and pharmacists who engage in compounding, many states require that all "actions be performed in accordance with United States Pharmacopeia (USP) Standards." The two key standards are termed as follows: USP Standard <Section 795> addresses the practice for Non-Sterile Compounding and USP Standard <Section 797> addresses the practice for Sterile Compounding Preparations. Current state data is noted in the table below.**
The United States Pharmacopeia and The National Formulary (USP–NF) is a book of public pharmacopeial standards. It contains standards for (chemical and biological drug substances, dosage forms, and compounded preparations), excipients, medical devices, and dietary supplements. The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding.

Overview and Examples of State Laws and Actions
The following are a few examples of state actions cited this fall:

• In 2011-2012 at least 16 states enacted laws affecting the practices of compounding pharmacies. A new table, 2011-2012 Compounding Pharmacies-related Enacted Legislation of these measures, Alabama, Colorado, Indiana, Kansas, Kentucky, Michigan, Minnesota, Nebraska, New Jersey, Ohio, Oklahoma, Rhode Island, Utah, Virginia,Washington and West Virginia, is included below
• The Missouri Board of Pharmacy in 2006 began randomly sampling compounded drugs, "after a pharmacist in Kansas City, Mo., pleaded guilty to watering down chemotherapy drugs. In 2008, one in four samples failed a potency test. The failure rate dropped to 15 percent in 2010, the most recent year available."
• The Texas State Board of Pharmacy started its own random testing program after examining what Missouri had put in place. “If you take a drug, you should expect to get the amount of drug listed on the bottle,” said Gay Dodson, the Texas board’s executive director. In April 2012, a compounding pharmacy in Dallas, ApotheCure Inc., and its owner, pleaded guilty in federal court to two misdemeanors for shipping a misbranded drug that led to the deaths of three people in the Pacific Northwest. Subsequent testing by the F.D.A. found that some vials were superpotent, containing 640 percent of the drug listed on the label, while others were subpotent."
• Six states (Arizona, California, Missouri, New York, North Carolina and Rhode Island) had “state enforcement records related to the safety of compounding pharmacy practices" publicly available with state enforcement records according to the survey published by Rep. Edward Markey’s staff. The other 44 states had varying practices.
• The Massachusetts Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department has taken several actions in the wake of discovering that the large-scale compounding pharmacy, New England Compounding Center, now closed, was identified as shipping large quantities of contaminated or non-sterile injectable drugs. Those Massachusetts-originated drugs may have been used by some 14,000 patients in more than 20 states. As of Oct. 28, state officials had moved to order three compounding pharmacies to cease work. Infusion Resource voluntarily surrendered its license on October 27, according to the director of the. The third company, Ameridose, has ceased distribution. State inspectors who visited Infusion Resource found “significant issues with the environment in which medications were being compounded.” Gov. Deval Patrick also directed the state’s Board of Registration in Pharmacy to start unannounced inspections immediately of compounding pharmacies that prepare sterile, injectable medications. There are 25 such pharmacies in Massachusetts; Gov. Patrick has acknowledged that the state rules governing them were insufficient.

Compounding Pharmacies in the News

• Utah moving to fortify regulation of compounding pharmacies; Meningitis outbreak pointed out state-federal weaknesses in oversight. - SLC Tribune, Dec. 6, 2012
• DeLauro, Lowey Introduce Legislation Strengthening Oversight of Compounding Pharmacies, December 5, 2012. "Washington, DC— Representatives Rosa DeLauro (D-CT) and Nita Lowey (D-NY) introduced legislation today to improve the failed regulatory framework currently governing compounding pharmacies and clarify the Food and Drug Administration (FDA)’s ability to oversee such pharmacies. A compounding pharmacy in Massachusetts was responsible for the meningitis outbreak that sickened over 500 people and caused at least 36 deaths."
• According to a New York Times article in October, "There have been virtually no federal efforts to quantify the problem of large-scale compounding pharmacies or their rapid growth, but the F.D.A. has occasionally taken a limited look at the quality of their drugs. In 2001, the agency looked at samples of compounded products from 12 different pharmacies and found that a third of the products failed one or more standard quality tests, mostly having to do with potency. A similar F.D.A. survey in 2006 found the failure rate about the same.
• US concern over compounders predates outbreak of meningitis | Editorial: Deeper Concerns About Drug Compounding - The New York Times
• "Compounding Pharmacies, Compounding Risk" - New report from the office of Congressman Edward Markey (MA), October 2012
• Officials: Murky rules harmed meningitis case - The Washington Post
• Meningitis Exposure Patients Wait and Worry - The New York Times

Existing state regulations as of Dec. 2012

Note that these provisions may not be the only regulations affecting a given pharmaceutical facility--other licensing and inspection provisions may also apply. The National Association of Boards of Pharmacy (NABP) is the nationwide authority that records and facilitates the work of the individual state Boards of Pharmacy, established by law in virtually every state and territory. NCSL consulted the NABP "Minimum Standards of Practice" survey in the compilation of this state law and regulation table. To view or order NABP legal products, visit NABPLaw Online.
KEY: "Sterile Preparations, USP" refers to existing state regulations of in-state compounding pharmacies, requiring that all "actions be performed in accordance with United States Pharmacopeia (USP) Standards."
"PCAB Accreditation" indicates the number of in-state compounding pharmacies that are listed as approved by the "Pharmacy Compounding Accreditation Board,"a voluntary quality accreditation designation for the compounding industry." Nationwide 163 facilities have this accreditation. This list provides the names and locations of accredited pharmacies.

Index by state: A-C | D-H | I-L | M | N | O-R | S-U | V-W   or click here to view state summary