6 Surprising Pharmacy Laws

JULY 01, 2015
Are you familiar with the following pharmacy laws?

1. No chain pharmacies allowed

Although chain pharmacies account for roughly 70% of the pharmacy market, one state has effectively prohibited them from opening.
 
A 1963 North Dakota law states that only a licensed pharmacist or group of pharmacists can own and operate a pharmacy within the state.
 
A referendum called the North Dakota Pharmacy Ownership Initiative, Measure 7 was drafted in November 2014. Funded by Walmart, the measure sought to repeal the 1963 law, promoting decreasing drug costs through competition for prescription drug sales. The measure was defeated, with 59% of residents voting “No” to its implementation.
 
2. Generic substitution

The legal responsibility for generic substitution can vary based upon the state where the prescriber is practicing and the type of medication prescribed.
 
Thirty-one states currently require the use of the FDA's Orange Book, a guide for therapeutic equivalency, to determine generic substitution. Fifteen states, including Florida, Massachusetts, and Utah, provide a drug formulary that determines which drugs are deemed equivalent and interchangeable. Five states, including Arkansas, Kentucky, and Missouri, provide a list of drugs that are not equivalent and therefore not interchangeable.
 
Several states have enacted unique interchange laws regarding narrow therapeutic index (NTI) drugs. Hawaii, for example, requires both practitioner and patient consent for pharmacists to substitute an equivalent generic product for any antiepileptic drug. The boards of pharmacy in Kentucky, North Carolina, and Pennsylvania all maintain a list of NTI drugs that are not to be substituted.
 
Oklahoma law has taken an even stricter stance, stating that “at no time will a pharmacist substitute or cause to be substituted any drug, medicine, chemical, or pharmaceutical preparation without the authority of the prescriber or purchaser.” 
 
3. Non-controlled prescription expiration

Federal law places no specified time limit to fill non-controlled substances, resulting in many states adopting their own limitations.

Thirty-six states currently mandate that a non-controlled prescription cannot be filled after 1 year from the date it was issued. Idaho and Maine have extended this interval to 15 months, and Iowa to 18 months. Wyoming currently has the longest defined limitation at 2 years.

Most surprisingly, 8 states, including Alabama, California, Massachusetts, and New York, have no defined expiration limit. At the pharmacist and insurance company’s discretion, a non-controlled prescription can be legally dispensed in these states many years after they are written.

4. Prescriptive authority

Those working in a retail pharmacy cannot second guess whether a prescription is written by a practitioner with prescriptive authority. However, it can vary widely by state and practitioner type.

Clinical nurse specialists, for example, have some degree of prescriptive authority in 26 states, including Colorado, Illinois, and Texas. Homeopathic physicians can be licensed in 17 states with varying degrees of prescriptive authority. Licensed clinical psychologists with specialized training can prescribe certain medications for the treatment of mental health disorders in Illinois, New Mexico, and Louisiana.

In Florida, nurse practitioners and physician assistants are prohibited from prescribing any controlled substance. Optometrists cannot prescribe controlled substances in 5 states.

5. Technician-to-pharmacist ratios

Pharmacy technicians play an integral role in the retail and institutional pharmacy settings. The number of pharmacy technicians permitted to work under pharmacist supervision varies by state.
 
About half of states mandate that ratios not exceed 2 or 3 technicians per pharmacist. Idaho and Indiana currently have the highest ratio, at 6:1.
 
Eighteen states, including Arizona, Kentucky, Michigan, Ohio, and Vermont, have no maximum limit on the number of the technicians that can work under a pharmacist at 1 time.
 
6. No Rx means no pseudoephedrine

In 2005, the Combat Methamphetamine Epidemic Act (CMEA) was established to regulate OTC pseudoephedrine (PSE) sales due to the illicit use. CMEA established daily and 30-day purchase limits, product placement in the pharmacy, logbooks, and ID verification.

Two states have since taken an even stricter stance. Oregon and Mississippi both classify PSE as a Schedule III substance, requiring a prescription to dispense it.
 
In the 2013 legislative session, at least 16 bills were introduced in 8 states that would mandate prescriptions for PSE products, according to a recent report from the US Centers for Disease Control and Prevention.

References:
  1. “2015 Survey of Pharmacy Law”. National Association of Boards of Pharmacy. Web June 28 2015.
  2. “About Prescribing Psychologists”. APA Practice Central. Web. 1 July 2015.
  3. Hensen M. “North Dakota Has a Unique Law Protecting Locally Owned Pharmacies—But This Ballot Measure Could Wipe It Out.” YES! Magazine. Oct 31, 2014.
  4. “Licensed States & Licensing Authorities.” American Association of Naturopathic Physicians. Web 30 June 2015.
  5. “Mid-Level Practitioners Authorization by State.” Drug Enforcement Administration. Web. 1 July 2015.
  6. “Pseudoephedrine: Legal Efforts To Make It a Prescription-Only Drug.” Centers for Disease Control and Prevention. Web 1 July 2015.
  7. Vivian C. Generic-Substitution Laws. US Pharm. 2008;33(6)(Generic Drug Review):30-34.


Timothy O'Shea, PharmD
Timothy O'Shea, PharmD
Timothy O'Shea, PharmD, is a Clinical Pharmacist working at a large health insurance plan on the east coast. Additionally he works per diem at a retail pharmacy chain. He graduated from MCPHS University - Boston in 2015 and subsequently completed a PGY-1 Managed Care Pharmacy Residency. His professional interests include pharmacy legislation and managed care pharmacy. He can be followed on Twitter at @toshea125.
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