IACP Provides Members with Legal Information on Which States Allow Office Use-No answer from Georgia, Illinois, and New Jersey. Also No Answer as to whether allowed in Puerto Rico, Guam and America Samoa

IACP Introduces the First Installment of its New Member Resource – the IACP Law Library

As part of our ongoing development of tools, programs and materials that help our members improve their professional and business practice, IACP is launching its IACP Law Library. As conceived, this law library will provide pharmacists with a comprehensive analysis of state pharmacy law and regulation that affect many day-to-day decisions.
Our first installment in the new IACP Law Library—Compounding for Office-Use is now available for purchase! Click here for purchase information.
Working in collaboration with the National Alliance of State Pharmacy Associations (NASPA), IACP created this resource after a lengthy and detailed review of the pharmacy statutes and regulations of the 50 states as they pertain to the sales of prescription drugs for office use to practitioners by pharmacies and compiled. That included checking wholesaler licensure laws and regulations (state PDMA laws), controlled substance regulations when referenced by the Boards of Pharmacy, as well as individual states’ labeling statutes and regulations. Once that was completed, the Boards of Pharmacy were contacted to confirm and obtain information, especially, for those states whose laws and regulations were not clear as to whether sales for office use is allowed and what the requirements are. Follow-up phone calls and emails were made to nearly 40 states. Only three states did not respond to our request for a formal review (Georgia, Illinois, and New Jersey). As an added check, several state pharmacy associations also reviewed the final chart.
Overview of Results
The majority of the states (42) allows pharmacies to sell any non-controlled prescription drug and compounded drugs to practitioners for office use. Six states specifically prohibit that activity, and two states appear to be silent. Silent means the statutes and regulations do not specifically say whether it’s allowed. As our phone calls to the states Boards revealed, silent does not necessarily mean it is not allowed. Many of the states Boards confirmed that although the statutes or regulations don't say office use is specifically permitted, the Boards allow by broad interpretation, board policy, or by common practice covered by a pharmacy’s license the provision of office-use prescriptions.
For the most part, those states that do specifically prohibit office-use prescriptions provide for a “sales” process instead and require that in lieu of a prescription, orders from practitioners must be placed via an invoice. Several of these states limit the amount of product that a pharmacy can sell to a practitioner for office use to either 5% of the total annual sales or 5% of the total dosages in a consecutive 12-month period. This five percent figure appears in many of the states controlled substances laws and is being applied by the Boards to sales for office use in general.
The percentage limitation is from the federal DEA Controlled Substances Act and rules. The five percent language was placed into some of the states PDMA laws – which deal with wholesaler licensure -- where the allowing of sales for office use also is found in an exemption provided in the definition of wholesale drug distribution. In these states, sales to practitioners are not wholesale drug distribution and do not require a wholesaler license. Many of the states providing the exemption limit the sales to 5%. If sales exceed 5%, then a pharmacy would be required to obtain a wholesale drug distributor license.
Unanswered Questions
Even the best research has limitations. Three states did not respond to our numerous phone calls and emails for clarifications and additional information. They are: Georgia, Illinois, and New Jersey.

• Based on our review of the statutes and regulations, Georgia allows the sale to practitioners for legend drugs but is not clear as to whether such is allowed for compounded products.
• Illinois and New Jersey allow the sale of compounded products for office use but appear to be silent as to whether legend drugs may be sold to a practitioner for office use.

IACP members doing business in those states should confer with the Board of Pharmacy if they have any questions.
Toward the end of our research, we were asked to determine whether Puerto Rico, Guam, and America Samoa allowed sales for office use. Phone calls have been made and emails sent; however, we have not received any response. Once received and confirmed, IACP will update our Law Library.
Quoted from and More information found here

Reminder the National Conference of State Legislators (NCSL) Has great Resources including links to all the current state compounding laws and the proposed legislation

found here

NCSL Meeting Session - Fall Forum, Dec. 6, 2013
Tracking Tracing and Compounding: An Update on Pharmaceutical Legislation

• Jane Axelrad, Food and Drug Administration (FDA) - View slides: Presentation 
• I. Bernstein, Food and Drug Administration (FDA)- View slides: Presentation 
• Elizabeth "Scotti" Russell, Government Affairs Manager, National Association of Boards of Pharmacy (NABP), Illinois - View slides: Presentation 

A Prescription that Works for Pharmacy Risks--Compounding Pharmacy Insurance

A Prescription that Works for Pharmacy Risks
by Dan Springman

Once upon a time insurers would jump at the chance to provide a neighborhood pharmacy with a Business Owners Policy that included professional liability coverage by endorsement. But as the extent of this sector’s professional liability exposures has become apparent, many carriers have come to view the class as unattractive. Beazley’s approach is different. Working closely with pharmacies and their brokers to identify pharmacies’ exposures and ensure that appropriate risk management procedures are in place, we continue to provide competitive coverage while minimizing claims.


All pharmacies, from the largest national chains down to Main Street mom-and-pop shops, have substantial professional liability risks. Opportunities for human error are abundant. Since many medicines look alike, a prescription container may be mislabeled, or the wrong capsules may be grabbed off a shelf. Improperly securing medicine (not using child-proof caps, for example) can put a pharmacist at risk. It can be as simple as a cashier accidentally handing over the wrong bottle to a customer. Or as monumental as a pharmacist erring in transcribing a prescription for 21 polo horses, resulting in a fatal overdose of the animals.

Compounding the exposure Compounding drugs involves combining, mixing, or reconstituting existing pharmaceuticals to meet the unique needs of a patient. It may mean suspending and flavoring an antibiotic to make it child-friendly, or altering the dosage of medication capsules to accommodate a doctor’s prescription. Compounding elevates exposures. Consider the recent, high-profile case of a meningitis outbreak sparked by a widely-given steroidal injection that was contaminated during the compounding process.

While specific pharmaceuticals are regulated by the US Food and Drug Administration, compounded drugs are not. Change is in the wind, with Congressional passage late last year of the Drug Quality and Security Act, which opens the door for the FDA to develop voluntary regulations on compounding and traceability of prescription drugs.

Smaller pharmacies are especially vulnerable to many professional liability claims since they are less likely than their larger counterparts to have extensive procedural checks
continue to read here