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