Pharmacy Resource Center
The opportunity to accept an appointment as the Pharmacist-in-Charge (PIC) of a pharmacy permit requires the pharmacist to first obtain a PIC privilege. The PIC privilege is a virtual credential (meaning no paper copy is available but it is verifiable on the Board's website) with no fee. Once issued, it is valid as long as the underlying pharmacist license is valid unless restricted by the Board; the PIC privilege requires no renewal. The PIC privilege is obtained by submitting a properly completed Form No. 62 - Affidavit of Acknowledgment and Acceptance of Responsibility by Pharmacist-in-Charge to the Board office. Since the form requires notarization, the original notarized document is required; we cannot accept scanned or faxed copies of this document. The minimum requirement for a PIC privilege is two years of licensed practice as a pharmacist and an active Louisiana pharmacist license. The responsibilities for the PIC are specified in the Louisiana Pharmacy Law Book (§1105 for in-state pharmacies and §2307 for nonresident pharmacies); we strongly encourage your review of that information before seeking the PIC privilege.
In the event a change is contemplated in the PIC position in a pharmacy, there are three written notices required to the Board office:
> The departing PIC shall give written notice to the Board and the owner of the phamacy permit of his intent to relinquish the PIC appointment no less than 10 days prior to the anticipated date of departure. This preliminary communication may be sent to the Board office by email, fax, or mail. We recommend the departing PIC keep a personal record of his timely notice to the Board and the owner of the permit.
> The owner of the pharmacy permit shall notify the Board of a change in the PIC within 10 days after such change is made. Completion of Form No. 61 - Notice of Change of Pharmacist-in-Charge and timely receipt of a copy of that form in the Board office satisfies this notice requirement. The original copy of this completed form is a pharmacy record and should be maintained in its records. A copy of the form may be emailed, faxed, or mailed to the Board office. We recommend the pharmacy keep record of its timely submission of the form to the Board office.
> The incoming PIC shall give written notice to the Board of his acceptance of the PIC appointment within 10 days after beginning that appointment. Completion of the PIC change notice and its timely receipt in the Board office satisfies this notice requirement
With respect to changes in the PIC position, the final duty of a departing PIC and the first duty of an incoming PIC are the same: a complete inventory of all controlled substances under the pharmacy's control. In the event such drugs are held in multiple locations, then the inventory shall include all locations. In the ideal scenario, the departing and incoming PICs are present at the same time to conduct the inventory and sign the inventory record. In the event the replacement PIC is not available when the departing PIC conducts the inventory, the departing PIC shall conduct the inventory and sign the inventory record, then complete his portion of the PIC change notice form and send a copy of the form to the Board office. When the Board receives that form, it then relieves the departing PIC of responsibility for the permit. The departing PIC retains responsibility for a pharmacy permit until the Board receives proper notice of a PIC change. In the event the departure of a PIC is involuntary, the departing PIC is not responsible for compliance with the 10-day advance notice requirement, but he is responsible for the final inventory of controlled substances. The owner of the phamacy permit shall not interfere with the departing PIC's obligation to conduct the final inventory of controlled substances.
The Louisiana Board of Pharmacy collaborated with the National Association of Boards of Pharmacy (NABP) and other state boards of pharmacy to develop uniform inspection criteria for pharmacy services. These inspection blueprints identify the questions and data collection points to be reviewed by compliance officers during inspections.
Module 1 ~ Basic Pharmacy Services
Module 2 ~ Compounding of Nonsterile Preparations [per Board rules, requires compliance with USP <795> standards]
Module 3 ~ Compounding of Sterile Preparations [per Board rules, requires compliance with USP <797> standards]
With respect to the inspection of pharmacies for compounding of sterile preparations, the Board requires its inspectors to obtain and maintain the NABP/CriticalPoint Certification in Sterile Compounding for Inspectors (CISCI). As an alternative to securing inspections by Louisiana Board compliance officers, the Louisiana Board accepts inspections performed by similarly qualified surveyors employed by NABP as well as the Accreditation Commission for Health Care (ACHC) using the same inspection blueprint (Module 3). Other inspection forms may be accepted as long as they provide a similar or superior level of documentation of compliance with the USP standards as determined by the Board's Compliance Division.
The Board requires a pharmacy to have a recent inspection in order to renew its permit for the next calendar year. A recent inspection is one that was performed within the two-year period preceding the date of the renewal application form
The ability of a pharmacy in Louisiana to procure, possess, dispense, and distribute controlled substances requires three credentials: (1) a current Louisiana pharmacy permit, (2) a current Louisiana Controlled Dangerous Substance (CDS) license, and (3) a current federal Drug Enforcement Administration (DEA) registration. Pharmacies may obtain the first two of these credentials from the Board of Pharmacy and the latter from the DEA. Pharmacies in Louisiana in possession of controlled substances are required to adhere to the federal rules for controlled substances, found in 21 CFR 1300 to end, as well as the state rules for controlled substances, found in Chapter 27 - Controlled Dangerous Substances in the Board's Louisiana Pharmacy Law Book.
Pharmacists should be aware the DEA and the State of Louisana both publish lists of controlled substances, composed of Schedules I, II, III, IV, and V. For the most part, the schedules are the same. However, there is always the potential for differences. In the event there are differences in the scheduling (or the absence of a listing), then the pharmacist is always obliged to adhere to the more stringent provision. At the time of this writing, there were two differences between the federal and state list: (1) carisoprol is listed in Schedule II in Louisiana and Schedule IV on the federal list, and (2) ephedrine, pseudoephedrine, and phenylpropanolamine are listed in Schedule V in Louisiana and are not listed on the federal list. The state list of controlled substances is maintained by the state legislature; it is organized by schedule, pharmacologic category, and generic name.
The DEA's Pharmacist's Manual contains guidance information on how to comply with the federal rules governing controlled substances. The Board has also included additional information within its Louisiana Pharmacy Law Book, including information on prescribers with authority for controlled substances as well as a summary of the Board's inventory requirements (which are more stringent than the federal requirements).
The DEA's rules for the reporting of thefts and losses of controlled substances are found in 21 CFR 1301.76(b), which is replicated here for your covenience: "The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft."
The Board's rules for the reporting of thefts and losses of controlled substances are found in LAC 46:LIII.2737.D, and are essentially the same, differing only in the submission of the same information to the Board at the same time as the DEA.
Thus, there are two requirements: (1) initial notification to the DEA and the Board within one business day of the discovery of the theft or losss, and (2) completion of DEA Form 106 and submission of that report to the DEA and the Board. With respect to the initial notification to the DEA, the New Orleans Field Division has established an email address to facilitate that report. Please direct your initial report of theft/loss of controlled substances to NOFD.firstname.lastname@example.org and copy email@example.com. That one email, copied to both agencies, will satisfy that obligation. You should be aware that DEA 106 reports may be submitted to the DEA electronically at https://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html. Please print a copy of that report and send it to the Board - by email at firstname.lastname@example.org, by fax at 225.922.0316, or by mail to the Board office in Baton Rouge. The DEA requests that you NOT print and email a copy of the 106 report to their email address.
The Louisiana Legislature adopted the Prescription Monitoring Program (PMP) Law in 2006. That law authorized the Board of Pharmacy to establish and maintain a database of all prescription transactions for all controlled substances and drugs of concern dispensed to Louisiana residents by all Louisiana-licensed pharmacies as well as any practitioners who dispense such prescriptions to their patients. Some transactions are excluded, e.g., controlled substances administered to patients within hospitals, and practitioners dispensing less than a 48-hour supply to their patients. In addition to housing records of controlled substance prescription transactions, the PMP Law authorizes prescribers and dispensers to query that online database when caring for their own patients. The law also permits inquiries by the professional licensing agencies of prescribers and dispensers, Medicaid representatives on behalf of Medicaid recipients, as well as law enforcement agencies for use in active investigations.
To comply with the PMP Law, the Board promulgated Chapter 29 - Prescription Monitoring Program. The Board has also published additional resources for pharmacies and pharmacists on its website, which is available here.
As referenced above, these three drugs are listed in Schedule V in Louisiana. Therefore, the ability to procure and possess any of these drugs requires a Louisiana CDS license. Pharmacists should be aware there are both prescription and nonprescription drug products on the market containing these drugs. With respect to the nonprescription products containing any of these three drugs, there are no other retail outlets in possession of a Louisiana CDS license, therefore these nonprescription products are only available in pharmacies in possession of a Louisiana CDS license.
To comply with the PMP Law, pharmacies are required to report their prescription transactions involving any of these three drugs to the PMP database. Nonprescription transactions are also reportable - not to the PMP but to another program.
The 2009 Louisiana Legislature adopted the Ephedrine, Pseudoephedrine, & Phenylpropanolamine Act to combat the methamphetamine abuse prevalent at that time. This law authorized the Louisiana State Police (LSP) to establish a database consisting of all retail transactions for nonprescription products containing any of these three drugs. The law also established a minimum age to sell or purchase any nonprescription product containing any of these three drugs, and further, established a maximum amount of such drugs that can be purchased within a certain period of time. In particular, the purchaser must present a photo identification card issued by a state or federal government and must sign a written or electronic log at the time of the sale. The pharmacy shall not sell more than 9 grams of the base drug to the same purchaser within any 30-day period of time.
Pharmacies selling any nonprescription producs containing any of these three drugs shall register with the National Precursor Log Exchange (NPLEx) and report these transactions in real-time to that database. Pharmacies owned by chain organizations are automatically enrolled by their corporate offices. Independent pharmacies shall begin the registration process by completing the online survey found at www.NPLExSurvey.com.
The Board's Rule 519 ~ State of Emergency is automatically activated whenever the Governor issues a proclamation declaring a state of emergency for a portion, or all, of the state. The rule permits a pharmacist in the area of the state under the declaration of emergency, using sound professional judgment, to dispense an emergency prescription of up to a one month supply of any medication. It is important to remember the rule is activated automatically on the declaration by the Governor and requires no further notice from the Board.
Pharmacies seeking additional resource information may find these publications useful: Emergency Preparedness Information from the National Council of Prescription Drug Programs (NCPDP) and Guidelines for Responding to Disasters from the International Pharmacy Federation (FIP).
A pharmacy permit is valid only for the owner to whom it was issued and only for the location recorded on the permit. It is not transferable to a new owner or to a new location. In the event a relocation is planned, the permit owner shall complete the appropriate application form (Form No. 54 for in-state pharmacies and Form. No. 59 for nonresident pharmacies) and submit it to the Board at least 30 days prior to the planned move. After completing the required site inspection for the in-state pharmacy, the Board will re-issue the permit, using the same permit number and the new address.
In the event the owner of a pharmacy permit contemplates a sale or transfer of ownership of a pharmacy, the owner should recognize the pharmacy permit is not transferable to a new owner. The owner can sell everything else in the pharmacy (drug products and fixtures) but not the pharmacy permit. The buyer of the pharmacy must obtain his own permit via the application process. From time to time, the ownership profile of the pharmacy may undergo minor changes; however, in the event the ownership of the pharmacy permit changes by 50% or more since the initial issuance of the permit, the Board's rules declares that level of change to be self-evident of a change sufficient to require a new pharmacy permit. The continued operation of a pharmacy permit which has changed its ownership by 50% or more is a violation of the Board's laws and rules; regrettably, the Board has found it necessary to discipline several permits for that reason. From time to time, a permit owner may elect to change their trade (d/b/a) name. A change in the trade name only, with no change in ownership, does not require a new permit nor an application, but it does require written notice to the Board. Further, in the event an updated copy of the permit reflecting the new trade name is desired, please use the duplicate credential order form (Form No. 201).
In the event the owner of a pharmacy contemplates the permanent closure of a pharmacy, there are specific rules of procedure designed to protect consumers' rights of access to their prescription records. In addition, we strongly encourage completion of Form No. 60 to ensure documentation of the pharmacy's compliance with those rules.
This link will take you to a page in the Public Libary on this website which contains the Louisiana Pharmacy Law Book as well as any Emergency Rules that may be in effect.
This link will take you to a page in the Public Library on this website which contains Declaratory Statements, Advisory Opinions, and Policy Statements issued by the Board.
This link will take you to a page on this website which contains all the forms that might be needed by a pharmacy, including:
Applications for New Permit, Relocation of Permit, and Notice of Permanent Closure
Applications for New AMS registration and EDK permit
Application for New CDS license for in-state pharmacy
Notice of Change of Pharmacist-in-Charge
CDS Inventory Certificate
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