News Louisiana Board Of Pharmacy

National Pharmacy Compliance Newsantibodies (eg, adalimumab), and vaccines (eg, influenza andtetanus).Section 351(k) of the Public Health Service Act (PHS Act)provides an abbreviated licensure pathway for biologicalproducts shown to be biosimilar to or interchangeable with anFDA-licensed reference product, which can help provide moreaffordable treatment options for patients. For example, on March23, 2020, FDA-approved insulin products were transitioned toregulation as biological products under the PHS Act, whichmeans that transitioned insulin products are open to competitionfrom future biosimilars, including interchangeable biosimilars.Key Terms for Biosimilar and InterchangeableProducts Biosimilar Product: A biosimilar is a biological productthat is highly similar to and has no clinically meaningfuldifferences from an FDA-approved reference product. Interchangeable Product: An interchangeable product isa biosimilar that meets additional approval requirementsand may be substituted for the reference product withoutthe intervention of the prescribing health care provider. Reference Product: A reference product is the singlebiological product, already approved by FDA, againstwhich a proposed biosimilar or interchangeable productis compared.Are Biosimilars the Same as Generic Drugs?Biosimilars and generic drugs are versions of brand namedrugs and may offer more affordable treatment options topatients. Biosimilars and generics are approved through differentabbreviated pathways that avoid duplicating costly clinicaltrials. But biosimilars are not generics, and there are importantdifferences between them.For example, the manufacturer of a generic drug mustdemonstrate, among other things, that the generic contains thesame active ingredient as the brand name drug and that thegeneric is bioequivalent to the brand name drug. By contrast,biosimilar manufacturers must demonstrate that the biosimilaris highly similar to the reference product, except for minordifferences in clinically inactive components, and that thereare no clinically meaningful differences between the biosimilarand the reference product in terms of safety and effectiveness.Unlike generics, biosimilars are generally prescribed bybrand name by a health care provider, while interchangeables,like generics, may be substituted without the involvement ofthe prescribing health care provider, depending on state laws.What is the Purple Book?The Purple Book database contains information on FDAlicensed (approved) biological products regulated by the Centerfor Drug Evaluation and Research, including licensed biosimilarand interchangeable products, and their reference products. Italso contains information about all FDA-licensed allergenic,cellular, and gene therapy, hematologic, and vaccine productsregulated by the Center for Biologics Evaluation and Research .The Purple Book has simple and advanced search capabilitiesand some information that you can find includes the proprietary(brand) name and nonproprietary (proper) name of biologicalproducts, applicant (company), dosage form, product presentationJanuary 2021(eg, autoinjector, vial), route of administration, and strength. ThePurple Book also will display FDA-approved interchangeableproducts and note with which brand product each interchangeableproduct may be substituted.Are Therapeutic Equivalence Codes Assigned toBiological Products?FDA does not assign therapeutic equivalence codes tobiological products listed in the Purple Book like it doesfor small molecule drugs listed in the “Orange Book.” ThePurple Book provides information about whether a biologicalproduct has been determined by FDA to be biosimilar to orinterchangeable with a reference product.Can Interchangeable Products Be Substituted atthe Pharmacy?Many states have laws that address pharmacy-level substitution, including permitting substitution of interchangeableproducts, and the specific laws vary from state to state.There are currently no FDA-approved interchangeableproducts. Once there are, interchangeables, by definition, canbe expected to produce the same clinical result as the referenceproduct in any given patient.Biosimilar and interchangeable products meet FDA’s rigorousstandards for approval, and patients and health care providerscan be assured of the safety and effectiveness of these products,just as they would for the reference product.Where Can I Find Additional Resources? fda.gov/biosimilars purplebooksearch.fda.gov mation/deemed-be-license-provision-bpci-act fda.gov/media/135340/downloadFinal Insanitary Conditions at CompoundingFacilities Guidance Released by FDAContinuing efforts to protect patients from exposure to poorquality compounded drugs, FDA has published final guidancefor compounding facilities regarding insanitary conditions. Thefinal guidance, Insanitary Conditions at Compounding FacilitiesGuidance for Industry, provides recent examples of insanitaryconditions that FDA has observed at compounding facilitiesand details corrective actions that facilities should take whenthey identify these conditions. The guidance is intended to helpcompounders identify and prevent such issues at their facilities.While some compounders work hard to meet qualitystandards, FDA says its investigators continue to observe poorconditions that impact drug quality and that have the potentialto harm patients. These include the presence of dirt, mold,insects, trash, peeling paint, unclean exhaust vents, and dirtyhigh-efficiency particulate air filters.In response to the draft guidance, FDA states that it hasalso added recommendations for compounders to use riskmanagement tools to develop appropriate controls to preventinsanitary conditions at facilities. The guidance also addressesthe regulatory actions that FDA may take in response to theseconditions.Page 3

Louisiana Board of Pharmacy NewsJanuary 2021continued from page 1emergency as well as the declaration of emergencyfor Hurricane Laura. The members noted that someof the temporary waivers had already been convertedto permanent rules, some measures were no longernecessary, and some were still necessary. The Boardterminated some policies and extended others. Thestatus of all 26 interim policies may be verified underthe State of Emergency tab on the Board’s website.The Board also distributed this information by emailto all pharmacy licensees in early December. The members recalled an earlier decision in 2019 todelay enforcement of the federal standards on thehandling of hazardous drugs found in United StatesPharmacopeia Chapter 800 until January 1, 2021.They considered that pharmacies attempting tocomply with those standards have most likely beenimpacted by the current public health emergency.The members voted to further delay the enforcementof those standards to an undetermined date in thefuture beyond calendar year 2021. While the Boardhas opted to delay its enforcement, it is possiblepharmacies may have relationships with otherorganizations that have not delayed their expectationof compliance with those standards. The members took note of a temporary conflict inthe CS status of prescription cannabidiol. Whilethe federal government has removed that drug fromSchedule V of the federal list of CS, the LouisianaLegislature will not have the opportunity to makethat same decision until its next regular session laterthis year. In the interim, the Board voted to exerciseenforcement discretion and not take any disciplinary action against a pharmacy dispensing such prescriptions as non-CS. The Statement on DispensingPrescriptions for Cannabidiol resides on the Board’swebsite and was distributed by email to all pharmacylicensees in early December. Although some of the Board’s credentials currentlyexist only in virtual format, the Board voted toexpedite the transition of all of its credentials frompaper format to a virtual format, meaning no paperform will exist. All credentials are verifiable on theBoard’s website. Anyone needing a paper documentcan print the credential verification screen, whichincludes a notation that the Board’s website is a secureand primary source for credential verification, asauthentic as a direct inquiry to the Board. Staff willbegin transitioning credentials to virtual status. Itis possible some new credentials may be issued inpaper format with renewals converting to virtualformat.Disciplinary and Other LicensureActions (21-01-660)During its November 18, 2020 meeting, the Board tookaction on several items of business, including:Tamara Lynn Bourg (CPT.004979): Board grantedher request for reinstatement of the lapsed certificate,contingent upon satisfaction of the followingrequirements prior to November 18, 2022: (1) acquisitionof at least 250 hours of updated practical experienceunder the authority of a special work permit to berequested from the Board office; (2) receipt of a letterof competency from the pharmacist supervising theupdated practical experience; and (3) acquisition of atleast 10 hours of Accreditation Council for PharmacyEducation (ACPE)-accredited technician-specificcontinuing pharmacy education (CPE).Delana Rae Heltz (CPT.009588): Board granted herrequest for reinstatement of the lapsed certificate,contingent upon satisfaction of the followingrequirements prior to November 18, 2022: (1) acquisitionof at least 250 hours of updated practical experienceunder the authority of a special work permit to berequested from the Board office; (2) receipt of a letterof competency from the pharmacist supervising theupdated practical experience; and (3) acquisition of atleast 10 hours of ACPE-accredited technician-specificCPE.Jaime Lynn Blanchard (CPT.001387): Boardgranted her request for reinstatement of the lapsedcertificate, contingent upon satisfaction of thefollowing requirements prior to November 18, 2022:(1) acquisition of at least 250 hours of updatedpractical experience under the authority of a specialwork permit to be requested from the Board office; (2)receipt of a letter of competency from the pharmacistsupervising the updated practical experience; (3)acquisition of at least 10 hours of ACPE-accreditedtechnician-specific CPE; and (4) successful completionof a Board-approved pharmacy technician examination(Pharmacy Technician Certification Exam administeredby Pharmacy Technician Certification Board or, in thealternative, Exam for the Certification of PharmacyTechnicians administered by National HealthcareerAssociation).Louisiana CVS Pharmacy, LLC, dba CVS PharmacyNo. 4068 (Haughton, LA) (PHY.005771): For itsfailure to conduct a completed CS inventory followingthe discovery of a loss or theft of approximately 3,000tablets of alprazolam 1 mg on December 17, 2018, and forits failure to conduct a complete CS inventory followingthe discovery of a loss or theft of approximatel

3388 Brentwood Drive Baton Rouge, LA 70809-1700 www.pharmacy.la.gov January 2021 Published to promote compliance of pharmacy and drug law News Louisiana Board of Pharmacy Board Elects Officers for Calendar Year 2021 (21-01-655) During the November 18, 2020 meeting, the Louisiana Board of Pharmacy members conducted their annual elec -