Virginia Board of Pharmacy Legislative and Regulatory Updates

D epar t m ent of H eal t h P r of essi ons Virginia Bo ard of Pha rmacy Law Update Virgi nia So ciety of Health - Sy stem Pharm acists November 7, 2025 Caroli ne D. Juran, R Ph, Ex ecutive Direc tor Beth O’ Halloran, RPh, Deputy Ex ec utive Direct or Ellen Shinaberry, PharmD, Deputy Ex ecutive Dir ector

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov • No financial relationships or conflict s of interest to disclose.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Objectives • Describe recent pharmacy legislative and regulatory activity • Review most cited inspection deficiencies in health - systems • Briefly summ arize current innovative pilot program s and address miscellaneous topics

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Pre- Test Questions • In lieu of completing an AS HP/A CPE - accredited training program, a pharmacy technician trainee may complete a training program recognized by PTC B or N HA as of July 1, 2025.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Pre- Test Questions As of July 1, 2025, hospital pharmacies may distribute compounded drugs within its health system under common ownership wh en the compounded drug products are administered only to patients within the hospital or health system.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Pre- Test Questions A staffing request or concerns form regarding pharmacy working conditions may be accessed on the Board’s websi te.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Board Me mbers Larry Kocot, JD, Chairman Shannon Dowdy, PharmD, V ice Chairm an Michelle Hoffer, JD, Citizen Patricia Richards - Spruill, RPh 2 nd term ends 6/30/26 Kelly Hasty Kale, RPh Tim Robertson, RPh Wendy Nash, PharmD Derek Webb, PharmD Kristopher S. Ratliff, DPh Ling Yuan, PharmD 2 nd term ends 6/30/26 1 st t erm ends 6/30/26

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov 2025 Legislat ion

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Pharm acy Technician Ed ucation al Stand ards • HB2307 • Amended § 54.1 - 3321 (B ) to allow compl etion of a traini ng program rec ognized by t he Pharmacy T echnician Certi fication Boar d or National Healthcar eer Associat ion in addition to ex isting educational opti ons

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Collab orative Practice Agr eements • HB1582 • Amended § 54.1 - 3300.1 to specify that a CPA may include pr escribi ng, modificati on, continuation, or disconti nuation of Schedule II - V drugs after proof of such signed agreement i s submitt ed to and authorized by the Board of Phar macy. • Facili tates pharm acists in obtaini ng D EA mi d - level practit ioner regis tration

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Process fo r Ph armacists to O btain D EA Registrati on • Pharmaci sts should send signed col laborativ e practice agreement i nvolving a Schedule II - V drug to board office for review • Board wil l li st pharmacis t’s name and l icense number on website to inform DEA of eligibil ity t o obtai n a mid - level pr actitioner r egistrati on • Submit application t o DEA • DEA w ill onl y issue for applicable drug schedule and only for presc ribing pur poses, not for stock ing.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Process fo r Ph armacists to O btain D EA Registrati on • Must inform the Boar d and DEA if collaborative practic e agreement is res cinded. • Board may peri odically audit to ensure CPA is stil l in effect. • Unless r equired by 18VAC 110 - 40 - 30, CPAs for Schedule VI drugs only do not need to be submi tted to the Board.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov P ro cess fo r P h arm aci sts to O b tai n D E A R eg i str ati o n • M us t i nf or m t he B oar d and D E A i f c ol l abor at i v e pr ac t i c e agr eem ent i s r es c i nded. • B oar d m ay per i odi c al l y audi t t o ens ur e C P A i s s t i l l i n e ffe c t. • U nl es s r equi r ed by 18V A C 110 - 40 - 3 0, C PAs fo r

D epar t m ent of H eal t h P r of essi ons w w w. d hp. v i r g i n i a. g ov P ro cess fo r P h arm aci sts to O b tai n D E A R eg i str ati o n

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov EMS Report • SB1318 • Required Board, in collaboration with VD H and Off ice of Emergency Medical Serv ices, to report on progress of Virginia EMS agenci es in meeting new standards for EMS drug box exc hange program. • https:/ /rga.lis.v irginia.gov/P ublished/2025/ RD627

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Hospita l Centr al Compounding • SB1366 and HB1905 • Amends § 54.1 - 3410.2 t o allow for distribution of compounded drug within health systems under common ow nership when the compounded dr ug products ar e administered onl y to patients within the hospital or heal th system. • Recent guidanc e adopted in September 2025

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Advanc ed Medication A ides • HB2468 • Amends § 54.1 - 3408 to allow advanced medicat ion aides t o administer drugs in nursi ng homes, as determi ned permiss ible by the Boar d of Nursi ng. • Board of Pharmacy exem pt regul ations adopted in September

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Therapeuti c Interchange Workgroup • SB745 • Direc ted Board to convene workgr oup of stakeholder s to review and analyze authority of pharmacis ts to initiat e therapeutic inter change, make recomm endations to stream line process and moderniz e authority, parti cularl y in cases of drug shortages. • Meeting held August 12 th • https://rga.lis.virginia.gov/Published/2025/RD662/PDF

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Recently R egulatory Act ivity

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Central Fill, Rem ote Ph armacy Techs • HB 1068 (Del. Hodges) and SB607 (Sen. McDougle) Section 1 bill from 2024 General Assembly Session • Directed Board to promulgate r egulations to: 1. Allow pharm acy to outsource dispensing of Schedule VI drugs to a central fill phar macy (form er pilot); 2. Allow pharm acy technicians to acces s phar macy database from r emote locat ion.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Central Fill Pharmacy • Pharmacy may outsource tasks associated with dispensing drug to central f il l pharm acy, can be delivered back to originating pharmacy for patient pick - up • Central fill pharmac y must: – Have sufficient automation to support practice & limit distraction; – Not accept prescript ions or communications directly from patients or providers; – Dispense only Schedule VI drugs • Emergency regulat ions effective 6/16/2025 to 12/15/2026 • Replacement regulations underway

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Remo te Processin g by Pharmacy Techni cians • Allows Techs and Interns perform ing duties of Tech to remotely acc ess pharmacy database; • Pharmacist on - site at pharmacy must be readily available, must have technology for adequate supervision • Pharmacist m ay supervise up to 6, but only 4 may be on - site in the pharmacy • Technician Trainees may NOT pract ice remotely • Emergency regulations effective 6/ 16/2025 - 12/15/2026 • Replacement regulations underway

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Pharmac y Worki ng Cond iti ons • Emergency regulat ions replaced with perm anent regulations as of 8/ 27/2025 • Guidance Document 110 - 26 currently being addressed

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Pharmac y Worki ng Cond iti ons, cont. • (i) addresses suff icient staffing to prev ent fatigue, distraction, or other conditions that interfere with a pharmacist's ability t o practice with com petence and safety; • (ii) standar ds for uninterrupted r est periods and meal breaks for pharmacy per sonnel;

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Pharmac y Worki ng Cond iti ons, cont. • (iii) standards that ensure adequate time for pharmacists to complete professional dut ies and responsibilities, including DUR, immunization administ ration, patient counseling, and ver ification of prescription accuracy; • (iv) limiting external factor s such as productivity or production quotas to the extent that such factors interfer e with the ability to provide appropriate professional services to the public.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Pharmac y Worki ng Cond iti ons, cont. • Staffing request or concerns form on Board’s websit e • https:/ /www.dhp.virginia.gov/Boards /Pharmacy/Pharmac yHomepageitems/ News/Content - 8305 35 - en.html • To be pr ovided t o immediate s upervisor of PIC or pharmacist on duty; • Must maint ain copy in pharmacy for 3 years f or board inspection

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Pharmac y Worki ng Cond iti ons, cont. Permit holder must: – res pond to report ing staff m ember to acknowledge receipt, – res olve issue timely, – docum ent any correct ive action, st eps taken toward correct ion as of time of inspection, or justificat ion for inaction; doc umentation m ust be maintained on site for board inspection or produced within 48 hours of request, – Comm unicate corr ective action or justificat ion for inaction to PIC or report ing pharmacist on duty.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Increase in Licen sure F ees • DHP is a non - General Fund agency • Challenges: Recent increases in licensee count and complaints/invest igations, state employee salary increases. • Final regulations under Administrative Review • Unlikely to be finalized prior t o Decem ber renewal period

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Increase in Licen sure F ees • Examples of proposed fees: – Pharm acy renewal: $490 (up from $350) – New additional fee for facilities perf orming sterile compounding: $400 – Change of PIC: $125 (up fr om $65) – Init ial pharmacist: $300 (up from $235) – Pharm acist renewal: $175 (up from $125) – Pharm acy Technician initial: $40 (up from $35) – Pharm Tech renewal: $45 (up f rom $35)

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Centrali zed Wareho user Review of Drug s for Hospita l ADDs • Final regulations effective 8/27/25 • Permits pharm acist at centralized warehouse or wholesale distributor to verify Schedule VI drugs for ADD s in hospitals • Innovative pilots closed

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Automate d Dispensing Dev ices in Nurs ing Homes • Amended 18V AC110 - 20 - 555 • Allows emergency or stat - use medications stored in an autom ated dispensing device to be accessed prior to receiving elect ronic authorization from pharm acist • Final regulations in effect.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Drug s fo r Emergen cy M edical S ervices • Emergency regs effective 8/20/ 24 - 2/19/26 • Proposed replacement underw ay • Many EMS agencies and EMS councils have begun procuring their own drugs • Most hospitals have ceased providing emergency drug kits t o EMS agencies.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Regulat ory Town Hall • All regulatory acti vity m ay be accessed at https://tow nhall.virginia.gov/L/Now InProgress.cf m • Sign up to become a publi c user (receive email notifications regarding meetings and regulatory actions): https://tow nhall.virginia.gov/L/Regi ster.cfm

D epar t m ent of H eal t h P r of essi ons w w w. d hp. v i r g i n i a. g ov Curren t Inno vative Pilots - Licens e Lookup

D epar t m ent of H eal t h P r of essi ons w w w. d hp. v i r g i n i a. g ov Curre nt Innova tive Pilots

D epar t m ent of H eal t h P r of essi ons Inno vative Pil ot Prog ram Overview • Authorized in § 54.1 - 3307.2 • Requires an application to t he Board • Innovative Pilot Special Confer ence Committee • Can include new processes or pr ocedures, within t he current s cope of the pr actice of pharm acy, that relate to the form o r format o f prescri ption s, the manner of transmi tting prescriptions or pr escription information, the manner of required recordkeeping, the us e of unlicensed ancillary personnel in t he dispensing process, and the use of new technologies in the dispensing process. • Shall not authorize ex pansion of the scope of pharm acy practice for pharmacists

D epar t m ent of H eal t h P r of essi ons Current Pilot Programs • Six active program s – Long t erm care, Hospital, and Opioid T reatm ent Programs 1. T ech Bar Code Scan • Multiple locations • Allows a Pharmacy technician to perform the f inal check of Schedule VI controlled substances using barcode technology (10% pharmacist check) • Required to maintain records of the medications, the verifying technician and the supervising pharmacist • Quarter ly reporting requirem ents

D epar t m ent of H eal t h P r of essi ons Current Pilot Programs, co nt. 2. Brightv iew’s Remote Pharm acist Verification 3. PROOF Verifi cation of Take - Home Doses in Opioi d Treatment – Multiple locations for each pilot; Waives t he following Regulations: • 18VAC110 - 20 - 110(A) - to permit a pharmacist to serve as a PIC simultaneously at no more than fi ve opioid treatm ent pharmacies • 18VAC110 - 20 - 109 – which limit s access to the prescription department and requires it to be locked & alarmed when pharmacist not physically on duty • 18VAC110 - 20 - 276(A) – which does not allow for central or remot e processing to include the final verification of a com plete prescription pri or to dis pensing said prescription. • 18VAC110 - 20 - 10 – which defines “on duty” as when a pharm acist in physically present on t he premises at the address of the permitt ed pharmacy

D epar t m ent of H eal t h P r of essi ons Current Pilot Programs, co nt. Brightvie w and P ROOF Verification of Take - Home Doses in Opioid Treatment, w aiv ers cont i nued: • 18VAC110 - 20 - 250(A) (4) – which requires the pharmacist t o sign a daily log verifying the accuracy of presc r iptions dispensed • 18VAC110 - 20 - 270(B) – which requires a pharmacist to verify the accuracy of all prescriptions af ter they have been filled and prior to the delivery • Virginia Code § 54.1 - 3432 which requires that each pharmacy be under the personal supervision of a pharmacist on the prem ises of the pharmacy

D epar t m ent of H eal t h P r of essi ons 4. CVS Heal th Air Support • Waives 18VAC110 - 20 - 276 of the Regulati ons to allow pharmacists to perform final prescription verificati on using a virtual ver if ication process from a remote location • Requires quarterly reporting • Approved for 117 locations 5. Emergency Depart ment Starter Pack Dispensing • Limit ed number of Schedule VI Controlled Substances • All starter packs are ver if ied and prepackaged by a pharmacist in a tamper resistant contai ner and then dispensed from an ADD • Allowed only when outpatient pharmacy services are not readily available Curre nt Pilot Programs, cont.

D epar t m ent of H eal t h P r of essi ons Current Pilot Programs, co nt. Emergency Department Starter Pack Dispensing, cont. – Waives the foll owing requirements: • 18VAC110 - 20 - 470(3) – to allow dispens ing by NP, PA, RN or LPN • 18VAC110 - 20 - 490(D)(2) – to allow dispensing from an ADD by the above practiti oners of the healing arts • 18VAC110 - 20 - 270(B) – to allow the above practit ioners of the healing arts to apply a patient - speci fic label over the pharmacist - ver ified repackaging pharm acy label • Virginia Code § 54.1 - 2914(A), § 54. 1 - 3301(6), and § 54.1 - 3320(A)(6) – pertaining to pharmacist verification and dispensing by a practitioner of the healing arts.

D epar t m ent of H eal t h P r of essi ons Current Pilot Programs, co nt. 6. Use of Technology Assisted Workflow Sy stem for Remote Validation of Sterile Compounding • Addresses difficulty hiring and retaining experienced oncology staff in a remote area where there is only one hospit al • Emphasis on mai ntaining patient safety • Provides for technology - enabled f inal validation of sterile compounding to be performed remotely using within a health system by an oncology pharmacist • Waives Virginia Code § 54.1 - 3410. 2(D) and 18VAC110 - 20 - 276(A) of the Regulati ons – t o allow a s pecially quali fied pharmacist to use technology assisted workflow to r eview and validate oncology - related steril e compounded products f rom a location out side of the hospital – Note: the above are not waived for batch com pounding

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Most Cited Deficiencies for Health System Phar macies

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov • Deficiency 32 – Have a clean room but not all physical standards in place (§ 54.1 - 3410.2) – HEPA f ilters not posit ioned corr ectly resulting in w ide gaps – Air ret urn in ceiling, not low on w all, with no smoke study or smoke study does not demonst rate appropriate airflow. – Cracks obs erved in junc tures of walls – Tape indicat ing line of demarcation torn, ripped, w ith dirt and vis ible hair – Visible crack in t he ceiling around light fixtures – Messy r epairs to drywall leading to shedding, cr acks or crevic es. – Ceiling tiles not sealed in place – PECs with discoloration or subst ances indicati ng not cleaning all surfac es or using incorr ect cleaning product.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov • Deficiency 26 – No documentati on of initi al and at least every 6 months m edia - fill and/ or gloved fingert ip testing for per sons perf orming Category 1 and Category 2 CSPs (§ 54.1 - 3410.2) – Board was using enforcement discretion through October 31, 2024 – Personnel have to the last day of the mont h from the previous date of test ing. Exampl e – test performed January 10, 2025, have until July 31, 2025 to re - test. – The date is the date of t he test, not the date t he results came back.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov • Deficiency 130 – Required compounding/ dispensing/ distr ibution records not complete and properly mai ntained (§ 54.1 - 3410. 2) – Compounding records do not include s t orage requirements. – Compounding records do not include bey ond use date. • Deficiency 132 - Personnel preparing compounded steril e preparations, or have oversight but do not compound, do not comply w ith cleansing and garbing requir ements (§ 54. 1 - 3410.2) – Hair or jewelry not completely covered. – Reuse of garb w hen not permit ted.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov • Deficiency 127 – Repackaging records and label ing not kept as required or in compli ance. (18VAC110 - 20 - 355) – Automati on recently remov ed and bi n filling rec ords for last 12 months were not retrievable. – Pharmacy repackaging drugs that are specifically required to be dispensed in the origi nal container. • Deficiency 147 - Particle counts, environmental sampling, and smoke patt ern testing not performed under dynamic conditions. – May have been done under dynamic conditions but the certification report does not indicate this.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov • Other item s – Def iciency 26b - No documentat ion of initial and at least ev ery 12 months media - fill test ing or gloved f ingertip t esting for persons who have direct ov ersight of c ompounding personnel, but do not compound. Relati v ely new deficien cy (sin ce No v 2023). – A s of 8/ 28/2025, new Deficiency 150 - Cleaning and disinfection activit ies and/or application of sporicidal disinf ectants on surf aces in classif ied areas and/ or SCA do not c om ply with requirements in USP <797>. – Def iciency 149 – Surf ace sample test ing not being per formed - starting to see an up tick in th is defici ency due to more f requent requi rements for surface sampl ing. – Def iciency 24 – amended June 2024 – c ited for ster ile compounding of hazardous drugs in a non - c ompliant c lean room. In the pas t this deficiency stated: “in an area not physicall y separat ed from other preparation ar eas”.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov DSCSA Enfo rcement • FDA c om pliance deadline for most pharm acies was November 27, 2024. • Small dispenser exemption extension unti l November 27, 2026, for pharmacies with 25 or fewer full - time employees who are pharmacists or qualifi ed technicians. Delays implementing certain elec tronic and interoperable DSCSA requirements, suc h as electronic exchange of transac tion information and package - level product verification. • 54.1 - 3434 states "Every pharmacy shall comply with federal requirements for an electronic, interoperable system to identify, trace, and verify presc ription drugs as they are distributed."

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov DSCSA Enfo rcement • If inspector suspects illegitimate product, will use NABP's PULSE to scan and perform verification of product. • Will review invoices for receipt of drug to ensure drugs are being received from lic ensed wholesale distributors or third - party logistics providers. • May be addressed through routine inspection or complaint driven. • Small dispensers could be targeted more during next year. • Must only purchase drug from entities licensed in V irginia to distribute drug.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Guidance Document 110 - 20 • Guidance regarding Eligi bili ty of Dispensing Therapeutically Equivalent Drugs • A manufacturer of a drug is presumed to ha ve established adequate provis ions for pharmacies to return outdated drugs, through the dist ributor or other wise, in accordanc e wit h § 54.1-3408.03 if the drug product is available for or der by pharmacies. Relevant statutes and regulations: Va. Cod e § 54.1-3408.03 • Non - compliance likely will be addressed via complaints • https://www.dhp.virginia.gov/PractitionerResources/Enf orcem ent/

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Other Miscellan eous Topics • Artif icial Intelligenc e • Multi - stat e Licensure • UMPJE • Direct t o Consumer Dispensing

Department of Heal th Prof essions Upcoming Re newal • Annual renewal of pharmaci st licenses and pharmacy technician registrations • Don’t forget to complete required CE ww w.dhp.virginia.gov

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Post - Test Questions • In lieu of completing an AS HP/A CPE - accredited training program, a pharmacy technician trainee may complete a training program recognized by PTC B or N HA as of July 1, 2025. Tr u e.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Post - Test Questions As of Jul y 1, 2025, hospital pharmacies may distribute compounded drugs within its health system under common ownership wh en the compounded drug products are administered only to patients within the hospital or health system. Tr u e.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Post - Test Questions A staffing request or concerns form regarding pharmacy working conditions may be accessed on the Board’s websi te. Tr u e.

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov

D epar t m ent of H eal t h P r of essi ons ww w.dhp.virginia.gov Contact Infor mation Department of Health Professions Virginia Board of Pharm acy Perimeter Cent er 9960 Mayland Drive, Suite 300 Henrico, VA 23233 (804) 367 - 4456 pharmbd@dhp.v irginia.gov