Shanna Hampton
Buda,TX
Summary
Dynamic director and leader in compliance and regulatory affairs with extensive expertise pharmacy and healthcare. Proven ability to enhance institutional knowledge across teams by sharing professional insights and incorporating industry best practices. Skilled in developing and implementing standard operating procedures, ensuring technical documentation aligns with evolving regulatory standards, and advising senior management on critical product development and lifecycle management. Strong communicator with the ability to navigate complex regulatory landscapes while educating stakeholders on federal and international requirements, ultimately facilitating informed decision-making and effective compliance strategies. Experienced in large global operations as well as small businesses.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Director, Texas Compassionate Use Program
Regulatory Services Division, Texas Department of Public Safety
08.2021 - Current
- Serve as a subject matter expert and liaison to regulatory personnel. Manage licensing of facilities, employees, and physician registrations. Provide technical assistance and training to physicians participating in the program. Evaluate and provide feedback on inspections and CAPA (corrective and preventative action). Create and implement product approval requirements. Revise rules around testing and product safety as well as patient database information. Participate in weekly meetings with regulators across the nation and Health Canada. Regularly participate in federal discussions with FDA and DEA. Research and provide suggestions for future requirements and education for the medical program. Work closely with other agencies to create a program that falls within the framework of the current legislation. Help identify and address patient barriers. Communicate and provide information and recommendations to legislators regarding current statutes. Develop licensure and selection criteria to satisfy legislative intent. Implement new bill requirements and provide information to internal and external stakeholders. Manage program budget and report to legislative liaison. Work closely with legislative counsel and provide direction and information regarding federal guidelines and state guidelines. Work with international regulators on best practices and developing standards using cGMP and USP guidelines. Set up direct relationship with USP for developing new standards and requirements.
Pharmacist (Consultant)
ACP, Alive + Well, MedSavers
05.2019 - 01.2026
- Responsible for new compounded formulations, obtaining information from manufacturers and distributors, training new employees, dispensing medications, aiding functional medicine providers. Maintain controlled substances inventory. Maintain multi-state licensure for pharmacists and pharmacies. Gather information for audits and initiate investigations as warranted. Develop compliant package inserts for compounded medications and for devices. Initiate product research for novel dosage forms and provide education to staff, patients, and providers on safety and use. Maintain contracts with large group prescribers and partner with them in compounded medication delivery to very specific patient groups. Additionally, create plans to ramp up compounding to a large scale to accommodate partnerships. Work closely with these groups to provide effective and clear patient and safety information. Create groups for purchasing and provide sourcing guidance to ensure highest quality. Provide detailed training to pharmacists and technicians regarding relevant USP requirements and how to implement these into practice.
Pharmacist (PRN – as needed)
Sam’s Club Pharmacy, San Marcos, TX
04.2006 - 01.2022
- PRN schedule as a retail pharmacist at various Sam’s Club pharmacies in the Austin and San Antonio areas. Responsibilities included counseling patients, working with team members, maintaining controlled substance inventory requirements, filling prescriptions, and providing immunization services.
Pharmacist-in-Charge
Hunter’s Creek Pharmacy, New Braunfels, TX
10.2019 - 04.2020
- Staff pharmacist, promoted to pharmacist in charge within one month. In charge of all pharmacy functions and staff. Focus was on pain management and decreasing opioid dependence in patients. Dispensed compound and commercial medications. Successfully increased profits while decreasing operating expenses.
Director, Pharmaceutical Resource Center
Fagron, Inc. (f/k/a Humco) Austin, TX
10.2015 - 05.2019
- Served as a subject matter expert for compounding and pharmacy related needs, including business development in the United States and internationally. Continuously worked with legislators, government agencies, and groups of interest on pharmacy topics. Worked with the Sales Team and Innovation Team; provided research and direction regarding US and international markets. Worked directly with sales to develop strategies and new market areas. As R&D team leader, oversaw the development of new products and kits as well as corresponding product literature and safety literature. Interfaced with clients on technical and clinical queries and provided direction to pharmacists on best practices. Provided direction to assist pharmacists and technicians with introducing or expanding the practice of compounding in their business and in developing new products or dosage forms. Provided guidance to new businesses on start-up procedures. Continuously acquired industry knowledge to assist with market segmentation analysis for compounding and prescription products, supplements, and OTC products. Assisted in maintaining appropriate state, federal, and international licensing for the company. Coordinated with Quality Control team on certificates of analysis documents and safety data sheets to comply with Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Managed global API sourcing.
PIC and Staff Pharmacist
CommUnityCare Pharmacy, Austin, TX
10.2014 - 05.2018
- Operated as the pharmacist in charge for 18 clinic (Class D) pharmacies. On a monthly basis, performed inspections and addressed any outstanding issues with the clinic staff. On an annual basis, provided in-service training at each clinic on medications located in each pharmacy. I worked closely with the Director on 340b contracts and was responsible for FDA relabeling within the pharmacy.
Clinical Pharmacist (Home Infusion)
CarePoint Pharmacy (Bioscrip)
04.2014 - 12.2016
- Provided direction on USP 797 and 795 to make changes within the pharmacy and create SOPs. Responsible for sterile and non-sterile preparations and calculations. I worked with various teams across Austin to help provide patients with home infusion services.
Pharmacist in Charge
ALK-Abello
07.2009 - 01.2014
- Responsible for becoming a subject matter expert in immunotherapy treatment and prescribing. Worked with international markets on developing successful entry of products into these new markets. Evaluated patient lab reports and created treatment plans for physician approval. Responsible for licensing in every state for both pharmacy and for pharmaceutical manufacturing. Maintained safety information for patients and providers. Maintained a high level of compliance for sterile and non-sterile compounding as well as creating and updating SOPs for all pharmacy functions.
Education
PharmD -
University of Texas
Austin, TX01-2005
BS - Chemistry
Angelo State University
San Angelo, TX01-1997
Certification Program - Healthcare Law
Texas A&M School of Law
05-2027
Skills
- Strategic planning
- Verbal and written communication
- Decision-making and leadership
- Experienced in 503A and 503B pharmacy regulatory requirements
- Healthcare regulation and compliance
- Licensing in healthcare and pharmacy across the US and some international markets
- Experienced compounder with pharmacy business experience
Certification
- Texas Pharmacist License #43408
- Louisiana Pharmacist License #PST.019373
- Mississippi Pharmacist License #P12176
- Arizona Pharmacist License #S0020118
- Maryland Pharmacist License #25135
- Tennessee Pharmacist License #37490
- Certification in Medical Cannabis for Health Care Providers
- Certification in Pharmacogenomics.
- IV certified
- Currently obtaining BCMAS and PMP Certification, current immunizer and BLS current
- Enrolled in Healthcare Compliance Certification program
Timeline
Director, Texas Compassionate Use Program
Regulatory Services Division, Texas Department of Public Safety
08.2021 - Current
Pharmacist-in-Charge
Hunter’s Creek Pharmacy, New Braunfels, TX
10.2019 - 04.2020
Pharmacist (Consultant)
ACP, Alive + Well, MedSavers
05.2019 - 01.2026
Director, Pharmaceutical Resource Center
Fagron, Inc. (f/k/a Humco) Austin, TX
10.2015 - 05.2019
PIC and Staff Pharmacist
CommUnityCare Pharmacy, Austin, TX
10.2014 - 05.2018
Clinical Pharmacist (Home Infusion)
CarePoint Pharmacy (Bioscrip)
04.2014 - 12.2016
Pharmacist in Charge
ALK-Abello
07.2009 - 01.2014
Pharmacist (PRN – as needed)
Sam’s Club Pharmacy, San Marcos, TX
04.2006 - 01.2022
BS - Chemistry
Angelo State University
PharmD -
University of Texas
Certification Program - Healthcare Law
Texas A&M School of Law