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Five Myths About USP<800>

2020-02-10T16:55:56-06:00November 25th, 2019|Categories: USP 800|

By Ernest P. Gates. Jr., RPh, FASCP, FIACP, FACA

For nearly 200 years, the United States Pharmacopeia – or USP – has been setting standards for pharmaceuticals and the practice of pharmacy. However, its latest chapter – like any new standard or regulation – is creating uncertainty among the pharmacy community. USP <800>, which governs pharmacy handling of hazardous medication, takes effect on December 1, and many states will require compliance as of that date.

There are many myths surrounding USP <800>. Below are five with which you should be familiar, to avoid falling into a trap of non-compliance with this important new chapter.

Myth: My pharmacy prepares hazardous drugs but I don’t need to make changes to my practice to comply.

Fact: USP <800> requires a lab with negative pressure ventilation, including a minimum of 12 air exchanges per hour. If you do not have a negative pressure lab to compound these drugs, and you are in a state that is enforcing USP <800>, or you ship to a state that is enforcing the chapter, you will need to cease operations until you have created such a facility. You should be aware that to create a negative pressure environment you will need to vent to the outside either through the roof or a side wall. This will require new ductwork or a relocation of your lab.

Myth: My state is not enforcing USP <800> so I am all set.

Fact: Even if your state is not implementing USP <800> as of December 1, you must be compliant to ship medication to any state that is enforcing it. If you are not compliant you must cease out-of-state shipping to these states until you bring your lab into compliance. Also, it is important to not rest on your laurels. Even states that do not plan to implement USP <800> by December will likely implement it eventually. Those pharmacies that first saw USP <800> approaching, or something like it, and built to that specification are in a much better place today. Even if it is not required now, you should plan as though it soon will be. Separate and apart from your board of pharmacy, the Occupational Safety and Health Administration (OSHA) has requirements for handling hazardous drugs that are in effect now.

Myth: USP <800> involves relatively quick fixes to my lab.

Fact: USP <800> compliance is anything but quick or easy. If you do not currently comply, you will need to install new equipment that must first be ordered and then professionally installed. Separate and apart from any equipment orders, you likely will need to make design and layout changes to your lab and pharmacy unless your facilities were built in anticipation of USP <800>. Design and layout changes can involve moving walls and replac-ing or installing new electrical and plumbing systems. If you have renovated any type of space before, including your kitchen or bathroom at home, you know how hard it is to get designs, bid out the work, hire a contractor and secure permits. You should not underestimate the time involved.

Myth: I am not concerned with USP <800> because I don’t compound.

Fact: All pharmacies – even retail only – must ensure compliance with USP <800>, in those states where it is being enforced. For instance, USP <800> has require-ments for handling finished dosage forms that are on the NIOSH Hazardous Drug List. A careful review of that list and USP <800> are necessary to ensure compliance. You can download USP <800> here.

Myth: If I am not compliant with USP <800> and I dispense hazardous drugs, my only concern is my state board of pharmacy.

Fact: Pharmacies that handle hazardous medications and do not comply are at risk of punitive action on multiple fronts. For example, an employee or former employee can allege harm to themselves or an unborn child and file a legal action. Also, OSHA always has the authority to issue stiff fines on the basis of an unsafe workplace.

Fortunately, you do not have to go it alone. There are consultants who can help navigate the thicket of regulatory and design issues to achieve compliance.USP <800> will create a safer workplace for you and your team. What we now know about hazardous drugs we didn’t necessarily know just a few years ago. Change is always hard, and sometimes costly, but it usually puts us in a better place when done.

Ernest P. Gates. Jr., RPh, FASCP, FIACP, FACA is President of Gates Healthcare Associates in Middleton, Mass. To learn more about Gates Healthcare Associates, or for help with USP <800> compliance, go to www.gatesconsult.com.

Ernie Gates

Ernest P. Gates. Jr., RPh, FASCP, FIACP, FACA

Memories of 50 Years as a Woman Pharmacist…..

2019-10-10T17:05:16-05:00October 10th, 2019|Categories: Blog, News Release|

Women Pharmacist Day, October 12, 2019, is a wonderful opportunity to recognize those women who have made – and continue to make – contributions to pharmacy practice and our patients’ lives.

Fifty years ago, I became a registered pharmacist. I’ll be honest—some days it seems like yesterday; and other days, it seems like forever ago.  Oh, the changes I have seen through the years in equipment, practice, education, and gender of pharmacists.

Changes for women, as well as pharmacy practice, are enormous.  Women are now 50% of pharmacy students, computers are the norm, and pharmacists are counseling patients.  Pharmacy practice today is nothing like 50 years ago.

When I finished pharmacy school, there were only seven women in my graduating class of 77. We hung together and most of us joined Kappa Epsilon, the women’s professional pharmacy fraternity on our campus. Today, this organization still supports women in pharmacy but has evolved with the times and welcomes men as well as women.

Upon graduation, I took a staff pharmacist position with a small chain.  At this time, retail pharmacists made the most money and most retail pharmacies were owned and operated by individual pharmacists.  In many cases, the men were paid more than the women.

Because you were a young female, everyone would always ask to see the pharmacist and then tell you that you were too young to be a pharmacist and they wanted to talk to the “man” pharmacist.  Many customers would leave rather than have a female help them (that was usually because they wanted to buy condoms which were kept behind the counter!).

Since there were few women pharmacists older than me, most of my mentors were men.  However, I attended many pharmacy meetings which afforded me the opportunity to meet many women who were “firsts” and pioneers in pharmacy who then became my mentors.  To name a few: Marjorie Coghill, Metta Lou Henderson, Joy Donaldson, Gloria Francke (first female to receive the Remington Honor Medal), Mary Lou Andersen (first female Speaker of APhA House of Delegates among other firsts), Evelyn Timmons (first female president of ACA), Mary Munson Runge (first female president of APhA), Hazel Pipkin (first female president of Texas Pharmacy Association) and many others.  Without these women and the trails they blazed, many of us women would never have reached the leadership positions that we have enjoyed through the years.

So on behalf of the American College of Apothecaries and the American College of Veterinary Pharmacists, I want to say “Thank You” to the women pharmacists who came before me and helped pave the way, to the women pharmacists who supported me in pharmacy school and the early years of my practice, to the women pharmacists who work tirelessly everyday to help improve their patients’ health and the health of our communities, to the women pharmacists who serve on the board, committees, and faculty of the American College of Apothecaries and the American College of Veterinary Pharmacists, and to the pharmacy students who will be the women pharmacists of the future.


Susan Bartlemay
Susan Bartlemay, RPh, FACA, FAPhA
Executive Vice President
American College of Apothecaries  |  American College of Veterinary Pharmacists

Susie Business 2
Susan Bartlemay Executive Vice-President American College of Apothecaries American College of Veterinary Pharmacists

ACA’s Response to the Update on USP Compounding Standards

2019-09-25T14:45:00-05:00September 25th, 2019|Categories: News Release, USP 795, USP 797|

On September 23, 2019, ACA received notification that due to ongoing appeals, implementation of proposed changes to USP Chapters 795 and 797 will not occur on December 1, 2019. This is good news for compounding pharmacy: the scope of the revisions to USP Chapters 795 and 797 – and the impact that the current revisions as written would have on maintaining patients’ access to compounded medications and on the preservation of local, independent community pharmacies’ ability to continue to compound—were too great.

ACA is committed to providing compounding training that reflects the USP Chapter Standards. We are in the process of updating the curricula for our 2020 live and online courses to reflect the proposed changes as they are currently written. Once USP makes a decision to deny or remand the ongoing appeals to Chapters 795 and 797, and communicates a new implementation schedule, we will adjust our revisions and training updates accordingly on our website.

If you have any questions about ACA compounding training or the inclusion of USP Chapter Standards in our curricula, please contact us at training@acainfo.org. Click here to read the notice from USP.



Susan Bartlemay, RPh, FACA, FAPhA
Executive Director | CEO
American College of Apothecaries

Recognize & Celebrate Pharmacy With Recognition Days

2020-01-13T10:07:16-06:00September 25th, 2019|Categories: News Release|

Professional Awareness Days are a great opportunity to show your appreciation for the hard work that your staff does every day and market your pharmacy at the same time. There are several notable dates coming up, so start planning. For your convenience, we’ve compiled some links and ideas to get you started.

Throughout the Weeks Ahead:

  • Ahead of time: post signs around your pharmacy and on your website and social media alerting your patients about the upcoming recognition day and asking them to join you in showing their appreciation to your staff
  • Include information for your patients about the many services you and your staff provide and how the profession of pharmacy helps keep them healthy
  • Make each recognition fun & be creative — take photos of the events and post online
  • Use the official hashtags for each special day
  • Use the links below to discover more ways to promote each event!

Key Dates

September 25
World Pharmacists Day
#WPD2019 #WorldPharmacistsDay

Theme:  “Safe and effective medicines for all”

The theme for 2019 aims to promote pharmacists’ crucial role in safeguarding patient safety through improving medicine’s use and reducing medication errors. Show your support with graphics and a profile frame from the International Pharmaceutical Federation (FIP).

October 1-31
American Pharmacists Month

Theme: “Pharmacists: Easy to Reach, Ready to Help”

Visit the APhM website for marketing and promotional materials to wear or display and for event ideas for your practice setting.

October 12
National Women Pharmacists Day

Celebrate the significant gains that women have made in pursuing careers in pharmacy. Honor the trailblazers who have made such progress possible and the women working in your pharmacy today. Download a toolkit of graphics and ideas from the WPD website.

October 15
Pharmacy Technicians Day

Show your appreciation to pharmacy technicians for the important role they play in your pharmacy. Recognize and celebrate their dedication and hard work.

The links above have been provided as informational resources and as tools for our members to use to promote pharmacists and pharmacy technicians.

Susan Bartlemay Selected to Lead ACA, ACVP, and ACA Foundation

2019-10-10T14:26:42-05:00September 19th, 2019|Categories: Blog|

Bartlett, Tennessee, September 19, 2019: The American College of Apothecaries, American College of Veterinary Pharmacists, and the ACA Research and Education Foundation have named Susan Bartlemay, RPh, FACA, FAPhA, as the organizations’ new Executive Vice President.  Bartlemay was selected to lead the pharmacy associations after a nationwide search and began her new role on September 6, 2019.

“We are confident that Susie Bartlemay will be an effective leader for the College as we enter our 80th year. Her professionalism and association management experience on the local, state, and national levels will be invaluable assets to our organizations and to our members,” said David Liebman, RPh, FACA, Chairman of the American College of Apothecaries Board of Directors.

“Since the beginning of my career, I have said that leading a national pharmacy association would be my dream pharmacy job. It is a dream job for any pharmacist who loves people and enjoys building relationships throughout the pharmacy profession. I couldn’t be happier and more excited about being the EVP/CEO of ACA, ACVP, the ACA Foundation, and PPSI,” said Bartlemay. “Right now, independent pharmacy and veterinary pharmacy are truly at a crossroads. But our organizations have a powerful ability to propel the pharmacy profession forward through education, entrepreneurship, and fellowship.”

Bartlemay graduated from the University of Texas College of Pharmacy with a BS in Pharmacy in 1969 and earned a MS in Management and Administrative Science from the University of Texas at Dallas in 1978. She brings over 25 years of experience in community pharmacy to her new role, including 15 years as an independent pharmacy owner and a position as Director of Operations for a small chain of local pharmacies.

Bartlemay also has extensive leadership experience with both state and national pharmacy associations. Her career has included involvement with the Dallas Area Pharmacy Association & Texas Pharmacy Association holding every elected position in both organizations and serving on and chairing many committees.

From this local involvement, she became involved in the American Pharmacists Association (APhA) and rose to serve as Speaker of the House of Delegates. Bartlemay also served as Vice-Chair of the APhA-PAC Board of Governors. She is a past president of Kappa Epsilon Professional Pharmacy Association.

As a small business owner in Allen, Texas, Bartlemay knew the importance of civic engagement and served on the Allen Chamber of Commerce as a Board Member, Officer, and President as well as the city’s Planning & Zoning Commission, Economic Development Corporation and nine years on City Council (one year as Mayor Pro Tem).

Bartlemay is a past recipient of the Bowl of Hygeia, the Outstanding Alumnus award from the UT College of Pharmacy, the Vanguard Leadership Award, and the Key of Excellence from Kappa Epsilon, and is a fellow of the American College of Apothecaries and the American Pharmacists Association.

Bartlemay’s selection has the support of the leadership of the organizations. “Susie Bartlemay’s background as a pharmacy owner, as operations manager, and association parliamentarian gives her the clinical, business, and managerial expertise to carry out the College’s mission to advance the entrepreneurial spirit of independent pharmacy,” said Steve Pryor, PharmD, FACA President of the American College of Apothecaries.

“Susie Bartlemay brings exciting new leadership skills to the American College of Veterinary Pharmacists and our board looks forward to working with her to develop programs and services in support of veterinary pharmacy,” said Gigi Davidson, BSPh, FACVP, DICVP, President of the American College of Veterinary Pharmacists.

Susie Business 2
Susan Bartlemay
Executive Vice-President
American College of Apothecaries
American College of Veterinary Pharmacists

On-Demand CE: CBD Update–Having the Facts To Answer Your Patient’s Questions

2019-07-14T12:24:09-05:00May 1st, 2019|Categories: Medical Cannabis|

CBD Update: Having the Facts To Answer Your Patient’s Questions


$50 for ACA, ACVP, or PPSI Members, $25 for Student & Technician Members; $75 for non-members

Recently, it has become almost impossible to pick-up the newspaper or watch the evening news without seeing a story, advertisement, or a “medical professional” weighing-in either for a new CBD product, a new use for CBD, or against the ever increasing use and societal acceptance of CBD as a legitimate product to treat ailments.

Just as healthcare professionals are being bombarded with these daily “revelations”, so too are our patients. With the many endorsements from users of all walks of life, fame, and social status, it is understandable that our patients will not only hear about CBD, but also be confused enough to seek an “experts” opinion on its use.

Pharmacists, as America’s drug experts must become thoroughly familiar with this “new” drug, just as we do for all the other new drugs that enter the market. There are now sufficient studies and clinical trials regarding medical uses for CBD, so much so, that all Pharmacists should be aware that CBD does possess valid, documentable, medical benefits for many illnesses.

We must embrace the concept that this drug will not only be tried by many, but its use, possible drug interactions, and questionable quality from product to product, will add uncertainty and apprehension in the public’s mind leading at best, to questionable positive outcomes, or possible severe ADR’s.

When Pharmacists become thoroughly familiar with CBD, we will be more comfortable providing our patients with factual, high-quality answers to their CBD questions.

*This program will be available on-demand approximately 2-3 days after the live transmission.


2019 ACA Member of the Year Awarded to Marisol Lopez

2019-02-27T10:16:07-06:00February 21st, 2019|Categories: News Release|Tags: |

ST. PETE BEACH, FL, February 8, 2019: The American College of Apothecaries presented the 2018 ACA Member of the Year Award to Marisol Lopez, RPh, MPH, FACA, FACVP, of f Trujillo Alto, Puerto Rico.

The award, established in 2013, recognizes an ACA Member for exceptional accomplishment and effort in serving his or her community and promoting community pharmacy through mentoring, entrepreneurship, and education, as well as support of the ACA.   The presentation was made during the Presidents’ Banquet Friday evening, at the College’s 2019 Annual Educational Conference hosted at the Don CeSar.

Marisol Lopez excels in the field of education and mentoring as she has dedicated herself to the promotion of community pharmacy and the continued development of pharmacy professionals.

As an ACA Fellow, Lopez has served the organization through roles on the ACA Board of Directors and as a compounding training class instructor. She has been instrumental in expanding ACA’s compounding training into the Caribbean and is an outstanding teacher and mentor to class participants.

A 1990 graduate of the University of Puerto Rico (UPR) with a bachelor’s degree in Pharmaceutical Sciences, Lopez completed a Master’s degree in Public Health with a major in Public Health Administration in 2007.

Lopez works as an Adjunct Professor at the School of Pharmacy of Puerto Rico and has offered continuing education presentations for the Continuing Education Division of the School of Pharmacy, University of PR, and the Puerto Rico Pharmacists Association (Colegio de Farmaceuticos de PR). In addition, Lopez has collaborated in the development of the compounding sections of the Pharmacy Act of Puerto Rico.

In 2014, Lopez received the honor of being named the Innovative Pharmacist of the Year Excellence in Innovation Award by the Puerto Rico Pharmacist Association, sponsored by Upsher-Smith Laboratories.

At the present, Lopez is the President of International Society of Pharmaceutical Compounding (ISPhC) based in Spain, a member of the International Academy of Compounding Pharmacists (IACP) and a Fellow of the American College of Apothecaries (ACA) and the American College of Veterinary Pharmacists (ACVP).

ACA 2018 Member of the Year Marisol Lopez with 2018 Chairman of the Board Ryan Oftebro

US Surgeon General Requests Input on Community Health Initiatives

2018-10-24T16:40:56-05:00October 24th, 2018|Categories: Blog|

The Office of the Surgeon General has commissioned a report demonstrating the intersection between health and the economy in order to show that investments in community health have the potential to improve not only the well-being, but also the prosperity of communities.

Dr. Jerome Adams believes preventing chronic diseases and behavioral health issues is more cost effective than treating them. Investments in community health is a key prevention strategy to produce greater individual and community health and well-being and ultimately lead to greater economic and overall prosperity. The Surgeon General will compile the available evidence and best practices documenting the connection between private sector investment in the health of their employees and communities and collective prosperity, and issue a report to share the evidence, inspire future research and provide tools and resources for effective, efficient community health investments that produce results.

The Surgeon General wants to build upon the community health work that has already been done and would like to hear from you about the initiatives you are doing to address community health and prosperity. 

Independent pharmacists are in a unique position as front-line health care providers to interact with and influence the community health through innovative programs. Click here to submit your ideas, examples, and experiences to Docket No. CDC-2018-0082 in the Federal Register.

Call For Nominations

2018-10-23T15:51:55-05:00October 23rd, 2018|Categories: Blog|

Nominations are now open for the 2019 ACA Board of Directors. This year, there is one Regional Director seat for which candidates are sought as well as nominees for the position of ACA Vice President.

ACA Members may submit themselves or a colleague as a potential candidate to the 2018 Nominating Committee no later than November 2, 2018 using the link below.

Board&nbspPosition Eligible for Nominations Term
Vice President Any Full Fellow in good standing with the College. The Vice President shall serve for one year or until such time as their successor shall be elected or selected as provided by the ACA Constitution. The Vice President automatically becomes the ACA President-Elect, ACA President and then ACA Chairman.
Region 2 Any Full Fellow from:
District of Columbia, Florida, Georgia, North Carolina, Puerto Rico, South Carolina, Virginia and West Virginia
For a three-year term expiring in 2022.
Regional Director Marisol Lopez will
be standing as a candidate.

The Regional Director shall be elected by vote of the Full Fellows within the Region represented from nominees presented by the Region. Proper ballots shall be prepared and distributed under the direction of the Vice President of Operations. Such elections must be completed no later than one month before the date of the annual meeting. Duly elected Directors shall be seated at the annual meeting of the College immediately following their election.

The Vice President shall be elected annually by a majority of the votes of Full Fellows cast by ballot. Ballots shall be prepared and distributed under the direction of the Vice President of Operations. Such elections must be completed no later than one month before the date of the annual meeting. (The ballot shall be conducted by the procedure outlined in the duties of the Nominating Committee.)

Nominations Committee: The Nominations Committee shall be composed of Fellows in good standing with the College in addition to David Liebman, ACA President, and the ACA’s Past Presidents. Ryan Oftebro, ACA Past President, serves as Chairman.

Objectives: To recognize and seek qualified nominees for the Vice President position of the association.


  • Review requirements for nominees.
  • Review duties of each elected officer as outlined in the Bylaws.
  • Provide ACA with a slate of officers that is balanced in terms of new as well as experienced officers.
  • Provide ACA with a slate of officers that is balanced in terms of membership (e.g. ACA, ACVP, demographics, etc.).

ACA Exhibits at Puerto Rico Pharmacists Association Meeting

2018-10-11T13:05:36-05:00August 16th, 2018|Categories: News Release|Tags: |

ACA Regional Director Marisol Lopez, RPh, MPH, FACA, FACVP represents the American College of Apothecaries at the Puerto Rico Pharmacists Association (CFPR) Meeting August 16-19 in Rio Grande, Puerto Rico.

ACA began teaching Fundamental and Dermatology compounding courses in Puerto Rico in January 2018 thanks to a special arrangement with Columbia Central University in Caguas.

For more information, visit: acainfo.org/puertorico

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