Compounding Pharmacies and Accreditation
Mark Drugs Roselle was the first accredited compounding pharmacy in the state of Illinois and the only fully accredited compounding pharmacy in northern Illinois or in the Chicagoland area for both sterile and non-aseptic preparation of products.
Mark Drugs Northshore, located in Deerfield IL, is presently in the process of obtaining the same type of accreditation status that the Roselle location maintains.
- What are Compounded Medicines?
- Compounded medications are necessary for a variety of reasons.
- Why is Accreditation Important?
- The Pharmacy Compounding Accreditation Board Process
- Examples of specific quality and safety standards include:
- For more information contact our pharmacists or PCAB:
What are Compounded Medications?
Compounded medications are prescriptions that are written by a physician, veterinarian or other legally authorized prescriber and prepared for an individual patient. They are not commercially available; rather, they are prepared by a pharmacist to meet an individual’s unique needs as determined by the prescriber.
Compounded medications are necessary for a variety of reasons.
- When a child needs a dose smaller than the manufactured dose.
- When a patient cannot tolerate an inactive ingredient in a manufactured medicine.
- When a doctor believes a medicine is needed for his or her patient, but a manufacturer has discontinued the medicine for economic reasons.
Compounded medications are safe and effective treatment options for patients. Prescribers customize prescriptions for patients when they believe compounded medications are that patient’s best treatment option.
Why is Accreditation Important?
Compounding medications is an integral part of the practice of pharmacy, and with the demand of patient-specific compounded medications increasing each year, there is a need for an enhanced, profession-wide system of standards by which each compounding pharmacy can test its quality processes. While compounding pharmacy is regulated by the state, accreditation is an even more comprehensive way to ensure a compounding pharmacy is meeting the highest quality and safety standards.
Pharmacists also want to give patients and prescribers a way to select a quality pharmacy. The pharmacies seeking PCAB™ Accreditation want to be able to demonstrate that they are “the best.”
The Pharmacy Compounding Accreditation Board Process
The Pharmacy Compounding Accreditation Board (PCAB) is a not-for-profit corporation formed by eight national pharmacy organizations that recognized the need for a national standards organization for compounding pharmacy. Together, these leading organizations developed the industry principles, policies and standards for the practice of compounding pharmacy, as well as the PCAB Accreditation criteria and processes.
Examples of specific quality and safety standards include:
PCAB Accredited compounding pharmacies can use only certain chemicals from highly reliable suppliers.
PCAB Accredited compounding pharmacists and their technicians must receive regular, specialized training.
PCAB Accredited compounding pharmacy facilities must meet design and other related standards to help ensure the area is clear and free of contamination.
PCAB Accredited compounding pharmacies must meet or exceed USP <795> standards for non-sterile compounding and/or USP <797> standards for sterile compounding.
PCAB Accredited compounding pharmacies agree to adhere to the PCAB “Principles of Compounding.”
Pharmacies seeking accreditation must submit documented proof that they meet PCAB quality standards, submit their policies and procedures for regular review, and open their doors to regular physical inspections.
PCAB was founded by the American College of Apothecaries, American Pharmacists Association, International Academy of Compounding Pharmacists, National Alliance of State Pharmacy Associations, National Association of Boards of Pharmacy National Community Pharmacists Association, National Home Infusion Association and United States Pharmacopeia.
More detailed information about PCAB™ and the PCAB™ Accreditation process can be found on its Web site at www.pcab.org.
For more information contact our pharmacists or PCAB:
Tom Murry, PharmD, Esq
PCAB Executive Director
I. WE HAVE A LEGAL DUTY TO SAFEGUARD YOUR PROTECTED
HEALTH INFORMATION (PHI).
We are legally required to protect the privacy of your health information. We call this information protected health information, or PHI for short, and it includes information that can be used to identify you that we’ve created or received about your past, present, or future health condition, the provision of health care for you, or the payment of this health care. We must provide you with this notice about our privacy practices that explains how, when, and why we use and disclose your PHI. With some exceptions, we may not use or disclose any more of your PHI that is necessary to accomplish the purpose of the use or disclosure. We are legally required to follow the privacy practices that are described in this notice.
However, we reserve the right to change the terms of this notice and our privacy policies at any time. Any changes will apply to the PHI we already have. Before we make an important change to our policies, we will promptly change this notice and post a new notice in our checkout area.
II. HOW WE MAY USE AND DISCLOSE YOUR PROTECTED HEALTH INFORMATION.
We use and disclose health information for many different reasons. For some of these uses or disclosures, we need your specific authorization. Below, we describe the different categories of our uses and give you some examples of each category.
A. Uses and Disclosures Relating to Medication Treatment, Payment, Or Pharmacy Operations.
We may use and disclose your PHI for the following reasons:
1. For medication treatment. We may disclose your PHI to physicians, nurses, medical students, and other health care personnel, who provide you with health care services or are involved in your care. For example, if you’ve been prescribed a medication for a knee injury, we may disclose your PHI to the physical rehabilitation department in order to coordinate your care.
2. To obtain payment for medication or services provided to you. We may use and disclose your PHI in order to bill and collect payment for the medication or services provided to you. For example, we may provide portions of your PHI to our accounting department in order for payment to be achieved for the medication or services we have provided to you. We may also provide your PHI to our business associates, such as billing companies, claims processing companies, and others that process our medication or services claims.
3. For pharmacy operations. We may disclose your PHI in order to operate this pharmacy. For example, we may use your PHI in order to evaluate the performance of the employee who provided the services to you. We may also provide your PHI to our accountants, attorneys, consultants, and others n order to make sure we’re complying with the laws that affect us.
B. Certain Uses and Disclosures Do Not Require Your Authorization. We may use and disclose your PHI without your authorization for the following reasons:
1. When a disclosure is required by federal, state, or local law, judicial or administrative proceedings, or law enforcement. For example, we make disclosures when a law requires that we report information to government agencies and law enforcement personnel when ordered in a judicial or administrative proceeding.
2. For pharmacy oversight activities. For example, we will provide information to assist the government when it conducts an investigation or inspection of a pharmacy or organization.
3. For research purpose. In certain circumstances, we may provide PHI in order to conduct medical research.
4. To avoid harm. In order to avoid a serious threat to the health or safety of a person or the public, we may provide PHI to law enforcement personnel or persons able to prevent or lessen such harm.
5. For specific government functions. We may disclose PHI of military personnel and veterans in certain situations. And we may disclose PHI for national security purposes, such as protecting the president of the United States or conducting intelligence operations.
6. For worker’s compensation purposes. We may provide PHI in order to comply with worker’s compensation laws.
7. Appointment reminders and health-related benefits or services. We may use PHI to provide appointment reminders or give you information about treatment alternatives or other health care services or benefits we offer.
C. Uses and Disclosures Require You to Have the Opportunity to Object.
1. Disclosures to family, friends, and others. We may provide your PHI to a family member, friend, or other person that you indicate is involved in your care or the payment for your health care services, unless you object in whole or in part. The opportunity to consent may be obtained retroactively in emergency situations.
D. All Other Uses and Disclosures Require Your Written Authorization. In any other situation not described in Sections IIA, B, and C, above, we will ask for your written authorization before using or disclosing any of your PHI. If you choose to sign an authorization to disclose your PHI, you can later revoke that authorization in writing to stop any future uses and disclosures (to the extent that we haven’t taken any action relying on the authorization).
III. WHAT RIGHTS YOU HAVE REGARDING YOUR PHI
You have the following rights with respect to your PHI:
A. The Right to Request Limits on Uses and Disclosures of Your PHI. You have the right to ask that we limit how we use and disclose your PHI. We will consider your request but are not legally required to accept it. If we accept your requests, we will put any limits in writing and abide by them except in emergency situations. You may not limit the uses and disclosures we are legally required or allow to make.
B. The Right to Choose How We Send PHI to You. You have the right to ask that we send information to you to an alternate address (for example, sending information to your work address rather that your home address) or by alternate means (for example, e-mail instead of regular mail). We must agree to your request so long as we can easily provide it in the format you request.
C. The Right to See and Get Copies of Your PHI. In most cases, you have the right to look at or get copies of your PHI that we have, but you must make the request in writing. If we don’t have your PHI but we know who does, we will tell you how to get it. We will respond to you within 30 days after receiving your written request. In certain situations, we may deny your request. If we do, we will tell you in writing our reasons for the denial and explain your rights to have the denial reviewed. Instead of providing the PHI you requested, we may provide you with a summary or explanation of the PHI as long as you agree to that.
D. The Right to Get a List of the Disclosures We Have Made. You have the right to get a list of instances in which we have disclosed your PHI. The list will not include uses or disclosures that you have already consented to, such as those made for treatment, payment, or services, directly to you, to your family, or others. The list also won’t include uses and disclosures made for national security purposes, to corrections or law enforcement personnel, or before April 15, 2003.
We will respond within 60 days of receiving your request. The list we will give you will include disclosures made in the last three years unless you request a shorter time. The list will include the date of the disclosure, to whom PHI was disclosed (including their address, if known), a description of the information disclosed, and the reason for the disclosure. We will provide the list to you at no charge.
E. The Right to Correct or Update Your PHI. If you believe that there is a mistake in your PHI or that a piece of information is missing, you have the right to request that we correct the existing information or add the missing information. You must provide the request and your reason for the request in writing. We will respond whiting 60 days of receiving your request. We may deny your request in writing if the PHI is (i) correct and complete, (ii) not created by us, (iii) not allowed to be disclosed, or (iv) not part of our records. Our written denial will state the reasons for the denial and explain you right to file a written statement of disagreement with the denial. If you don’t file one, you have the right to request that your request and our denial be attached to all future disclosures of your PHI. If we approve your request, we will make the change to your PHI, tell you that we have done it, and tell others that need to know about the change to your PHI.
F. The Right to Get This Notice by E-mail. You have the right to get a copy of this notice by e-mail. Even if you have agreed to receive notice via e-mail, you also have the right to request a paper copy of this notice.
IV. HOW TO COMPLAIN ABOUT OUR PRIVACY PRACTICES
If you think that we may have violated your privacy rights, or you disagree with a decision we made about access to your PHI, you may file a complaint with the person listed in Section V below. You also may send a written complaint to the Illinois State Board of Pharmacy. We will take no retaliatory action against you if you file a complaint about our privacy practices.
V. PERSONS TO CONTACT FOR INFORMATION ABOUT THIS NOTICE OR TO COMPLAIN ABOUT OUR PRIVACY PRACTICES
If you have any questions about this notice or any complaints about our privacy practices, or would like to know how to file a complaint with the Secretary of the Department of Health and Human Services, please contact Mark Drugs Pharmacy’s Pharmacy Manager at 384 E. Irving Park Road, Roselle, IL 60172: phone (630) 529-3400; fax (630) 529-3429: email (firstname.lastname@example.org)
VI. EFFECTIVE DATE OF THIS NOTICE
This notice went into effect on April 2003.
Welcome to the Mark Drugs Pharmacy and Drug Store Museum. Our pharmacy museum showcases an extensive collection of historical pharmaceutical apothecary and artifacts that remind us of the important role that drug stores have played in America. We are located in the Chicagoland area, at 384 E. Irving Park Road, Roselle, Illinois.
Click here to view the Mark Drugs Museum Video on YouTube.
Highlights of the Mark Drugs Museum:
1872 Prescription Log
1914 Soda Fountain
1930s & 1940s Dental Aids
Antique Cash Register
Antique Poison Bottles
Balances and Scales
Bromo Seltzer Dispenser
Ceramic Beds Pans
Chemical Paper Stock Containers
Collection Lilly Herbs
Discontinued Narcotic Bottles
Labels Under Glass (LUG)
Merck Pharmacy Stock Bottles
Mortar and Pestle
Numbered Pharmacy Drawer
– Pulls circa 1890
Pharmacy in Pictures, 40 print
– set by Park Davis & Co.
Pharmacy Reference Library
Pharmacy Stained Glass
Pharmacy Stock Bottles
Turn of the Century
– Stock Bottles
Mark Drugs regularly hosts presentations on a variety of topics.
Our Roselle facility may be set-up with either simple chairs (42 seats) or in a conference format with tables and chairs (24 seats). Dry erase boards, paper tear sheets and screens for multi-media presentations are available.
Our location in Deerfield is suitable for simple chairs (40) and also has a screen suitable for powerpoint or other audio-visual presentations.
Several past presentations have included:
- Bio-Identical progesterone by Dr John Lee, MD
- Intestinal Dysbiosis and Probiotic therapy with Dr Kelly Karpa, PhD
- Autism, nutrition and Chiropractic manipulation with Dr. Charles Chapple, DC
- Questions and Answers about Health and Nutrition with Judy Manisco, LDN
- Bio-identical Hormone Therapy (BHRT) with Dr David Zeiger, DO
- Bio-identical Hormone Therapy (BHRT) with Dr Gail Gagnon, DO
- Bio-identical Hormone Therapy (BHRT) and Men’s Hormone Issues with Dr Paul Savage, MD
- HCG Weight Loss, weight gain, maintenance; the effects of stress and adrenal fatigue with Dr Marco De La Cruz, MD
- HCG Weight Loss with Dr Mayer Eisenstein, MD, JD, MPH
- Heavy Metals and Detoxification: Recognition and Treatment – hosted by Doctor’s Data of St. Charles, IL
- Veterinary Practice Manager’s Strategy Meeting and training – hosted by Pfizer labs
Mark Drugs welcomes community groups, Health Practitioners and others to inquire about the use of their facilities for professional and health related presentations, conferences and lectures. Catering on site is available thru local vendors.
For more information, schedule availability and fees, please contact us at: email@example.com
Mark Drugs has staff members to help you that are fluent in Spanish, Italian and English.
Our highly trained staff responds to the needs of our patients, veterinary clients and clinicians to prepare consistent, potent and pure products to meet all their clinical, nutritional and cosmeceutical needs. We have assembled an array of extremely skilled physicians, pharmacists, nutritionists, dietitians and other therapists to meet our clients’ and patients’ needs through a truly integrative format that utilizes principles of allopathic, homeopathic, nutritional and herbal medicine.
Prescription Compounding Specialists:
Mark H. Mandel Pharm D, IACP
Craig J. Batogowski Pharm D, IACP
History of Mark Drugs
We’ve Come a Long Way
Mark Drugs came to Roselle in 1990. At that time we purchased from Rick Cordts, the 400 square foot Roselle Medical Pharmacy at 225 E. Irving Park Rd., in the Roselle Medical Building (one block west of and opposite our current location). Originally opened in 1959, the store had thrived under the ownership of the loving, caring pharmacist, Daryl Lint and his wife Adeline. His quirky sense of humor gathered a devout following. Many of those patients, clients, customers and friends or their children and grandchildren who are still living in the area frequent the store today. Daryl sold the store to Rick Cordts in 1984 and retired. Daryl’s vision was of a friendly, fun place to work. We wanted to enjoy his job and provide a “good” living for his family while taking care of his friends and neighbors. We at Mark Drugs have those same goals.
In 1992 we discovered through a variety of attempts what our proper niche was. As independent after independent pharmacy in the chicagoland area went out of business, we had managed to survive. We did a self-examination to find out how we were different from our neighbors. That difference was prescription compounding. With that recognition, we soon expanded to 830 square feet and within a year had outgrown that space as well. We had to search for a new home. Our new home would consist of 3400 sq ft in the main drugstore with an upstairs storage area of 2600 sq ft. Within the store area, we created four state-of-the-art compounding laboratories, a museum of pharmacy and medicine and a dynamic nutrition and supplement department.
Mark Drugs Grows and Expands
Several months later we created a 1200 sq ft Home Health division across the driveway under a separate roof but as that business grew we soon experienced difficulties with the physical separation. We needed another bigger home that was all under one roof! By January of 1994 we were ready to expand and the space next to our facility became available. In a record time of only 3 months we had prepared an additional 5500 sq ft of retail area that housed our Home Health division and included an expanded museum, the Rose Garden Mastectomy Boutique, a 50 person classroom and lecture forum, a DME repair facility, exam and fitting rooms and professional offices for specialty physicians, staff members and a massage therapist. April of 1994 was our grand re-opening and we were ready to open one of the first pharmacies in the nation that had an integrated approach to healthcare where the pharmacy was the hub that joined all the other professionals together. That month we had visitors from around the USA, Costa Rica, Canada and Europe.
Compounding was and continues to be the primary focus of our pharmacy and greatest demand in compounding was anti-aging and hormones. Therefore, we focused our efforts initially on what was called Natural Hormone Replacement Therapy (NHRT). Later the word “Natural” was replaced and the term was changed to Bio-identical Hormone Replacement Therapy or BHRT. This soon expanded into treatments for Luteal Phase Defect for pregnant moms, the recognition of and alternative treatments for PMS and other female health related issues including libido and energy. As we became better known for treatments of specifically female issues, women would ask us what we could do for their husbands and boyfriends. This led to an additional focus on male hormone related problems.
Our Expertise and Knowledge
Specialty products and preparations that required additional expertise, knowledge and equipment seemed to be the next logical move in our growth and development. Our sterile clean rooms met the stringent requirements of USP <797> compliance and have become a cornerstone of our compounding practice. Many of our patients have had their sight saved or their lives dramatically changed due to the unique sterile preparations that we make. From fortified ophthalmic antibiotics and ophthalmic injections that reverse or slow down age related macular degeneration to sterile preservative-free intrathecal injections for chronic non-malignant pain management, we have been able to make a variety of life changing compounds.
Mark Drugs Opens Deerfield Location
In May 2008, we opened our Northshore location in Deerfield, IL. It houses state-of-the-art compounding labs, physician exam rooms, conference/lecture facilities and an exceptional nutrition center. It is much more compact than our Roselle location but has established a strong position in the northern suburbs of Chicago as a compounding leader and innovator.
An aspect of our pharmacy that we are extremely proud of is the recognition and respect of our colleagues. One measure of how good a job we are doing is accreditation. We are the First PCAB Accredited Compounding Pharmacy in the state of Illinois. Accreditation means that we are held to a higher standard and that we have voluntarily opened ourselves to inspection and assessment of our activities, policies and procedures. This is an arduous process to go through and sustain and it typifies our commitment to excellence. More details about the significance of pharmacy compounding accreditation may be found at www.pcab.info.
Not everything that we compound is directly for humans. We make lots of products that enhance the human condition by enhancing the health and welfare of pets. We prepare veterinary medications for hundreds of pets each month as well as their owners. Our goal is to work directly with patients and clients and team with veterinarians, physicians, other health care providers and caregivers to improve the quality of care and the quality of life for all who we come in contact with.
Meeting the Needs of our Patients
Over the years, we have been continually challenged with issues such as pain management, nebulizer combinations, nausea related to radiation, chemotherapy and motion sickness; hospice related comfort management, adjunctive wound care, veterinary dosing problems and a variety of other areas. We always meet the challenge with a positive “We can do” attitude.
For over 20 years we have focused on improving the health and welfare of our patients. The ultimate goal has always been to create an overall state of wellness. Our motto truly speaks to this goal “Better Health and Care, Not Just Healthcare!”, and we will continue to try to live up to this ideal.
We are not hiring at this moment.