Pharmacies Legal & Compliance
Guidance
Guidance
Pharmacy practice revolves around the distribution, compounding, disposal, and preparation of medications and this activity is regulated by the state and the Food and Drug Administration (FDA). The distribution of drugs in the US Healthcare system created to manage patient care is classified into: Generic (These are pharmaceuticals that are patented but can be produced by many different companies), Branded (Pharmaceuticals that are patented and manufactured exclusively by a company), and Specialty (which are made to address costly medical issues). The Food and Drug Administration (FDA) was founded because of the Pure Food and Drug Act (1906), which focused in regulating and prohibiting misbranding of food and drugs. The key reason as to why this Act eventually became The Food, Drug, and Cosmetics Act (1938) was due to the Supreme Court ruling that the Act only prohibit misleading therapeutic claims, not false therapeutic statements. The Act highlights the importance to the safety and criminalization of false therapeutic claims, and that it requires distributors’ transparency to list ingredients, warnings, and indications. This extended to medical (therapeutic) devices and cosmetics. Concurrently, it also helped decrease rate of indemnification for Durable Medical Equipment (DME). And this current act serves as the primary basis of the FDA, which resulted to a couple of amendments to the law. Some of them are:
- The Durham-Humphrey Amendment – organized drugs into two classes:
- Prescription drugs (Rx) – require professional supervision to acquire. These drugs target specific symptoms and illnesses.
- Over-the-counter drugs (OTC) – allow patients to acquire them without any professional supervision or prescription, so it can relive them of any vexatious symptoms caused by illness.
- The Kefauver-Harris Amendment – this was created due to the breakthrough of ex-post-facto of Thalidomide causing birth defects. This promoted the foundation and modern framework for drug approval. As per the FDA (https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process), the process include:
- Discovery and development
- Preclinical research
- Clinical research
- FDA review
- FDA- post market drug safety monitoring
- The Medical Devices Amendment Act – this helped differentiate pharmaceuticals from medical devices. Stating that “medical devices are instruments that do not cause chemical reaction”. It also provided some strict guidelines for pre-market approval and divided medical devices into three classifications; namely Class I, Class II, and Class III.
- The Comprehensive Drug Abuse Prevention and Control Act (1970) – this Act resulted to the conception of the Drug Enforcement Administration (DEA). It controlled drug categorization, procurement, distribution, indication, and registry.
Those are just some examples of the federal rules and regulations that the pharmacies account for to ensure safe and proper practice. There are over 22,000 independent pharmacies in the US and one of the key steps in opening your own independent pharmacy, aside from research, business planning, and your start-up capital, is the legal and operational requirements. The importance of a full-service healthcare law firm, whether you are a start-up or a fully operational pharmacy, is so you could be apprised of legal rights and to stay on top of legal and regulatory compliance. Cohen Healthcare Law Group has worked with thousands of businesses that accelerate health and wellness, with a good number of them being in the pharmacy business. We serve different types of pharmacies, such as:
- Community or retail pharmacy – healthcare facility that allows public to access to medications and comprehensible health advice.
- Industrial pharmacy – includes distribution, manufacturing, marketing of drugs. Industrial pharmacists are responsible for quality control of drugs.
- Compounding pharmacy – a special type of pharmacy that produces customized medications that are not available at a standard and commercialized pharmacy.
- Consulting pharmacy – Evaluate acceptability, safety, and risks of a drug to a patient. It provides advice and regiment reviews based on a the health history of the patient
- Ambulatory care pharmacy – specializes I outpatient care.
- Hospital pharmacy – focuses on the care of medical centers.
Clinical pharmacy – works directly with physicians within a clinic. Clinical pharmacists often perform duties beyond the whole dispensing and processing of orders.
Some of the legal issues we help our pharmacy clients with, but not limited to, are:
- Business formation
- Regulatory compliance
- Employment agreements
- HIPAA Compliance
- Mergers & acquisition (M&A)
- Fulfillment agreements
- Indemnification agreement
- Other business agreements
FAQ
Great! Let us know and we’ll do a conflicts check and then send you an engagement letter. Typically we want to know if we are going to represent you as an individual, or your entity (corporation or LLC); we’ll also want to know your website and some basic contact information.
Review our legal services to see some of the areas we like to work in; check our testimonials, client roster, and experience; read some of our blog posts; check out our Linked In community; or just call or email us to explore. Put simply, we represent health and wellness products, technologies, practices and ventures that accelerate health and healing.
We are very comfortable working with clients via phone and email. You can sign, scan and email the engagement letter, and submit the advance by check or online.
The answer depends on the complexity of the project. Each client’s situation is different. We want every client to receive the best possible advice, and so we want to be in a position to devote as much time as is required to do that. Look to our testimonials, client roster, and experience. We work with our clients effectively and efficiently and build long-term relationships based on mutual trust. We bill hourly and do not offer project or flat fees. Lawyering is an art, not a science – we’re intuitive as well as skilled lawyers.
Yes, like most law firms, we require an advance against fees and costs. Our typical advance ranges from $3,500 – $10,000. We offer our expertise and savvy and work hand-in-hand with you toward your goals. Occasionally, we will offer you a one-hour consult as a way to jump-start our work together, and give you an overview of critical issues, with guidance on the critical business cross-roads you’re facing. We do not take equity or deferred compensation.
Our Firm doesn’t quite “quotes” or answer “how much does it cost.” Through long experience, we’ve found that the answer is pretty much meaningless. Some lawyers and law firms give quotes, but if you read the accompanying disclaimer, you’ll see that the disclaimer basically says that you can’t depend on the quote for anything. In our long experience, “how much it costs” depends on a lot of variables, including:
- What the client is asking for
- What the client really needs
- What the client doesn’t know they don’t know
- What we discover as we dive into the legal research and analysis
- How complicated the problem really turns out to be
- How much client will want to do on their own
- Whether we can find some elegantly simple solutions to sub-parts of the puzzle
- What decisions we make together, and separately, as we explore the puzzle and put solutions and strategies together
In many cases, we might think a project is very complex but then as dig in, we can make executive decisions and recommendations that save the client dozens of hours of lawyer time and tens of thousands of dollars. This happens a lot with our clients. In other cases, the client might think the problem is simple but as we start to review it, the puzzle is much larger; sometimes the client throws in extra facts and complications at the last minute, and that will increase the expense and work; sometimes we’ll give the client “homework” so they can DIY a piece, taking it outside the need for lawyer time.
One thing we do is get our clients frequently on the phone. We find that the Legal Strategy Session often cuts through the fog. Where we need to do a chunk of written legal work, we’ll do so and let you know that’s what we think is needed. Where we can be more efficient with a call, we’ll tell you that as well.
Many clients come us after having wasted tens of thousands of dollars with other lawyers. Read our testimonials. We’re here to provide a lot more value than the retainer—our business model and Firm policy is to provide at least 3-5 times the value back to you. That’s our model and we’re sticking to it. We’re not trying to sell you on a “cheap retainer” or promise of discounts. We’re here to solve a big hairy problem and get you where you need to go, as efficiently and productively as we can.
Typically, assessing feasibility involves legal and strategic advice, which we provide in the 45-minute consult, in a way that is appropriate to the time we have together there.
The only way to know is to jump into the process. If you want to know more about us and how we work, browse our testimonials, look at our client rolodex, or review our experience on our website.
Work with us and find out how efficient and engaged we are with your business. We like to work with clients for life. It is a deep and trusting relationship.
Michael’s bio is online here. He has written books on healthcare law and policy, taught healthcarelaw as a faculty member at Harvard Medical School, garnered NIH and other medical research grants, and published over 100 articles in legal and medical journals. Michael speaks all over the world on healthcare topics.
