Pharmacies

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:

1. The Durham-Humphrey Amendment – organized drugs into two classes:
   1. Prescription drugs (Rx) – require professional supervision to acquire. These drugs target specific symptoms and illnesses.
   2. 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.
2. 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:
   1. Discovery and development
   2. Preclinical research
   3. Clinical research
   4. FDA review
   5. FDA- post market drug safety monitoring
3. 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.
4. 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:

1. Business formation
2. Regulatory compliance
3. Employment agreements
4. HIPAA Compliance
5. Mergers & acquisition (M&A)
6. Fulfillment agreements
7. Indemnification agreement
8. Other business agreements

Our legal team have helped many different kinds of healthcare venture, from healthcare start-ups, digital healthcare & telemedicine, dietary supplement & cosmetics companies, medical spas, medical & chiropractic practices, biotech & life sciences, wellness products & services; and we take pride in giving outstanding service to our clients in any shape or form.

Ref. https://www.ncbi.nlm.nih.gov/books/NBK562220/

Ref. https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-hda-role-of-distributors-in-the-us-health-care-industry.pdf

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