Government Agency Enforcement
State Board of Pharmacy, DEA, FDA, Medi-Cal, CMS
PHY, NRP, LSC, NSC, WLS, OSF
State Board of Pharmacy, DEA, FDA, Medi-Cal, CMS
PHY, NRP, LSC, NSC, WLS, OSF
Defend both entities and individuals (pharmacy, wholesaler, clinic, RPH, INT, TCH, DR) against enforcement actions by the BOP, DEA, FDA, DHCS, etc. alleging violations related to:
Develop mitigation strategies in response to initial investigations by government agencies to reduce the likelihood or severity of future enforcement action;
Navigate through audits and investigations, in requests for statements, records, and other information;
Represent at Hearing against Interim Suspension Orders and Accusations;
Aid & Assist during Inspections, Written Notices, Orders of Correction, Citations & Fines, and Informal Office Conferences;
Litigate against government-imposed civil monetary penalties and licensure sanctions;
Petition for reductions of penalty, modification of sanctions, early termination of probation, And reinstatement of licensure;
Appeal against denials of licensure, of individual or facility.
Licensing and Pharmacy/Wholesaler Ownership
Board of Pharmacy: PHY (NRP), LSC (NSC), WLS (OSD)
Medi-Cal / Medicare Part B, Medicare DMEPOS
Guide throughout the entire change of ownership process, as either Seller or Buyer
Drafting and review of contracts for purchase or sale of licensed entities
Guidance on applications for facility licenses (Pharmacy, Wholesaler, Sterile Compounding License, Outsourcing Facility, etc.)
Assist owners of independent pharmacies with acquisitions by chains
Appeals and litigation of denial of license (personal and facility)
The specialized area of purchasing, selling, or creating a new start-up retail pharmacy, sterile compounding pharmacy, or wholesaler requires a legal team that understands pharmacy law, regulations, standards of practice, and the business of pharmacy.
At CPL, our transactional team provides comprehensive representation in all types of pharmacy-related transactions. We protect your interests in any purchase or sale of assets or stocks, along with any related commercial real estate leases or purchases.
Transactional law primarily involves contracts and document filings (transactions), as opposed to legal disputes (litigation). Though litigation can be an unfortunate risk of doing business, a transactional lawyer can help implement proper documents and filings for a business, to minimize the risk of litigation in the future. The best business plans not only include contingency plans in the event of a dispute or adverse claim, but also procedural and substantive safeguards to mitigate or avoid disputes altogether. CPL helps its Clients create and effectuate such safeguards.
Challenges are plentiful with the sale and purchase of a pharmacy or wholesaler. One such example is when a business broker is involved whose primary interest may be to push forward a sale to realize his commission. A careful reading of the broker agreement (usually with the Seller) will expressly exclude any legal advice, which appropriately positions the broker as merely a match-maker – their job is to bring together buyers and sellers, and to facilitate any info and documents between them pursuant to the parties’ requests and allowances. A broker’s job does not include advocating for either side, nor ensuring that the Purchase & Sale Agreement fully represents either side’s interests. For these reasons, the typical generic Purchase & Sale Agreement form oftentimes used by a broker can be ambiguous and missing critical essential terms contemplated by the parties. They are not tailored to the highly regulated business of prescription drugs or devices, nor do they contemplate the intricacies of postclosing financial and performance obligations necessary to a pharmacy transaction. CPL can ensure that your purchase and sale agreement is sufficiently comprehensive for the type of transaction you are considering, and that its terms are fair to you in all critical respects.
CPL provides a variety of pharmacy business transaction services for new or growing businesses. Such pharmacy related transactional services include:
This is only a brief list of pharmacy related business transactions, and is by no means comprehensive. Aside from these common transactions encountered by most pharmacies, each pharmacy will likely have unique requirements, business relationships, or goals that require custom documentation. CPL is prepared to meet your transactional needs.
Our CPL transaction team consists of more than sixty years of collective experience, providing comprehensive representation in all types of business transactions and contracts. We are well versed and extremely prepared to protect your interests in any purchase or sale of business assets, including the purchase or sale of an entire company, as well as commercial real estate transactions.
The difficulties associated with business sales and purchases can be many. In a number of transactions, a business broker is involved, whose primary interest may be in completing the sale. Reviewing a brokers’ disclosure statement typically reveals they are not providing legal advice and are not fully representing your interests; they are merely facilitating putting a buyer and seller together. CPL can help ensure that your purchase and sale agreement is sufficiently comprehensive for the type of transaction you are considering, and that terms are fair to you in all critical respects.
CPL provides a variety of business transaction services for new or growing businesses, as well as corporate services specifically tailored for established entities. Such transactional and corporate services include:
* Business Formation or Dissolution
* Bylaws or Shareholder Agreements
* Employee or Independent Contractor Agreements
* Confidentiality & Non-Disclosure Agreements
* Real Estate Purchase or Lease Agreements
* Company Policies
With CPL’s experienced attorneys, we offer recommendations you can trust for the highly technical and specialized services, which may include:
* IP Licensing Agreements
* Intellectual Property Protection
* Trademark or Copyright Registration
* Private Securities Issuance
This is only a sampling of common business transactions, and by no means comprehensive. Aside from common transactions encountered by most businesses, each business will have unique requirements, business relationships, or goals that require custom documentation. CPL is prepared to meet all your transactional needs.
CPL will help you get your business started right, by explaining the benefits and risks involved with the possible types of business ownership, which include:
CPL will assess your unique situation and your overall goals, then work with your tax advisor to help you determine the most appropriate ownership structure for your needs and then assist you in creating it.
CPL offers a unique, all-inclusive Corporation or LLC formation service consisting of:
In addition to the entity formation services, CPL can prepare supporting documentation such as:
For those entities already formed, CPL can draft or review your shareholder agreement, operating agreement or partnership agreement to ensure that your personal assets are protected and that your business is protected should disputes arise in the future. CPL reveals potential opportunities as well as challenges, and plans for them by implementing necessary agreements and documentation.
CPL has helped numerous Clients develop their articles, by-laws, partnership agreements, operating agreements and management agreements that clearly dictate each party’s rights and responsibilities. Through these documents, CPL not only reduces the possibility of future business litigation, but also lays a solid foundation needed to grow and thrive.
After formation, each entity must comply with the CA Corporations Code to retain the
benefits of incorporating. CPL offers annual corporate compliance services which
CPL is prepared to meet your entity formation and ongoing compliance needs.
CPL guides its corporate Clients on matters of formation, ongoing compliance, and resolution of corporate governance disputes. CPL is prepared to protect the interests of your corporation from violations of statutory requirements and standards, thus preserving the stability and value of your company.
Corporate governance consists of rules, processes, and protocol that have been agreed upon in advance and in accordance with the applicable corporations codes. These guidelines and mandated requirements offer stability to the corporation, dictating how the company should be run and how disputes should be handled. Governance is intended to provide clarity and direction to all stakeholders, including the board of directors, shareholders, management and employees.
Strong corporate governance positively affects the firm’s perceived value in the market. Strict enforcement projects stability and can make it easier to raise capital and investment. Common examples of corporate governance violations include:
Violation of corporate governance by any officer, director or member creates problems for all other shareholders and negatively affects company valuation. Corporate governance must be dealt with proactively and aggressively to avoid legal issues for the company and to protect the interests of all other shareholders.
Unlike the many non-attorney services on the internet, which leave you stranded after the Articles of Incorporation are filed, CPL will continue to work with the corporate founding members to draft governing documents and perform annual corporate compliance services to ensure the corporate entity’s continued good standing. In suspected cases of non-compliance, CPL will investigate such suspicions to assess the legitimacy of the suspicion and its level of risk exposure, to then present you with clear pathways of your legal options.
CPL strongly encourages its Clients to NOT use off-the-shelf, DIY policies & procedures unless they make an earnest effort to sit down and expend the necessary time and thoughtfulness needed to render them personalized for their practice. Too many pharmacy owners and PICs hide behind a false sense of security, as their yet-to-be-opened policies & procedures purchased for hundreds or thousand of dollars sit on their shelf gathering dust, only to be cited by a Board inspector because their policies & procedures conflict with their practice, or are missing legally necessary policies & procedures.
CPL’s compliance team will work with you to:
CPL can help you with your audits, whether governmental or non-governmental.
CPL has helped hundreds of owners of pharmacies and drug/device wholesalers in every aspect of a buy-sell transaction. From Corporate Formation, Purchase & Sale Agreements, Lease Assignments/Subleases, and Post-Closing Transactions, CPL can advocate for its Client to minimize risk exposure during and after the transition of ownership.
People fight about a wide range of things, even though they may be health care professionals. When they do, most seek a quick and painless dispute resolution. Whether the fight is about a competitor harming your reputation and business, someone stealing your patient lists and other trade secrets, matters of unpaid bills or other monies owed, lease disputes with your landlord, or any other disagreement with anything having to do with aspect of your business, CPL can help you by presenting you all of your legal options and then navigating you through them.
California’s wage and hour laws are complex, governing all pharmacies and licensed health professionals. CPL can help you navigate through the myriad of regulations concerning meal breaks, rest breaks, overtime pay, minimum wage pay and other common wage issues affecting the pharmacy industry. CPL’s encourages its Clients to be pro-active and always have up-to-date employee handbooks and policies and procedures. These written guidelines are then implemented in practice through individualized hiring, on-boarding and discipline programs. All of our recommended policies and procedures are designed to position CPL Clients to mount a defense before the Department of Labor or in state and federal court.
CPL’s wage and hour practice is complemented by our labor and employment practice. We routinely advise Clients on harassment and discrimination laws, including sexual harassment, gender discrimination, pregnancy discrimination, and age discrimination. While we aggressively work with our clients to mitigate exposure, we understand that not every lawsuit can be prevented and there are times our clients need zealous representation in court. Our lawyers have over twenty years of experience in mediation, arbitration, and trial for employment-based claims in state and federal courts.
COVID 19 has drastically changed the way businesses operate in California, and the pharmacy industry is no exception. When it comes to COVID 19 employment-leave policies, our team of attorneys are on top of the almost daily changes. Contact us to evaluate whether your pharmacy complies with COVID 19 written workplace and leave policies. Any deficiency in this area can lead to costly COVID 19 driven lawsuits.
The pharmacy industry has seen a steady rise in health care fraud litigation based on Medi-Cal, Medicare, an insurance provider violations. CPL attorneys are well versed in defending claims based on fraud and violations of the False Claim Act, and will represent you through the legal process. With pharmacist-attorneys who have prior experience in pharmacy operations and prescription drug distribution, we are intimately knowledgeable about the most the inner workings of a pharmacy operation and are prepared to mount a vigorous defense.