At the close of the 2018 session, the Florida Legislature passed Senate Bill (SB) 675, which if allowed to become law by the Governor, will help hospitals and their facilities that are under common control manage their patients’ drugs much more efficiently. Under prior law, the hospitals had to obtain a restricted drug distributor-health care entity permit to allow the … Continue Reading
Category Archives: Pharmacy, Drugs, Medical Devices & Equipment
Subscribe to Pharmacy, Drugs, Medical Devices & Equipment RSS FeedDEA Implements CARA, Enlisting Mid-Level Practitioners in the War on Opioid Addiction
Prior to the Comprehensive Addiction and Recovery Act of 2016 (CARA) only “physicians” could dispense and prescribe narcotic drugs for maintenance and detoxification treatment. CARA expanded who may prescribe for maintenance and detoxification treatment to “qualifying practitioners” (temporarily through October 1, 2021), a broader term than “physicians” that allows for a wider array of practitioners to prescribe. This change opened … Continue Reading
Get your Single IRB lined up for Multi-Site Research
Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted, supported, or regulated by the federal government. While many of the Common Rule changes go into effect in 2018, the single IRB requirement has a compliance date … Continue Reading
Rare but Not Forgotten: FDA Speeds Review of Orphan Drug Requests
Ever heard of Hailey-Hailey Disease? How about factor V deficiency or Hemimegalencephaly? These are a few examples of rare diseases, e.g., those afflicting fewer than 200,000 Americans.… Continue Reading
Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies
The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the exchange plans, the donut hole for Medicare Part D, states’ necessary Medicaid rebates, and certain recipients of 340B drugs.… Continue Reading
DEA Tweaks, Walks Back Changes to Renewal Process
DEA recently revised an earlier announcement that would have eliminated the grace period for renewals of controlled substance registrations. After initially declaring that prescribers and other registrants would no longer be able to renew their expired registrations during a grace period, DEA announced it would instead continue allowing that practice – for now at least. As a result, registrants who … Continue Reading
Deciphering Florida’s New Laws on ARNP and PA Controlled Substance Prescribing
During the 2016 legislative session, Florida granted authority to both advanced registered nurse practitioners (ARNPs) and physician assistants (PAs) to prescribe controlled substances, subject to approval by their supervising practitioner. This change brings these professionals’ authority in line with what most other states allow. However, this was not a complete grant of prescribing authority and, as explained below, leaves these … Continue Reading
Recent CyberSecurity Incidents Emphasize Importance of Cyberinsurance
As the threat of cyberattacks continues to pose daily threats to businesses large and small, more companies have turned to cyber insurance products to shore up protection against these disruptive threats. A spate of recent incidents has highlighted the importance of taking steps to prepare for and mitigate possible damages. As such, healthcare entities have begun exploring Cyberinsurance as a … Continue Reading
Florida’s Adoption of Federal Exemptions for Wholesale Drug Distribution May Benefit Pharmacies, Practitioners and Hospitals
The 2016 Florida Legislature enacted substantial legislation (Ch. 2016-212, Laws of Florida) to bring Florida’s Drug and Cosmetic Act (Ch. 499, Florida Statutes) in line with the federal Drug Supply Chain and Security Act (“DSCSA”). Since the DSCSA preempts state law, the changes were necessary to avoid confusion between the state and federal exemptions to the term “wholesale … Continue Reading
Fighting Prescription Drug Abuse Gets a Little Easier for Florida Providers, Pharmacists
Pharmacies, dispensing prescribers, and certain healthcare facilities in Florida will soon have an easier time complying with controlled-substance reporting requirements.… Continue Reading
Recent Legislative Developments Affecting Florida Pharmacies
Florida’s 2015 Legislative Session ushered in two new laws affecting pharmacies: One addressing pharmacist immunizations (HB 279) and the second clarifies that veterinarians are authorized to dispense compounded drugs and regulates “maximum allowable cost” pricing (HB 1049). In addition, the FDA has delayed enforcement of certain provisions of the federal Drug Quality and Security Act (DQSA) that went into effect … Continue Reading
OIG’s Rejection of Payments for Prescription Transfers Leaves Questions about Central Fill Pharmacy Arrangements.
The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently refused to bless a specialty pharmacy’s request to pay a per-prescription fee to retail pharmacies for “support services” to be provided in connection with prescriptions transferred to the specialty pharmacy (OIG Advisory Opinion 14-06). The OIG found that the per prescription fee could influence the retail … Continue Reading
Guidance Helps Medical Device Companies Determine Substantial Equivalence
When is a medical device substantially equivalent to another device? Like so much else, it depends. On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance that aims to clarify that question. The document is officially directed at FDA staff, but it is equally instructive to companies seeking FDA approval for their devices.
The FDA … Continue Reading
FDA Offers Guidance for Choosing Prescription Drug Names
If you’ve seen your share of prescription drug commercials, you’ve likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations of letters, but naming a drug requires more than a marketing brainstorm session. A recent draft guidance document from the U.S. Food and Drug Administration (“FDA”) shows many considerations go … Continue Reading
FDA Issues Draft Guidance for Drug and Device Information on Social Media
The Food and Drug Administration (“FDA”) recently issued two draft guidance documents relating to the use of Twitter and other social media by drug and medical device companies. Emphasizing that companies must give a balanced presentation of their products, the Agency stated that companies must provide risk information along with any benefit information within a tweet or similar promotional message.… Continue Reading
Florida Board of Pharmacy Clarifies that Pharmacies Can’t Compound Sterile Human Drugs for “Office Use”
The Florida Board of Pharmacy rules allow pharmacies to engage in office-use compounding. Rule 64B16-27.700, FAC. This allows pharmacies to compound drugs for physicians to use in treating their patients in the office without writing a patient-specific prescription. It does not allow the physician to dispense the office-use drugs to their patients (i.e. give the patient a supply to take … Continue Reading
Florida Says Can Do To Medical Cannabis
In the waning days of the 2014 legislative session, the Florida Legislature passed the Compassionate Medical Cannabis Act of 2014. It is a very limited medical marijuana bill with very strict restrictions and conditions on use. The bill allows access to only low-THC (tetrahydrocannabinol) cannabis (so-called “Charlotte’s Web”) for persons with cancer or another condition that produces seizures or … Continue Reading
Florida Acknowledges Exemption for Intracompany Sales of Pharmaceuticals
A new declaratory statement from Florida regulators clarifies the restrictions on intracompany sales of pharmaceuticals. Previously, if one pharmacy in Florida wanted to send a bottle of prescription medicine to its sister pharmacy down the street, it had to obtain a type of wholesale drug distributor permit, as well as provide pedigree papers for the drug. However, the new decision … Continue Reading
FDA Launches Medical Device ID Requirement
On September 24, 2013, the Food and Drug Administration (FDA) finalized a new rule requiring medical devices to bear special ID numbers. The numbers, called Unique Device Identifiers or UDIs, will identify the manufacturer, the specific model of a device, and other information such as batch or lot codes, serial numbers, and expiration dates. The UDIs are intended to improve … Continue Reading
HHS Makes Good on Its Promise: Releases HIPAA Guidance for Refill Reminder Programs
As previously reported, HHS announced earlier this month that it would be providing clarification on the HIPAA Privacy Rule as it relates to marketing and prescription refill reminder programs. On September 19, 2013, HHS made good on that promise when the Office for Civil Rights announced guidance on when refill reminders and other communications about drugs currently being prescribed … Continue Reading
HHS to Revamp Limits on Payments to Pharmacies for Refill Reminder Programs
The HIPAA Privacy Regulations have long required covered entities to seek a patient authorization in order to use or disclose protected health information (“PHI”) for marketing purposes. However, the Office for Civil Rights made it clear in its Q and A on its website that pharmacies were allowed to provide refill reminders to patients without an authorization as this was … Continue Reading
Florida Board of Pharmacy Approves the Centralized Prescription Filling Rule (Central Fill Pharmacy) for Hospital Pharmacies
On August 14, 2013 the Florida Board of Pharmacy voted to approve central fill pharmacy in a hospital setting. Centralized prescription filling or “central fill” is where two pharmacies separate the duties and responsibilities of dispensing a prescription. Generally, one pharmacy will receive the prescription and send it to, or share it with, another pharmacy with which it has an
… Continue ReadingPhysician Face-to-Face Encounter Now Required by Medicare for Extensive List of DME Items
Physicians and Durable Medical Equipment (DME) suppliers need to be aware that, effective July 1, 2013, and to be enforced as of October 1, 2013, Medicare requires a physician/patient face-to-face encounter within 6 months prior to the physicians order for an item on an extensive DME list. This type of face-to-face encounter has been required since 2006 for power wheel … Continue Reading
Supreme Court Rules Pharmaceutical “Pay For Delay” Agreements Are Subject to Anti-Trust Review
The Supreme Court struck a blow for consumers when it ruled the Federal Trade Commission may file suit to prevent pharmaceutical companies from agreeing to pay generic drug manufacturers to keep generic drugs off the market for a specified period of time. Federal Trade Commission v. Actavis, Inc. (June 17, 2013).
The Court ruled that “pay for delay arrangements” … Continue Reading
