Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Friday, December 6, 2019
FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk
Liveyon Labs Inc. and Liveyon LLC warned that their stem cell products lack required FDA approval and represent a potential risk to the public health
The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination and deficient environmental monitoring. These deviations create potential significant safety concerns that ...
A. 1. Except for dosages medically required for a period not to exceed forty-eight (48) hours which are administered by or on direction of a practitioner, other than a pharmacist, or medication dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled dangerous substance included in Schedule II, which is a prescription drug as determined under regulation promulgated by the Board of Pharmacy, shall be dispensed without an electronic prescription of a practitioner; provided, that in emergency situations, as prescribed by the Board of Pharmacy by regulation, such drug may be dispensed upon oral prescription reduced promptly to writing and filed by the pharmacist in a manner to be prescribed by rules and regulations of the Director of the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control.
2. Electronic prescribing shall be utilized for Schedules II, III, IV, and V, subject to the requirements set forth in 21 CFR, Section 1311 et seq.
3. An electronic prescription with electronic signature may serve as an original prescription, subject to the requirements set forth in 21 CFR, Section 1311 et seq.
4. Prescriptions shall be retained in conformity with the requirements of this section and Section 2-307 of this title. No prescription for a Schedule II substance may be refilled.
5. The electronic prescription requirement provided for in this section shall not apply to prescriptions for controlled dangerous substances issued by any of the following:
a. a person licensed to practice veterinary medicine,
b. a practitioner who experiences temporary technological or electrical failure or other extenuating circumstance that prevents the prescription from being transmitted electronically; provided, however, that the practitioner documents the reason for this exception in the medical record of the patient,
c. a practitioner, other than a pharmacist, who dispenses directly to an ultimate user,
d. a practitioner who orders a controlled dangerous substance to be administered through an on-site pharmacy in:
(1) a hospital as defined in Section 1-701 of this title,
(2) a nursing facility as defined in Section 1-1902 of this title,
(3) a hospice inpatient facility as defined in Section 1-860.2 of this title,
(4) an outpatient dialysis facility,
(5) a continuum of care facility as defined in Section 1-890.2 of this title, or
(6) a penal institution listed in Section 509 of Title 57 of the Oklahoma Statutes,
e. a practitioner who writes a prescription to be dispensed by a pharmacy located on federal property, provided the practitioner documents the reason for this exception in the medical record of the patient, or
f. a practitioner that has received a waiver or extension from his or her licensing board.
6. Electronic prescriptions shall not be utilized under the following circumstances:
a. compound prescriptions containing two or more commercially available products or two or more active pharmaceutical ingredients,
b. compounded infusion prescriptions containing two or more commercially available products or two or more active pharmaceutical ingredients,
c. prescriptions issued under approved research protocols, or
d. if the practitioner determines that an electronic prescription cannot be issued in a timely manner and the condition of the patient is at risk.
7. A pharmacist who receives a written, oral or facsimile prescription shall not be required to verify that the prescription falls under one of the exceptions provided for in paragraph 6 of this subsection. Pharmacists may continue to dispense medications from otherwise valid written, oral or facsimile prescriptions that are consistent with the provisions of this act.
8. Practitioners shall indicate in the health record of a patient that an exception to the electronic prescription requirement was utilized.
9. All prescriptions issued pursuant to paragraphs 5 and 6 of this subsection shall be issued on an official prescription form provided by the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control.
10. a. Effective January 1, 2020, practitioners shall register with the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control in order to be issued official prescription forms. Such registration shall include, but not be limited to, the primary address and the address of each place of business to be imprinted on official prescription forms. Any change to a registered practitioner's registered address shall be promptly reported to the practitioner's licensing board and the Bureau by the practitioner in a manner approved by the Bureau.
b. A practitioner's registration shall be without fee and subject to approval by the Bureau. Such registration shall be valid for a period of two (2) years and may be denied, suspended or revoked by the Bureau upon a finding by the Bureau or licensing board that the registered practitioner has had any license to practice a medical profession revoked or suspended by any state or federal agency.
c. Where the Bureau has revoked the registration of a registered practitioner, the Bureau may revoke or cancel any official prescription forms in the possession of the registered practitioner. Any revocation or any suspension shall require the registered practitioner to return all unused official prescription forms to the Bureau within fifteen (15) calendar days after the date of the written notification.
d. A practitioner that has had any license to practice terminated, revoked or suspended by a state or federal agency may, upon restoration of such license or certificate, register to be issued official prescription forms.
11. a. Except as provided in subparagraph f of this paragraph, the Bureau shall issue official prescription forms free of charge only to registered practitioners in this state. Such forms shall not be transferable. The number of official prescription forms issued to a registered practitioner at any time shall be at the discretion of the Bureau.
b. Official prescription forms issued to a registered practitioner shall be imprinted only with the primary address and other addresses listed on the registration of the practitioner. Such prescriptions shall be sent only to the primary address of the registered practitioner.
c. Official prescription forms issued to a registered practitioner shall be used only by the practitioner to whom they are issued.
d. The Bureau may revoke or cancel official prescription forms in possession of registered practitioners when the license of such practitioner is suspended, terminated or revoked.
e. Official prescription forms of registered practitioners who are deceased or who no longer prescribe shall be returned to the Bureau at a designated address. If the registered practitioner is deceased, it is the responsibility of the registered practitioner's estate or lawful designee to return such forms.
f. The Bureau may issue official prescription forms to employees or agents of the Bureau and other government agencies for the purpose of preventing, identifying, investigating and prosecuting unacceptable or illegal practices by providers and other persons and assisting in the recovery of overpayments under any program operated by the state or paid for with state funds. Such prescription forms shall be issued for this purpose only to individuals who are authorized to conduct investigations on behalf of the Bureau or other government agencies as part of their official duties. Individuals and agencies receiving such prescription forms for this purpose shall provide appropriate assurances to the Bureau that adequate safeguards and security measures are in place to prevent the use of such prescription forms for anything other than official government purposes.
12. a. Adequate safeguards and security measures shall be undertaken by registered practitioners holding official prescription forms to assure against the loss, destruction, theft or unauthorized use of the forms. Registered practitioners shall maintain a sufficient but not excessive supply of such forms in reserve.
b. Registered practitioners shall immediately notify the Bureau, in a manner designated by the Bureau, upon their knowledge of the loss, destruction, theft or unauthorized use of any official prescription forms issued to them, as well as the failure to receive official prescription forms within a reasonable time after ordering them from the Bureau.
c. Registered practitioners shall immediately notify the Bureau upon their knowledge of any diversion or suspected diversion of drugs pursuant to the loss, theft or unauthorized use of prescriptions.
B. 1. Except for dosages medically required for a period not to exceed seventy-two (72) hours which are administered by or on direction of a practitioner, other than a pharmacist, or medication dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled dangerous substance included in Schedule III or IV, which is a prescription drug as determined under regulation promulgated by the Board of Pharmacy, shall be dispensed without an electronic prescription.
2. Any prescription for a controlled dangerous substance in Schedule III, IV or V may not be filled or refilled more than six (6) months after the date thereof or be refilled more than five times after the date of the prescription, unless renewed by the practitioner.
C. Whenever it appears to the Director of the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control that a drug not considered to be a prescription drug under existing state law or regulation of the Board of Pharmacy should be so considered because of its abuse potential, the Director shall so advise the Board of Pharmacy and furnish to the Board all available data relevant thereto.
D. 1. "Prescription", as used in this section, means a written, oral or electronic order by a practitioner to a pharmacist for a controlled dangerous substance for a particular patient, which specifies the date of its issue, and the full name and address of the patient and, if the controlled dangerous substance is prescribed for an animal, the species of the animal, the name and quantity of the controlled dangerous substance prescribed, the directions for use, the name and address of the owner of the animal and, if written, the signature of the practitioner.
2. "Registered practitioner", as used in this section, means a licensed practitioner duly registered with the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control to be issued official prescription forms.
E. No person shall solicit, dispense, receive or deliver any controlled dangerous substance through the mail, unless the ultimate user is personally known to the practitioner and circumstances clearly indicate such method of delivery is in the best interest of the health and welfare of the ultimate user.
Laws 1971, HB 1100, c. 119, § 2-309; Amended by Laws 1972, HB 1546, c. 229, § 4, emerg. eff. April 7, 1972; Amended by Laws 1982, SB 646, c. 120, § 4, emerg. eff. April 6, 1982; Amended by Laws 1990, HB 1963, c. 210, § 9, eff. September 1, 1990; Amended by Laws 1996, SB 1123, c. 306, § 7, emerg. eff. June 10, 1996; Amended by Laws 2008, HB 2460, c. 273, § 2, eff. November 1, 2008 (superseded document available); Amended by Laws 2011, SB 919, c. 239, § 7, eff. November 1, 2011 (superseded document available); Amended by Laws 2012, HB 2942, c. 80, § 5, eff. November 1, 2012; Amended by Laws 2012, SB 1179, c. 83, § 1, eff. November 1, 2012 (superseded document available); Laws 2012, HB 2942, c. 80, § 5, eff. November 1, 2012 (repealed by Laws 2013, SB 977, c. 15, § 72, emerg. eff. April 8, 2013) (superseded document available); Amended by Laws 2013, HB 1783, c. 323, § 1, eff. November 1, 2013 (superseded document available); Amended by Laws 2018, HB 2931, c. 255, § 1, eff. January 1, 2020 (superseded document available).
FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
The U.S. Food and Drug Administration today announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device. The platform enables the crowdsourcing of medical information from health care providers to guide potentially life-saving interventions and facilitate the development of new drugs for neglected diseases. The repository is a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), which is part of the National Institutes of Health (NIH).
“The CURE ID application focuses on drugs for infectious diseases lacking adequate treatments, including neglected tropical diseases, emerging infectious threats and infections caused by antimicrobial-resistant organisms. When health care professionals directly input their clinical cases into the app, CURE ID allows these real-world experiences to be organized and analyzed much faster, making it easier to spot promising new uses for existing drugs,” said Amy Abernethy, M.D., Ph.D., FDA Principal Deputy Commissioner. “Our hope is that this app will serve as a connector among major treatment centers, academics, private practitioners, government facilities and other health care professionals from around the world and ultimately get treatments to patients faster.”
The repository captures clinical outcomes when drugs are used for new indications, in new populations, in new doses or in new combinations. Health care professionals generally may choose to prescribe or use a legally marketed human drug or medical device for an unapproved or uncleared use when they judge that the unapproved use is medically appropriate for an individual patient. The systematic collection of real-world experience in the app will help identify drug candidates for additional study, encourage further drug development, and may serve as a resource for practitioners making individual patient treatment decisions in the absence of established safe and effective options. Repurposing approved drugs for new clinical indications can potentially offer an efficient drug-development pathway for treatments of diseases and conditions that have few or no therapeutic options.
“The potential importance of new therapeutic opportunities from repurposing drugs can’t be understated,” said NCATS Director Christopher P. Austin, M.D. “The CURE ID platform exemplifies how collaborative efforts can spark innovations that benefit patients. This new platform harnesses the power of crowdsourcing to help gather medical observations in the field and help identify potentially effective treatments for diseases.”
The app works by collecting a simple case report form from caregivers about their experience using an approved product for an unapproved use. Health care professionals can browse from a collection of cases that have already been documented, including successful and unsuccessful treatments, in addition to viewing relevant clinical trials and those open to enrollment at clinicaltrials.gov. App users can also participate in a treatment discussion forum where they can engage with fellow providers globally. The FDA plans to reach out to health care providers in various disciplines, including infectious and tropical diseases, to encourage them to use the app.
The full launch of the app follows the release of several pilot versions after an initial innovation award was received from the U.S. Department of Health & Human Services IDEA Lab in April 2015. During the pilots, extensive user-testing was conducted in India (2015 and 2017) and South Africa (2016). Additional feedback was also collected from users in the U.S., Europe and Peru. The updated app that launched today includes the addition of a newsfeed, an improved search feature with data from 325 different infectious diseases and syndromes to choose from, and the inclusion of nearly 1,500 initial cases from clinicians and the published literature and over 18,000 clinical trials.
To download and use the CURE ID application, visit https://cure.ncats.io or download “CURE ID” from the App or Play Store.
# # #
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
16 hours ago - According to the suit, compounded medicines “play a critical role in meeting the patients' medical needs” and “serve as an alternative to opioid narcotics.” It says “mass-produced, commercially available drugs prescribed for pain management in pill or injectable form may lead to dependency issues.
16 hours ago - For example, if compounding with bulk substances pursuant to patient-specific prescriptions for nonfood-producing animals, FDA is stating that the drug should be compounded in accordance with applicable United States Pharmacope
FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health
Clinic had significant donor eligibility violations, including donor screening and testing
The U.S. Food and Drug Administration has ordered Gynecology, Reproductive Endocrinology and Fertility Instituteof San Juan, Puerto Rico and its Medical Director and Owner, Dr. Rosa I. Cruz, to immediately cease manufacturing due to significant violations of FDA regulations. An FDA inspection and subsequent record review revealed significant violations of regulations regarding donor eligibility determinations, including donor screening and testing. The clinic’s failure to fulfill these requirements puts patients at risk for exposure to communicable diseases, including HIV and hepatitis.
“Patients use fertility clinics to help them become parents and they rely on these clinics to follow the appropriate regulatory requirements for screening and testing of donors of reproductive tissue. Patients should not have to worry about being at risk or becoming infected with a ...