News
FDA's Most Recent Guidance: Prescription Requirements Under Section 503A
On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance). The Prescription Guidance sets forth the FDA’s policy concerning prescription requirements for compounding human drug products for identified individual patients under Section 503A of the Federal Food, Drug and Cosmetic Act (FDCA) and addresses: Compounding after the receipt…
Read MoreVeterinary Compounding: Recent State Legislation Updates
State boards of pharmacy continue to have primary responsibility of the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with Section 503A of the Food and Drug Cosmetic Act (FDCA) while the FDA regulates and inspects registered outsourcing facilities licensed under Section 503B of the FDCA. While the exact definition of compounding may vary…
Read MoreFDA Warning Letters Sent to California and Kentucky Compounders
The FDA recently issued two warning letters to compounders in California and Kentucky for violating current good manufacturing practices related to sterility. Ionia Pharmacy, based in Tustin, California, and Spoonamore Drug Co., located in Louisville, Kentucky, were both issued warning letters for deficiencies in: Producing sterile drug products and putting patients at risk, Not receiving…
Read MoreColorado Board of Pharmacy Considering Rule Amendments to Address Medical Board Telehealth Guidelines
As previously discussed on the Baer Law Blog in August, the Colorado Medical Board (Medical Board) adopted Guidelines for the Appropriate Use of Telehealth Technologies in the Practice of Medicine (Guidelines). The Medical Board defined telehealth as: “‘a mode of delivery of health care services through telecommunications systems, including information, electronic, and communication technologies, to…
Read MoreCalifornia & Oregon Pharmacy Update: Pharmacists and Birth Control
In 2016, groundbreaking laws in California and Oregon will allow women to obtain hormonal contraceptive pills, patches and rings directly from pharmacists without a doctor’s prescription — a change many say is more convenient and likely a less expensive option than going to the doctor. Presently, a doctor’s prescription for hormonal contraceptive products is required,…
Read MoreNew Telehealth Guidelines Approved by the Colorado Medical Board: Should Colorado Pharmacists Be Concerned?
The Colorado Medical Board (Board) has adopted Guidelines for the Appropriate Use of Telehealth Technologies in the Practice of Medicine (Guidelines) as the state seeks to enact a new law expanding telehealth services. The Board defines “telehealth” as: ‘a mode of delivery of health care services through telecommunications systems, including information, electronic, and communication technologies, to facilitate…
Read MoreColorado Pharmacy Law: Telehealth and Identifying Valid Preexisting Patient-Practitioner Relationships
The Colorado Medical Board recently published a new draft policy, No. 40-27, on “Guidelines for Appropriate Use of Telehealth Technologies in the Practice of Medicine.” The projected effective date is August 20, 2015. The new guidelines, however, appear to be at odds with the existing Colorado Board of Pharmacy rules that state, in part, the…
Read MoreCalifornia and Oregon To Allow Hormonal Contraceptives Without A Doctor's Prescription
California and Oregon will become the first states to allow women to get birth control pills and hormonal contraceptives directly from their pharmacists, without a doctor’s prescription. California’s rules are expected to take effect after October 1, 2015, while Oregon’s is expected to take effect after January 1, 2016. The contraceptives, however, will not be…
Read MoreCompounding Animal Drugs from Bulk Substances: Draft Guidance Update
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #230 entitled “Compounding Animal Drugs from Bulk Drug Substances.” The draft guidance describes FDA’s policies with regard to compounding animal drugs from bulk drug substances. When final, the guidance will reflect FDA’s current thinking on the issues addressed…
Read MorePhantom Pharmacist-in-Charge Offers
The Oklahoma Board of Pharmacy (Board) is reporting that Oklahoma-licensed pharmacists are being approached by out-of-state pharmacies (OSP) asking them to be their pharmacist-in-charge (PIC) for their Oklahoma license, despite the fact that the Oklahoma licensed pharmacists to not actually work at the OSP. The increased frequency of requests for “phantom” or “absent” PICs is…
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