FDA allows pharmacies to produce alcohol-based hand sanitizers amid shortage

Aileen Cerrudo   •   March 26, 2020   •   851

The Food and Drug Administration (FDA) has allowed pharmacies to produce their own alcohol-based hand sanitizers to cope with the supply shortage.

According to the FDA, there has been an increase in the demand for alcohol-based products amid the increasing threat of the coronavirus disease (COVID-19) in the country.

Based on FDA Circular No. 2020-11, licensed drug stores, hospital pharmacies, institutional pharmacies, and other stakeholders will be allowed to produce their own alcohol-based hand sanitizers for consumer and health care personnel use.

The FDA also provided several guidelines to ensure pharmacies will produce safe, effective, and acceptable quality alcohol-based products for public use.

Several of the guidelines include: the compounding should be done by a duly registered and licensed pharmacist. They would also have to follow strict hygiene and personal protective equipment requirements.

The location for the compounding, including all the equipment should also be properly sanitized and maintained.

“This Circular is hereby issued as an interim guideline for the pharmacy compounding of alcohol-based hand sanitizers in response to the need for increased production of these products in the Philippines,” the circular reads. AAC

Facility-based isolation for asymptomatic, mild COVID-19 cases now mandatory

Marje Pelayo   •   September 25, 2020

MANILA, Philippines — The Inter-Agency Task Force (IATF) is now requiring facility-based isolation for confirmed asymptomatic and mild coronavirus disease (COVID-19) cases through IATF Resolution 74.

The new policy however, exempts patients who are considered vulnerable or having comorbidities and their home meets the conditions specified in the Department of Health (DOH) and the Department of the Interior and Local Government (DILG) Joint Administrative Order 2020-0001. 

Likewise, another exception is when the Ligtas COVID-19 Centers within the region are fully occupied and the local government unit does not have sufficient isolation facilities.

COVID-19 vaccine approval in PH possible in April 2021 – FDA

Robie de Guzman   •   September 25, 2020

MANILA, Philippines – The country’s Food and Drug Administration (FDA) on Friday said the approval of a vaccine against novel coronavirus disease may be possible in April 2021.

During a virtual press briefing, FDA Director General Eric Domingo said this is “the best case scenario” if clinical trials are completed on schedule.

“If clinical trials are completed by December or January, and a company would file an application with FDA, it’s possible that by April 2021 we will have an approved vaccine,” he said.

“Talagang best case scenario yun, meaning yung three to six months, magiging three months; assuming that they will complete all their analysis and submitted immediately to FDA,” he added.

In the same briefing, Department of Science and Technology (DOST) Secretary Fortunato dela Peña said the time period of three to six months is the experts’ estimate on the completion of Phase III clinical trials for vaccine candidates.

“When they say 3-6 months, we prefer to use the longer forecast in our estimates. That would indicate in that period they would have finished clinical trials and probably already submitted to FDA their application and results of their trials,” he said.

Dela Peña said the World Health Organization (WHO) is set to release its list of selected vaccines and protocols in October and that the fastest that they can start the clinical trials will be in the last quarter of 2020.

“The vaccine trials according to experts will range from 3 to 6 months. I think the very early forecast that we have of second quarter 2021 is still the best forecast we can give,” he said.

The DOST said the Philippines is currently negotiating with 17 vaccine developers from other countries and six of them have already signed confidentiality disclosure agreements that would allow the sharing of their earlier trial results.

Among the six vaccine developers are Russia’s Gamaleya Research Institute and China’s Sinovac.

The FDA earlier promised it would expedite the approval procedures but assured that no steps will be skipped to ensure public’s health and safety. – RRD (with details from Correspondent Aiko Miguel)

Iloilo City placed under MECQ from Sept. 25 until Oct. 9

Marje Pelayo   •   September 25, 2020

MANILA, Philippines — Iloilo City has been placed under modified enhanced community quarantine (MECQ) effective September 25 until October 9 due to the increasing number of coronavirus disease (COVID-19) cases in the city.

According to Presidential Spokesperson Harry Roque the new measure is based on the issued Inter-Agency Task Force (IATF) Resolution 74 which also requires facility-based isolation for confirmed asymptomatic and mild COVID-19 cases.

However, the resolution exempts patients who are considered vulnerable or having comorbidities as confirmed by the local health officer.

Another exception would be when the Ligtas COVID-19 Centers within the region are fully occupied and the local government unit does not have sufficient isolation facilities.

On Tuesday (September 22), 33 employees of the Iloilo City Hall tested positive for COVID-19 prompting the three-day temporary closure of the establishment beginning Wednesday (September 23) as declared by Mayor Jerry Treñas in Executive Order No. 215-A.

Prior to that, 13 barangays in the city were placed under total lockdown due to the increase in community transmission of COVID-19.

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