LEGAL PHARMACY (MIDTERM) AO 2016-034 and FDA Circulars

RULES AND REGULATIONS ON THE LICENSING OF ESTABLISHMENTS ENGAGED IN THE MANUFACTURE, CONDUCT ON CLINICAL TRIAL, DISTRIBUTION, IMPORTATION, EXPORTATION AND RETAILING OF DRUG PRODUCTS, AND ISSUANCE OF OTHER RELATED AUTHORIZATIONS

Administrative Order No. 2014-0034

Contract Research Organizations (CROs)

AO 2014-0034 Shall apply to establishments in the country, including local government units, government owned and controlled corporations, non-government organizations, other government offices and instrumentalities engaged in the manufacture, distribution, importation, exportation, sale, offer for sale and transfer of drug product. This shall also apply to _____________ and / or Sponsors engaged in the conduct of clinical trials.

FDA pursuant

No drug establishment shall manufacture, import, export, sell, offer for sale, distribute, transfer, promote, advertise and/or sponsor any activity that involves drug product without first securing a License to Operate or an appropriate authorization from __________ to this Administrative Order.

risk management plan (RMP)

All establishments are required to implement a ______ which is a requirement for the issuance of an LTO or other authorization.

RMP

LTO requirement that shall contain details on how to identify, characterize, prevent, and minimize risk relating to products. This shall include pharmacovigilance activities and interventions

registered pharmacist

all establishments engaged in retail whether privately owned or government-owned shall be under the supervision of a _________ when operating for business except otherwise allowed by other pertinent laws

Cold chain management requirement

All licensed establishments engaged in the manufacture distribution, exportation and importation, selling transportation/shipment of vaccines, biologics, and other temperature-sensitive drug products are hereby directed to comply with the ___________

FDA

The _____ shall have the authority to enter any establishment for (1) inspection of compliance and/or (2) verification of submitted documents in relation to any application for issuance of appropriate authorization

Electronic commerce act of 2000

All establishments shall abide with the guidelines of the FDA on electronic submissions and processes of LTO applications into electronic format pursuant to Republic Act No. 8792 or the

Drug manufacturer

Establishment engaged in all operations involved in the production of the drug product.

Drug manufacturer repacker

Establishment that repacks a finished product into smaller quantities in a separate container.

Drug manufacturer packer

Establishment that packages a bulk drug product into its immediate container.

Drug manufacturer-Trader

Establishment which is a registered owner of the drug product and the formulation and procures the RM and packaging components.

Drug distributor exporter

Establishment that exports RM, API, FP for distribution to other establishment outside the country

Drug Distributor-Importer

Establishment that imports RM, API, FP for wholesale distribution to other local FDA-licensed establishment.

Drug distributor-wholesaler

Establishment that procures RM, API, FP from local FDA-licensed establishment for local distribution on wholesale basis.

Drugstore

hall refer to drug establishment where registered drugs, chemical products, dental, medicinal and household remedies are dispensed directly to the general public on a retail basis.

Retail Outlet For Non-prescription Drug (RONPD)

Drug establishment such as a supermarket, convenient store and other similar retail establishment authorized to sell only identified Over-The-Counter (OTC) and household remedy products directly to the general public on a retail basis.

Sponsor

is an individual, company, institution, organization or an entity which takes the responsibility for the initiation, management, and/or financing of a clinical trial.

CRO

refers to a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of the sponsor’s trial-related duties and functions.

Clinical trials

refers to any investigation in human subjects intended to discover or verify clinical, pharmacological and or other pharmacodynamics effects of an investigational products and or to identify any adverse reactions.

Contracting

refers to the formal and documented evidence of activities to be undertaken by the contract acceptor, to its contract giver.

Drug establishments

refers to a sole proprietorship, partnership, corporation, institution, association and organization engaged in the manufacture, distribution, importation, exportation, sale offer for sale, donation transfer, use testing, promotion, advertising, or sponsorship of drug product including the facilities and installations needed for its activities.

Good Clinical Practice

refers to the standard of design for proper and legal clinical practice

Institutional pharmacy

refers to drug establishments which are non-government entities organizations procuring drugs to be dispensed whether at a cost or as part of empliyee’s benefits

Investigational New Drug

refers to a pharmaceutical form of an active ingredient or placebo being tested or used as reference in a clinical trial.

Special Permit

is a form of authorization granted to entities that procure drugs to be used solely for a specific purpose.

QC

clinical trial

bioavailability and bioequivalence

other analyses that determine the safety efficacy and or quality of drug products

testing refers to (4)

muto propio

all licensed establishments must continuously comply with the existing requirements, regulation, and standards, other wise the establishment may be ordered closed or their licensed suspended or revoked _______ or upon petition by any person

90 days, 1 year

All CROs and or sponsors shall be given how many days and for government owned offices, how many years, transition period to comply from the date of effectivity of this AO

Filling of application → Evaluation → Inspection → Decision on application, → validity

LTO process

Pre-opening inspection and Post-licensing inspection

2 types of inspection needed for the application and approval or issuance of LTOs

2 years

Initial issuance of LTO shall be valid for how many years?

3 years

the renewal of LTO shall be valid for how many years?

6 months

Application for regular renewal of license shall be filed withing (___) months from the date of expiration of LTO

120

continuing non-submission of such application upt to a maximum of ____ days

application is filled before the expiration date

prescribed renewal fee is paid up on filing of the application

A sworn statement indicating no change or variation whatsoever in the establishment is attached to the application

automatic renewal shall apply when the ff conditions are met

Major variations

refer to changes in the drug establishment operations that may affect significantly and / or directly the aspects of safety efficacy and quality of drug products

Minor variation

refer to changes in administrative documents and or changes in the drug establishment operations with minimal impact on the aspects of safety, efficacy and quality of drug products.

120 days

Automatic cancellation of LTO if the existing establishment that failed to file an application for renewal after how many days?

FDA Regional Field Offices

Application are initially reviewed by the respective_________to determine the compliance with the administrative and technical requirements.

Drugstore

FDA circular no 2014-025 refers to what guidelines of licensing is for?

DRUG DISTRIBUTORS

FDA circular no 2014-026 refers to what guidelines of licensing is for

Manufacturers

FDA circular no 2014-027 refers to what guidelines of licensing is for

ROPDs

FDA circular no 2014-028 refers to what guidelines of licensing is for

change of ownership

transfer of location

additional activity

Major variation (3)

expansion

change of business name

zonal change in address

Minor variations-prior approval (3)

change in pharmacist or PA

Deletion of activity

minor variation- Notification

PM head, QAM/head, QCM head 4 authorized person for batch release and a pharmacovigilance officer

Credentials of the pharmacist and other qualified personnel in AO 2014-0027

Site Master File

must be submitted in accordance with the latest edition of the Pharmaceutical Inspection Cooperation Scheme (PIC/s)-Good Manufacturing Practice (GMP).

circular 027

Exemption may be granted to Drug Manufacturer-Repacker and Drug Manufacturer-Trader pharmacist to handle another non-manufacturing activity except retailing is said by what circular?

single but have requirements

how many pharmacist is allowed to supervise multiple RONPDs

2

The pharmacist is required to dedicate a minimum of (___) hours a week of physical presence in the RONPD

25

The distance between the two farthest RONPDs must not exceed ___ km in distance;

15

A maximum of how many RONPDs is allowed to be supervised by a single pharmacist.