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Saturday, March 2, 2013

FDA - 2013 Pharmacy Inspections - Form 483 Observations

The FDA is posting their observations, via Form 483, of pharmacies that they've inspected re: compounding.

ORA FOIA Electronic Reading Room > 2013 Pharmacy Inspections:

"2013 Pharmacy Inspections"

'via Blog this'

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Related articles

  • High-Risk Compounding Pharmacies Targeted for FDA Review - Bloomberg
  • FDA: Problems found at another facility of sister company of pharmacy tied to meningitis





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  • CDR Resource Center - Collaboration Partners
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The Exemptee Institute

The Designated Representative Institute

Florida Certified Designated Representative - CDR Exam Prep Course

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Each State's Information

  • CA HMDR License Applications (including Exemptee)
  • CA Lawbook for Pharmacy - Free Online
  • CA Pharmacy Law Changes
  • CA SB752
  • CA Designated Representative Reverse Distributor
  • CA St Board of Pharmacy - Designated Representative (Exemptee) Applications
  • CA St Board of Pharmacy - Contacting Them
  • CA St Board of Pharmacy - Mtg Info
  • FL - Certified Designated Representative - Candidate Information Booklet (CIB)
  • FL - DBPR DDC - Certified Desig Rep Application
  • FL - CDR Printable Law Book

Glossary - Exemptee & Designated Representative

Computer Based Training (CBT)
This is closely related to other e-learning or eLearning terms, such as: online training, web-based training (WBT), internet-based training (IBT), digital training, virtual training, e-training (technology based traiing, TBT). e-learning refers to all forms of electronically supported learning and teaching.
Designated Representative
A California designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices.
Designated Representative-3PL
An individual approved by the board to provide sufficient and qualified supervision of a third-party logistics provider’s place of business. The designated representative-3PL shall protect the public health and safety in the handling, storage, warehousing, distribution, and shipment of dangerous drugs and dangerous devices. (CA BOP).
Designated Representative-Reverse Distributor
An individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor (CA Board of Rx - Desig Rep RD).
DRIC
Designated Representative In Charge (DRIC)
e-Learning
Also referred to as eLearning. A wide set of applications and processes, such as Web-based learning, computer-based learning, virtual classrooms, and digital collaboration.
Exemptee
A California exemptee is an employee that meets the required knowledge and training mandated by California Health and Safety Code 111656.4.
HMDR
Home Medical Device Retailer (HMDR) Licensing Program. This Program licenses all California and Out-of-State facilities and businesses who supply medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries.
Manufacturer
California law defines a “manufacturer” as any person who prepares, derives, produces, compounds, or repackages any drug or device except a pharmacy that manufactures on the immediate premises where the drug or device is sold to the ultimate consumer. (B&P § 4033(a), (b), (c); see also H&S § 109970.)
NCDQS
At the National Coalition for Drug Quality & Security (NCDQS), our accreditation programs for wholesale drug distributors go beyond the most stringent state and federal regulations to include best practices in maintaining the quality and security of drug products.
SOP
SOP is the abbreviation for Standard Operating Procedures. Both the Board of Pharmacy and the HMDR require SOPS.
VAWD
The Verified-Accredited Wholesale Distributors (VAWD) accreditation is for facilities engaged in the act of wholesale drug distribution. The VAWD program has been rebranded as the "NABP Drug Distributor Accreditation" program.
Wholesaler
Under California law, a “wholesaler” is any person who acts as a wholesale merchant, broker, jobber, customs broker, reverse distributor, agent, or a nonresident wholesaler, who sells for resale, or negotiates for distribution, or takes possession of, any dangerous drug or device. (B&P § 4043(a).)

Well Respected Training & Certification Services

  • CDR Resource Center - Collaboration Partners
  • SkillsPlus International Inc.
  • CDR Resource Center
  • The Designated Representative Institute
  • The Exemptee Institute

Other Useful Links

  • Advamed - Advanced Medical Technology Assoc
  • American Association for Homecare
  • CAHSAH - CA Assoc for Health Svcs at Home
  • CAMPS - CA Association of Medical Product Suppliers
  • CHAP - Community Health Accreditation Program
  • CMS Durable Medical Equipment (DME) Center
  • COPA - CA Orthotic and Prosthetic Assoc
  • DEA Diversion Control
  • HDA - Healthcare Distribution Alliance
  • HIDA - Health Industry Distributors Assoc
  • IFPW - Intl Federation of Pharmaceutical Wholesalers
  • MDMA - Medical Device Manufacturers Assoc
  • Medtrade - Connecting the HME Industry
  • NACDS - National Association of Chain Drug Stores
  • NAHC - Natl Assoc for Home Care and Hospice
  • NASCSA - Natl Assoc of State Controlled Substances Authorities
  • NASP - Natl Assoc Specialty Pharmacy
  • NAW - National Association of Wholesaler-Distributors
  • NCART - Natl Coalition for Assistive & Rehab Tech
  • NHIA - Natl Home Infusion Assoc
  • NHPCO - Natl Hospice and Palliative Care Organization
  • NMEDA - Natl Mobility Equipment Dealer’s Assoc
  • Pharmacy Wholesaler Virtual Trade Show - RxInsider
  • The 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors
  • Two Labs Pharma (formerly PharmaLicense LLC) - state licensing consultants

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