skip to main | skip to sidebar

Designated Representative and Exemptee

All things related to drug and device wholesalers and home medical device retailers to retain an Exemptee or Designated Representative on-site to conduct their business.

Pages

  • Home
  • CA HMDR Exemptee Certification Class
  • CA Exemptee & CA Designated Representative Classes
  • Florida Certified Designated Representative Exam Prep Course
  • The Exemptee Institute
  • The Designated Representative Institute

Designated Representative Training | Exemptee Training

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'

Return Home:  The Designated Representative and Exemptee Blog

CA Designated Representative online web-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
The Designated Representative Institute

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

SkillsPlus Intl Info Blog

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





Enhanced by Zemanta
Email ThisBlogThis!Share to XShare to FacebookShare to Pinterest
at 5:14 PM
Labels: compounding, fda, Food and Drug Administration, Form 483, Form FDA 483, inspection, observation, pharmacies, pharmacy
Newer Post Older Post Home
Google
Custom Search

From SkillsPlus International Inc.

Loading...

Buy A Course

The top choice for CDR and Exemptee training!
  • CA Des Rep Wholesaler Training Course
  • CA Des Rep 3PL Training Course
  • CA Des Rep Reverse Distrib. Training
  • CA HMDR Exemptee Training Course
Nearly 10,000 students have taken our state license-related training courses!

Top Choice Exemptee Training

Top Choice Exemptee Training
Buy Now! HMDR Exemptee Training Course. Price: $525 per student. For home medical device retailers (HMDR). We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. The top choice in Exemptee training! #2024 #2025

CA Designated Rep 3PL Course

CA Designated Rep 3PL Course
CA Designated Representative-3PL Training Course: $525 per student. For third-party logistics providers.

California Designated Representative Training

California Designated Representative Training
Earn a training affidavit. California Designated Representative training courses for: wholesalers, 3PLs, and reverse distributors. Approved by the California State Board of Pharmacy.

California Designated Representative Training

SkillsPlus International Inc. is the ONLY training provider approved by the California State Board of Pharmacy to offer California Designated Representative training programs for wholesalers, 3PL, and reverse distributors.

California Desig Rep RD License

California Desig Rep RD License
California Designated Representative Reverse Distributor Training Course. Course price is $625 per student.

Designated Representative Training

Designated Representative Training
Training affidavit for CA Designated Reps. For drug/device wholesalers, and third-party logistics providers. Course price is $525 per student.

HMDR Exemptee Application: CDPH 8695

  • Download The HMDR Exemptee Application

Live Florida CDR Training

CDR Resource Center offers live Florida CDR training, on an intermittent basis.

Florida Certified Designated Representative - CDR Exam Prep Course

Florida Certified Designated Representative - CDR Exam Prep Course
Florida CDR Exam Prep Course by CDR Resource Center

California Rx Law Book

  • 2024 Lawbook For Pharmacy - California
  • Pharmacy Law Changes for 2024 - California

Related Services

  • CDR Resource Center - Collaboration Partners
  • CDR Resource Center
  • SkillsPlus International Inc.
  • GTC Consulting
  • Grossman, Furlow and Bayo, LLC

California Exemptee Certification

California Exemptee Certification: California Exemptee Certification

Highly Recommended Online Training Courses


CA Designated Representative 3PL Online e-Learning Course - for third-party logistics providers

California Designated Representative Training Course

California Designated Representative Training Program for drug/device wholesalers

CA Designated Representative Online e-Learning Course for drug/device wholesalers

CA Designated Representative Training Program for drug/device wholesalers

Training for Designated Representative License Applicants at drug/device wholesalers


California Designated Representative Training Courses - Approved by the California State Board of Pharmacy

Designated Representative Training Courses

California Designated Representative Training Courses - Approved by the California State Board of Pharmacy

California Designated Representative Training Courses - Approved by the California State Board of Pharmacy

California Designated Representative Training Wiki

California Designated Representative Training Courses - Approved by the California State Board of Pharmacy

The Largest Selection Of California Designated Representative Training Courses - Approved by the California State Board of Pharmacy

California Designated Representative Training Courses - Approved by the California State Board of Pharmacy

California Designated Representative Online Training Courses - 3 distinct Board-approved programs

California Designated Representative Online Training Courses - 3 distinct Board-approved programs(SkillsPlusIntl)

California Board of Pharmacy Designated Representative Training - presented by SkillsPlus Intl Inc. (DesRepOrg)

California Board of Pharmacy Designated Representative Training - presented by SkillsPlus International Inc.

California Designated Representative Training Courses (Flipboard)

Designated Representative Training | Exemptee Training

Designated Representative Training Courses

California Designated Representative Training Courses

California Designated Representative Training

California Board of Pharmacy Designated Representative Training

California Designated Representative Training Courses

California Designated Representative Training (Medium)

California Designated Representative Training (Podia)

California HMDR Exemptee License Training Certification Course (Boxmode)

California Exemptee Training - California Exemptee Certification 2022 by SkillsPlus Intl Inc. (Webnode)

California HMDR Exemptee License Training Certification (WebStarts)

HMDR Exemptee Online Training

HMDR Exemptee Online Training

CA home medical device retailer (HMDR) Exemptee Online e-Learning Course

Training for HMDR Exemptee License Applicants - for home medical device retailers (HMDR)

California HMDR Exemptee Training for home medical device retailers (HMDR)

California HMDR Exemptee Training for home medical device retailers (HMDR)

California HMDR Exemptee Training for home medical device retailers (HMDR)

California HMDR Exemptee Training for home medical device retailers (HMDR)

California HMDR Exemptee Training for home medical device retailers (HMDR)

California HMDR Exemptee Training for home medical device retailers (Jimdo2)

California HMDR Exemptee Training for home medical device retailers (SkillsPlusIntl)

The Exemptee Institute

The Designated Representative Institute

Florida Certified Designated Representative - CDR Exam Prep Course

Subscribe via feed

Subscribe in a reader

Subscribe via email

Subscribe to Designated Representative and Exemptee by Email

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

Blog List

  • AASM - Am Acad Sleep Medicine
    Zepbound approved by FDA as first sleep apnea medication
    2 hours ago
  • Healio News
    VIDEO: Artevo 850 offers improved comfort for surgeons, patients
    13 hours ago
  • Supply Chain Brief
    Best of Supply Chain Brief for December 20, 2024
    15 hours ago
  • Modern Healthcare Weekly News
    Congress votes to keep government open, abandons health package
    1 day ago
  • Sleep Review
    FDA Approves First Prescription Medication for OSA Patients With Obesity
    1 day ago
  • Home Health Care News
    Judge Hands Down 12-Month Federal Prison Sentence To California-Based Home Care Owner
    1 day ago
  • The Ferrari Consulting and Research Group
    FedEx Elects to Spin Off LTL Freight Business
    1 day ago
  • Frier Levitt
    New Jersey’s Anti-SLAPP Law: A Powerful New Tool to Defend Providers Sued for Protected Speech
    1 day ago
  • Verdict Medical Devices
    The 10 biggest medtech stories of 2024
    1 day ago
  • Logistics Viewpoints
    Supply Chain & Logistics News (December 16th – December 19th)
    1 day ago
  • Medscape Today Headlines
    US FDA Declines to Approve Zealand Pharma's Bowel Disease Drug
    2 days ago
  • HomeCare News
    Health Dimensions Group Announces Aging Trends Webinar
    2 days ago
  • Drug Channels
    Drug Channels News Roundup, December 2024: Crazy Medicare Reimbursements, Independents Grow (Really!), AFP Risks, Pharmacy History, GLP-1 Jokes, and Two Cool Dudes
    4 days ago
  • Designated Representative and Exemptee
    FDA Grants Exemption to Connected Trading Partners - FDA.gov
    1 week ago
  • Health Law Attorney Blog
    New York State Dept. of Health Issues Guidance on Recently Amended Consumer Protection Laws and Postpones New Requirements for Patient Consent Forms
    2 weeks ago
  • The Best Designated Rep & Exemptee Training
    Economic Report on Pharmaceutical Wholesalers and Specialty Distributors
    2 months ago
  • RT: For Decision Makers in Respiratory Care
    Use Instructions Revised for Phasitron 5 IPV Therapy Device to Prevent Patient Harm
    2 months ago
  • The Health, Drug, Prescription, and GMP Supersite
    Combined vaping & smoking increases lung cancer risk
    4 months ago
  • HME News
    Philips CEO: ‘We still are relevant’
    4 months ago
  • SkillsPlus International Info
    Popular cGMP Online Training Courses Updated
    5 months ago
  • Calif Des Rep Training
    The Only Approved California Designated Representative Training
    10 months ago
  • California Designated Representative FAQs
    Who Offers Board-Approved California Designated Representative Online Training Programs?
    10 months ago
  • Designated Representative Training Courses
    The Only Board-Approved California Designated Representative Training Programs For ...
    10 months ago
  • CA HMDR Exemptee Training
    Top 10 Health Technology Hazards – ECRI
    10 months ago
  • HMDR Exemptee Online Training
    California HMDR Exemptee Online Training Certification Course
    10 months ago
  • Five Rivers RX
    FDA Authorizes Florida’s Drug Importation Program
    11 months ago
  • HME Business News
    Briefly: Financial Results Announcement Upcoming; Hearing Aids Use Could Cut Fall Risk
    1 year ago
  • HME Business News
    Briefly: Financial Results Announcement Upcoming; Hearing Aids Use Could Cut Fall Risk
    1 year ago
  • The GMP Professor Blog
    Investigating OOS Test Results – FDA Guidance
    2 years ago
  • CA HMDR Exemptee Certification Class
    California Exemptee Training - for home medical device retailers (HMDR)
    4 years ago
  • CA Designated Rep Training
    Recommended! California Designated Representative Online Training Courses
    5 years ago
Show 10 Show All

Blog Archive

  • ►  2024 (6)
    • ►  December (1)
    • ►  September (1)
    • ►  June (1)
    • ►  May (1)
    • ►  April (1)
    • ►  January (1)
  • ►  2023 (10)
    • ►  October (1)
    • ►  August (1)
    • ►  July (2)
    • ►  June (3)
    • ►  May (1)
    • ►  April (1)
    • ►  March (1)
  • ►  2022 (17)
    • ►  December (2)
    • ►  November (1)
    • ►  October (1)
    • ►  August (2)
    • ►  July (2)
    • ►  June (3)
    • ►  May (1)
    • ►  April (1)
    • ►  March (1)
    • ►  January (3)
  • ►  2021 (15)
    • ►  October (1)
    • ►  September (1)
    • ►  July (4)
    • ►  May (2)
    • ►  April (3)
    • ►  January (4)
  • ►  2020 (44)
    • ►  December (3)
    • ►  November (3)
    • ►  October (5)
    • ►  September (4)
    • ►  August (6)
    • ►  July (3)
    • ►  June (1)
    • ►  May (5)
    • ►  April (3)
    • ►  March (7)
    • ►  February (3)
    • ►  January (1)
  • ►  2019 (49)
    • ►  December (5)
    • ►  November (2)
    • ►  October (1)
    • ►  September (5)
    • ►  August (5)
    • ►  July (5)
    • ►  June (4)
    • ►  May (3)
    • ►  April (4)
    • ►  March (5)
    • ►  February (8)
    • ►  January (2)
  • ►  2018 (40)
    • ►  December (5)
    • ►  November (6)
    • ►  October (9)
    • ►  September (1)
    • ►  August (1)
    • ►  July (2)
    • ►  June (2)
    • ►  May (2)
    • ►  April (4)
    • ►  March (3)
    • ►  February (2)
    • ►  January (3)
  • ►  2017 (49)
    • ►  December (2)
    • ►  November (3)
    • ►  October (7)
    • ►  September (3)
    • ►  August (5)
    • ►  July (7)
    • ►  June (2)
    • ►  May (5)
    • ►  April (6)
    • ►  March (2)
    • ►  February (3)
    • ►  January (4)
  • ►  2016 (66)
    • ►  December (5)
    • ►  November (4)
    • ►  October (2)
    • ►  September (5)
    • ►  August (3)
    • ►  July (5)
    • ►  June (4)
    • ►  May (1)
    • ►  April (7)
    • ►  March (13)
    • ►  February (10)
    • ►  January (7)
  • ►  2015 (63)
    • ►  December (6)
    • ►  November (7)
    • ►  October (15)
    • ►  September (8)
    • ►  July (4)
    • ►  June (8)
    • ►  May (3)
    • ►  April (3)
    • ►  March (4)
    • ►  February (3)
    • ►  January (2)
  • ►  2014 (61)
    • ►  December (4)
    • ►  November (7)
    • ►  October (3)
    • ►  September (6)
    • ►  August (4)
    • ►  July (3)
    • ►  June (4)
    • ►  May (7)
    • ►  April (5)
    • ►  March (7)
    • ►  February (4)
    • ►  January (7)
  • ▼  2013 (88)
    • ►  December (6)
    • ►  November (12)
    • ►  October (5)
    • ►  September (12)
    • ►  August (8)
    • ►  July (6)
    • ►  June (7)
    • ►  May (6)
    • ►  April (3)
    • ▼  March (8)
      • CA Pedigree Law Exemptions
      • FDA Considers Compounding Industry User Fees
      • Hamburg Says FDA Needs New Authorities to Regulate...
      • Rotech Files Bankruptcy
      • FDA Focus On cGMP Compliance By Compounders
      • Exemptee Training and Designated Representative Tr...
      • "The Politic" Interviews Margaret Hamburg (FDA)
      • FDA - 2013 Pharmacy Inspections - Form 483 Observa...
    • ►  February (7)
    • ►  January (8)
  • ►  2012 (102)
    • ►  December (6)
    • ►  November (14)
    • ►  October (8)
    • ►  September (8)
    • ►  August (5)
    • ►  July (13)
    • ►  June (4)
    • ►  May (12)
    • ►  April (5)
    • ►  March (9)
    • ►  February (9)
    • ►  January (9)
  • ►  2011 (52)
    • ►  December (7)
    • ►  November (11)
    • ►  October (7)
    • ►  September (5)
    • ►  August (4)
    • ►  July (3)
    • ►  June (5)
    • ►  May (2)
    • ►  April (3)
    • ►  March (2)
    • ►  February (1)
    • ►  January (2)
  • ►  2010 (28)
    • ►  December (2)
    • ►  November (2)
    • ►  October (1)
    • ►  September (2)
    • ►  August (3)
    • ►  July (3)
    • ►  June (2)
    • ►  May (6)
    • ►  April (2)
    • ►  March (2)
    • ►  February (2)
    • ►  January (1)
  • ►  2009 (19)
    • ►  December (2)
    • ►  November (2)
    • ►  October (2)
    • ►  September (2)
    • ►  August (1)
    • ►  July (4)
    • ►  June (6)

Disclaimer & Privacy Policy

All data and information provided on this site is for informational purposes only. This blog makes no representations as to accuracy, completeness, currentness, suitability, or validity of any information on this site and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use. All information is provided on an as-is basis. We use third-party advertising companies to serve ads when you visit our website. These companies may use information (not including your name, address, email address, or telephone number) about your visits to this and other websites in order to provide advertisements about goods and services of interest to you. If you would like more information about this practice and to know your choices about not having this information used by these companies, click here.

SkillsPlus International Inc.

SkillsPlus International Inc.
SkillsPlus International Inc. Logo