Monday, November 18, 2013

Maryland Board of Pharmacy Draft Letter to Veterinarians Regarding Rule Changes on Compounding

5) Draft Board Response to Veterinarians

Vet Center - Dr. Cox 071713

Jeffers, VMD - Vet 072613

Burke-Schwarz - Vet 072213

Soverns - Vet 072413

Townsend - Vet 072213

Rubenstein - Vet 072213

Rubenstein II - Vet 072313
Thank you for providing comments in reference to the HB 986 State
Board of Pharmacy – Sterile Compounding – Permits, Chapter 397,
2013, (HB986), prior to the promulgation of the regulations.

Until the new sterile compounding laws become effective (both State
and federal), veterinarians may continue to compound and
dispense sterile products in accordance with applicable standards of
practice to their patients only. Keep in mind that HB 986 applies to
sterile compounding only. Veterinarians may compound a limited
quantity of a particular medication in anticipation of immediate
future need as based on previously
documented prescriptions filled for that medication. Veterinarians
who wish to engage in sterile compounding after the implementation
of the new Maryland law must obtain an additional permit from the
Board of Pharmacy and comply with certain minimum standards.
 Veterinarians who compound non-sterile products do not require an
additional permit from the Board.

If using a pharmacy, a pharmacy would have the ability
to compound in anticipation of receipt of a patient specific
prescription. Any compounded prescription that is dispensed must be

pursuant to a patient specific prescription. See COMAR
This regulation may provide a solution to some veterinarian
concerns. The veterinarian should work with the pharmacy to
arrange availability in emergency situations.

Thank you again for your thorough consideration of the solicitation
for comment posted on the Department of Health and Mental
Hygiene’s website. Drafts of the proposed regulations will be
released informally. Please monitor the Maryland Register for the
initial publication of the proposed revisions to COMAR 10.34.19
Sterile Pharmaceutical Compounding. A 30 day
comment period will follow.
quoted from here

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